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Phadia 100

Q: Why is it important to maintain accurate calibration in the Phadia 100, and what steps are outlined for managing calibrators and curve controls during assay runs?

Maintaining accurate calibration in the Phadia 100 is crucial as it ensures the reliability and accuracy of the assay results. The calibration curve, which is established for each lot number, is stored and used in subsequent runs to verify assay performance. The validity of the stored calibration curve is confirmed if the curve controls are within specified limits, with the curve remaining valid for up to 28 days . During assay runs, the instrument automatically assesses whether the calibration curve and controls meet preprogrammed limits. If these checks are passed, the run can be accepted. If both curve controls are outside inner limits in the same direction or one control is out of the outer limit, results are not calculated and the curve is flagged . This process is essential not just for cost efficiency by reducing calibrator usage but also for ensuring assay consistency and accuracy over time . The decision to accept an assay run ultimately lies with the laboratory manager, who must consider other assay performance parameters .

Q: Explain how the Action List is utilized when handling assay-related errors on the Phadia 100, particularly when sample volumes are inadequate.

The Action List is used to address assay-related errors on the Phadia 100, particularly insufficient sample volumes, by providing step-by-step corrective instructions. When an error such as a bent pipette is identified, the Action List advises users to check for sufficient volume in reagent vials, proper placement of ImmunoCAP/Wells on the carousel, and if applicable, the Sample Carousel Cover’s position . Additionally, similar instructions apply for errors like LOW RU, where users are advised to rerun samples if necessary and check for missed pipetting . The Action List helps to systematically troubleshoot errors, ensuring issues like air bubbles or inappropriate pipetting are resolved, which could contribute to sample inadequacy . It also warns not to empty the instrument before performing the actions, as this could hinder identifying the error's root cause ."}

Q: How are errors involving the ImmunoCAP carousel, such as incorrect positioning, typically resolved as per the manual guidelines?

Errors related to incorrect positioning in the ImmunoCAP carousel are typically resolved by first checking if the specific position on the carousel is affected. If an error persists after initial checks, contacting a Phadia representative is advised . You should ensure that the Sample Carousel Cover is correctly positioned and that all tubes and vials are properly shaped and filled according to guideline specifications . The Processing Errors and specific actions to resolve them are detailed in the Action List, which should be followed to correct any errors. Do not empty the instrument before performing the actions suggested, as this can hinder the identification of the error cause . Additionally, for mechanical errors such as obstructed carousel movement, visually check the processing chamber for loose ImmunoCAP or EliA Wells and reposition them if necessary .

Q: What steps are involved in editing a sample ID or removing a sample from a prepared assay run, and why is it crucial to follow these steps carefully?

Editing or removing a sample ID involves entering the Prepare Run mode, selecting Enter Request, and then accessing the Edit Request function. From there, the sample ID can be selected for editing or deletion using specified keys. Confirmations are necessary at multiple points to ensure the right sample is being adjusted or removed. These steps are crucial to prevent unintentional alteration of sample information, which could result in loss of test data, errors in assay results, or incorrect analysis of other samples within the carousel .

Q: How does the Phadia 100 handle and process samples to prevent errors related to method compatibility and dilution specifications during an assay run?

Phadia 100 handles and processes samples to prevent errors by using a systematic approach involving maintenance and reagent handling protocols. Before each assay, a Daily Rinse must be performed, and a Consumption list is used to verify sufficient volume of reagents, such as Washing Solution and Rinse Solution, is loaded correctly . The system ensures samples are loaded in the correct order and place within the Sample Carousel, guided by the software . Instrument dilutions proceed using specific tube specifications, avoiding double-bottom tubes to prevent pipette errors . Method compatibility is checked by the instrument, issuing warnings if incompatible methods like ElyA and ImmunoCAP are attempted simultaneously . This systematic approach, combined with operator guidance on dilution factors and sample handling, minimizes errors related to method compatibility and adherence to dilution specifications during assays .

Q: Describe the process and significance of performing a daily rinse as part of the maintenance routine for the Phadia 100.

Performing a daily rinse on the Phadia 100 is crucial to prevent blockages, microbial growth, and carry-over between assay runs. The process involves disconnecting the Washing Solution Bottle and replacing it with a beaker containing approximately 300 ml of purified water, then rinsing the system . This task should be done at the end of each day the machine has been used, ensuring that the Waste Bottle is emptied beforehand to avoid overflow . The daily rinse maintains the instrument’s performance and prevents errors, requiring about six minutes to complete. Neglecting this step may result in instrument performance issues and assay errors . Regular maintenance, including the daily rinse, thus secures the operational integrity of Phadia 100 ."

Q: What are the criteria for acceptance of the ImmunoCAP Specific IgE assay runs and when can the clinical results be deemed valid for reporting?

Criteria for acceptance of ImmunoCAP Specific IgE assay runs include completing three separate runs with specific conditions. For the first run, there must be a full calibration curve, ImmunoCAP Specific IgE Control tested for three allergens in duplicate, a negative control tested with the same allergens, and at least six individual patient samples also in duplicate. Acceptance criteria for this run require the software to accept the calibration curve, the mean values for the control to be within the given range, and negative controls to be negative . In Runs 2 and 3, single replicate curve controls are used alongside the same control and negative control protocols as Run 1, with acceptance requiring curve controls to be within range and the runs accepted by the software . Total acceptance of the assay results requires fulfilling the criteria for all three runs, pooled coefficients of variation (CV) within runs of less than 6% for controls and patient samples, and a total CV of less than 10% . Once these criteria are met, clinical results can be deemed valid for reporting ."}

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Phadia 100

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English

12-3501-20/12

Phadia® 100
User Manual

Downloaded from www.Manualslib.com manuals search engine

This User Manual is intended to be a convenient source of product informa-
tion for the user of the Phadia100 instrument. Further information is found in
the Directions for Use for the various reagent products and in the manuals for
the optional software.
Information in this document is subject to change without notice.
All pictures displayed in this manual should be regarded as examples only.
This User Manual is not country specific and therefore reference may be
made to methods and/or assays that are not registered or cleared for use in a
specific country. Please consult your local sales office for country specific
information regarding the regulatory status of particular assays or methods
on Phadia 100.

The following designations are trademarks belonging to Thermo Fisher

Scientific Inc and its subsidiaries:
Elia, ImmunoCAP, Phadia, Phadiatop, Quality Club, UniCAP.
Trade mark change
Phadia AB has changed the trademarks of the instrument platforms from
"UniCAP®" and "ImmunoCAP®" to "Phadia®". The new name has been
applied to the instruments and related items, e.g. Software and User Manu-
als. The trademark "ImmunoCAP®" has been removed from the System
Reagents. This is a trademark change only; the change has no impact on
performance or safety.
Embedded third party software: The Phadia 100 instrument may contain
third party software, e.g. third party software from Microsoft. The third
party software is subject to end user license terms of the respective software,
which the user must accept before any use of the Phadia 100 instrument. The
third party software is provided only for use in accordance with these end
user license terms. Any other use of the third party software is strictly
prohibited. Furthermore, the user may not install any additional software to
the Phadia 100 instrument without the prior written approval of Phadia AB.

Phadia 100 User Manual, version 12. This version is valid for Phadia 100
Instrument Version 1.0 and Phadia 100 Instrument Software Version 3.0.
© 2012 Thermo Fisher Scientific Inc and its subsidiaries. All rights reserved.
Manufacturer: Phadia AB,
Rapsgatan 7P, P.O. Box 6460, 751 37 Uppsala, Sweden.
Issued October 1995. Revised May 2012.
ArtNo. 12-3501-20/12

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1. Instrument Specification and Installation 1

2. Routine Assay Run 2

3. Reagent and Sample Handling 3

4. Assay Run Editing Functions 4

5. Assay Run Data Evaluation 5

6. Assay Run Quality Control 6

7. Monthly Calibration 7

8. Quality Assurance 8

9. Methods, Test Panels, Article Management 9

10. Printouts 10

11. Maintenance 11

12. Error Handling 12

13. Repacking 13

14. Accessories 14

15. Index 15

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Phadia 100 - User Manual Instrument Specification and Installation

Chapter 1 - Instrument Specification and

1
1

Installation
This chapter describes technical
specifications and installation procedure

Instrument 2
Intended Use 2
Principal functionality 2
Instrument Guide 3
Sample Carousel 5
Instrument Lifting Points 5
ImmunoCAP/EliA Well Dispenser 6
USB ports/Diskette Drive 6
TCP/IP connector 6
Washing Solution, Rinse Solution and Waste Bottles 7
ImmunoCAP Carousel 7
ImmunoCAP Waste Container 8

Technical Specification 9
Instrument Specification 9
Solid Phase Specification 13

Operational Precautions and Limitations 14

Installation 16
Contents 17
Installation Instructions 18

Parameter Set Up 22
Date/Time 22
Language 23
Default Method 23
Set sIgE Method 24
Contrast 24
Set and Change Passwords 25
Communication Parameters 26
Configure Phadia 100 for TCP/IP 27
Configure computer name 28

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Instrument Specification and Installation Phadia 100 - User Manual

Instrument

Intended Use

Phadia 100

Phadia 100 is a fully automated instrument including software to be used

together with dedicated in vitro diagnostic tests. The instrument is designed to
handle processing of samples, reagents and measuring results and it can be
connected to the software Phadia Information Data Manager (IDM). Phadia 100
is intended to be used in clinical laboratories.

Principal functionality
Phadia 100 is designed to be used together with ImmunoCAP and EliA in vitro
diagnostic tests manufactured by Phadia AB. Phadia 100 yields the same
analytical results from samples of the same specimen as Phadia 250, Phadia
1000, Phadia 2500 and Phadia 5000 within stated tolerance limits. The
instrument includes functions for-distribution of samples, ImmunoCAP and EliA
wells, and reagents,-processing of all assay steps for incubation and washing,-
reading of measuring values, calculations of analytical results, calculation of
statistics and result reporting.The algorithms included in the instrument
software used for calculation of analytical results and statistics are the same as
the ones included in Phadia Information Data Manager (IDM).Up to five
instruments can be connected to an external computer and communicate with
IDM software. When the instrument is connected to IDM software the measuring
values are electronically transferred and calculations of analytical results,
calculation of statistics and result reporting is done by IDM software. Phadia
100 is designed to handle approximately 100 tests per working day.

Solid Phase

For the measurement of the antibodies Phadia 100 can process ImmunoCAP or
EliA Wells. All procedures for EliA Wells should be performed as described for
ImmunoCAP.

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Phadia 100 - User Manual Instrument Specification and Installation

Instrument Guide 1
1

Instrument Front

Pipette Arm Pipette

Washing Solution, USB ports/

Rinse Solution and Diskette Drive
Waste Bottles

ImmunoCAP/
Sample Carousel EliA Well Dispenser
Cover

Printer

Sample Processing Lid/ Keyboard

Carousel Display Processing Chamber

Processing Lid open

Wash Rake

Processing Chamber

ImmunoCAP Carousel
Drainage filter ImmunoCAP/EliA Well
Waste Container

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Instrument Specification and Installation Phadia 100 - User Manual

Instrument Rear

Instrument equipped with USB ports:

USB ports Cooling fan

COM 2 port TCP/IP connector
(COM 1 is used
internally in VGA connector
the instrument) (for service only)

Washing Solution,
Rinse Solution and
Waste Bottles
Voltage selector
and Primary fuses

Power on/off

Secondary fuses
Mains Power Inlet

Instrument equipped with diskette drive:

COM 3 COM 2 COM 1 Cooling fan

Washing Solution,
Rinse Solution and
Waste Bottles
Voltage selector
and Primary fuses

Power on/off

Secondary fuses
Mains Power Inlet

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Phadia 100 - User Manual Instrument Specification and Installation

Instrument Lifting Points 1

Lift the instrument by holding under the instrument. Do not lift the instrument
by the areas indicated in the picture. Too much weight on these spots might
damage the instrument.

Do not lift here!

Please lift here!

Sample Carousel
In the sample carousel you place the reagents
and samples in given positions. The positions
are:
1-48 Positions for calibrators, curve
controls, quality controls, samples,
diluent and dilution tubes
A-D Positions for Conjugate
E Position for Development Solution
F Position for FluoroC
G Position for Diluent
H Position for Stop Solution

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Instrument Specification and Installation Phadia 100 - User Manual

ImmunoCAP/EliA Well
Dispenser
You load ImmunoCAP/EliA Well carriers in the
ImmunoCAP/EliA Well Dispenser. The
ImmunoCAP/EliA Well Dispenser is placed on
top of the processing chamber. Push the cap
away and push the carrier downwards until you
feel it clicking into place.
You will be prompted which ImmunoCAP/EliA
Well carrier to load when you are in the Load
and Start mode. The instrument will
automatically place ImmunoCAP/EliA Well in
the right position in ImmunoCAP Carousel.

USB ports/Diskette Drive

On instruments equipped with USB ports, you
find two USB 2.0 type A ports to the upper right
of the instrument and two USB 2.0 type A ports
on the instrument rear. You can store data on a
USB memory or an external USB hard drive,
and use it in a computer. You can also import
data from a USB memory or an external USB
hard drive, to be used in the instrument. To
connect a barcode reader of USB type, please
contact your local Phadia representative.
On instruments equipped with a diskette drive,
you find the diskette drive to the upper right of
the instrument. You can store data on a diskette
and use it in a computer. You can also import
data from a diskette to be used in the instru-
ment.

TCP/IP connector TCP/IP connector

On instruments equipped with USB ports, you

find a TCP/IP connector to the upper right of the
instrument rear. The TCP/IP connector can be
used for communication to an external com-
puter using the software IDM (Phadia Informa-
tion Data Manager).

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Phadia 100 - User Manual Instrument Specification and Installation

Washing Solution, Rinse Solution and 1

Waste Bottles
You find the Washing Solution, Rinse Solution
and waste bottles to the left of the instrument,
behind the Sample Carousel. When you connect
these bottles to the instrument, please be sure you
connect them in the correct order. The bottles
and tubings from the instrument are marked with
different colours to indicate the correct connec-
tion.
There is a quick-release function on the top of the
nozzles. Press the little button on the nozzle and
the tubing will come off immediately. When you
put the tubing back on the bottle, press the nozzle
on until you hear a clicking sound.

NOTE! Do not unscrew the cap from the bottles

if the tubings are still connected. This can cause
problems with insufficient distribution of Wash-
ing and Rinse Solution due to twisted and stuck
tubings inside the instrument.

Fill the bottles with 1l of Washing Solution and 1l Rinse Solution for one assay
run. When running ImmunoCAP Specific IgA, ImmunoCAP Specific IgG or
ImmunoCAP Specific IgG4 with a full sample carousel, 1 l of Washing Solution
is not enough. Fill up the bottle with Washing Solution.

WARNING! Washing Solution may cause

sensitization by skin contact. Wear protective
gloves!

We recommend that you prepare Washing Solution for a week's consumption

and use this to fill the instrument.

ImmunoCAP Carousel
ImmunoCAP Carousel is placed in the processing chamber. You
ImmunoCAP
find the processing chamber in the middle section of the Holder Disc
instrument. The chamber is opened by pressing the lid open
key. To open the lid, the power must be on. The lid cannot be
opened during processing. ImmunoCAP Carousel consists of
two units, the Elution Wells Disc and ImmunoCAP Holder Disc.
Elution Wells
NOTE! ImmunoCAP Holder Disc is fragile and should be Disc
handled as glass. Always replace if dropped on floor.

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Instrument Specification and Installation Phadia 100 - User Manual

ImmunoCAP Waste Container

ImmunoCAP Waste Container is located on the lower left side of
ImmunoCAP Carousel in the Processing Chamber. The instru-
ment will not indicate when the container is full.
NOTE! ImmunoCAP Waste Container has to be emptied after
every assay run.

WARNING! Waste bottle, ImmunoCAP waste

container and process chamber may be
contaminated by potentially infectious,
biohazard material - take appropriate actions.
Wear protective gloves!

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Phadia 100 - User Manual Instrument Specification and Installation

Technical Specification 1
1

Instrument Specification

Dimensions Width: 680 mm

Depth: 600 mm
Height: 440 mm

Weight Instrument: 46 kg
Total Weight (packaged): 86 kg

Mains Power Supply AC 100 V, 50/60 Hz

AC 120 V, 50/60 Hz
AC 230 V, 50/60 Hz
AC 240 V, 50/60 Hz
Main voltage tolerances +10% / -15%
Main frequency tolerances ±1%
Designed for continuous operation
NOTE! ImmunoCAP 100 must be connected
to a grounded power outlet (protective
ground).

Power 550 VA

Primary Fuses 100/120 V T5AL

230/240 V T 2.5 A L
NOTE! At time of delivery no primary fuses
are inserted. The main voltage selector is set
to 230 V.

Secondary Fuses F903 T1AL

F904 T 100 mA L
F905 T 63 mA L
F906 T 6.3 A L
F907 T 2.5 A L
F908 T5AL
F909 T 63 mA L

Capacity 48 samples loaded at the same time and

processed in each batch

Features Automated dispensing

Automated processing
Automated measuring

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Instrument Specification and Installation Phadia 100 - User Manual

Working Conditions Ambient temperature: 18ºC to 32ºC

Ambient air humidity: 10% to 85% RH
Ambient air pressure: 860 hPa to 1060 hPa
Ambient temperature change: 2ºC/hour
(max.)

Heat Contribution 310 W (average) 1058 Btu/h

Storage Conditions Ambient temperature: -20ºC to +70ºC

Ambient air humidity: 10% to 95% RH

Ambient Sound Level 57 dBA

Warm-Up Time For normal assay: 1 hour

Interface ImmunoCAP 100 equipped with USB ports:

Two USB 2.0 type A ports are located at the
upper right of the instrument and two USB 2.0
type A ports are located at the instrument rear.
The USB ports can be used to connect USB
memorys or external USB harddrives.
One TCP/IP connector is located at the upper
right of the instrument rear. The TCP/IP
connector can be used for connection to IDM
(Phadia Information Data Manager).
One serial port (COM 2) is located at the upper
left of the instrument rear. (COM 1 is used
internally in the instrument.) This connection
will handle serial data communication in
accordance with the RS 232 C standard. The
COM 2 port can be used to connect a bar code
reader.
Pin characteristics (pin no., name, output/ input,
maximum voltage).
Pin 3 Tx output ±12 V
Pin 2 Rx input ±12 V
Pin 7 RTS output ±12 V
Pin 8 CTS input ±12 V
Pin 6 DSR input ±12 V
Pin 4 DTR output ±12 V
Pin 5 GND signal ground
Pin 1 DCD input ±12 V
Pin 9 RI input ±12 V
The serial port must be connected only to
external equipment meeting the appropriate
EMC and electrical safety standards
(i.e., IEC 1010-1, IEC 601-1, IEC 950,
EN 61010-1, EN 60601-1, EN 60950 or
equivalent UL-standard)

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Phadia 100 - User Manual Instrument Specification and Installation

ImmunoCAP 100 equipped with diskette drive:

The serial ports (COM 1, COM 2 and
1
1

COM 3) are located at the upper part of the rear

side of the instrument. These connections will
handle serial data communication in accordance
with the RS 232 C standard.
COM 1, COM 2 and COM3 ports can be setup
for three different kinds of usage.
1) Serial communication to an external
computer
2) Serial communication to chain
communication
3) Barcode reader

Pin characteristics (pin no., name, output/ input,

maximum voltage).
Pin 3 Tx output ±12 V
Pin 2 Rx input ±12 V
Pin 7 RTS output ±12 V
Pin 8 CTS input ±12 V
Pin 6 DSR input ±12 V
Pin 4 DTR output ±12 V
Pin 5 GND signal ground
Pin 1 DCD input ±12 V
Pin 9 RI input ±12 V

These serial ports must be connected only to

external equipment meeting the appropriate EMC
and electrical safety standards
(i.e., IEC 1010-1, IEC 601-1, IEC 950,
EN 61010-1, EN 60601-1, EN 60950 or
equivalent UL-standard)

Liquid Containers Washing Solution bottle volume: 1 litre

Rinse Solution bottle volume: 1 litre
Waste bottle: 2 litres

Rinse Solution Purified water. For references, see

Directions for Use for Washing Solution
(10-9422-01, 10-9202-01).

Washing Solution Purified water, Washing Solution Concentrate,

Washing Solution Additive

Accuracy Pipette 40 µl: 50 µl: 90 µl: 200 µl:

Volume ±0.5 µl ±0.5 µl ±0.9µl ±2 µl (mean value)

Washing Solution 137.5 µl ±7.5 µl (mean value)

Accuracy

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Instrument Specification and Installation Phadia 100 - User Manual

Electrical Safety Phadia 100 complies with the following

Classification directive and standards:
- Low Voltage Directive 73/23/EEC
- In Vitro Diagnostics Directive 98/79/EC

Electrical Safety UniCAP® 100

Standards used:
EN 60601-1: 1990, amendments A1, A11
and A12: 1993, pr A2 and pr A13: 1995
(IEC 601-1, second edition, 1988,
amendment 1, 1991, and amendment 2,
1995) and EN 61010-1: 1993 and pr A2:
1995 (IEC 1010-1, first edition, 1990,
amendment 1, 1992, and amendment 2,
1995)

Phadia 100/ImmunoCAP 100E

Standards used:
IEC 61010-1:2001 (EN 61010-1:2001)
IEC 61010-2-081:2001 and A 1
(EN 61010-2-081:2002)
IEC 61010-2-101:2002
(EN 61010-2-101:2002)

Electro Magnetic UniCAP® 100

Compatibility EN 61000-6-3 (2006) Generic emmission
standard for residential, commercial and
light industrial environments.
EN 61000-6-2 (2006) Generic immunity
standard for industrial environments.
EN 61326 (1997) with amendment 61326/A1
and 61326/A2

Phadia 100/ImmunoCAP 100E

EN 61326:2004 Generic emmission standard
for residential, commercial and light
industrial environments.
EN 61326:2004 Generic immunity standard
for industrial environments.

Service It is very important to maintain Phadia100

regularly as described in chapter 11,
Maintenance. Negligence of the maintenance
leads to Processing Errors as well as Assay
Result Errors. Problems can occur which have
to be solved by an authorized Phadia AB service
technician. Before handing over Phadia 100 for
service, it must be cleaned with Maintenance
Solution kit. Please follow the Directions for
Use in Maintenance Solution kit.

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Phadia 100 - User Manual Instrument Specification and Installation

Training All necessary information about installation

and how to operate Phadia 100 safely is included
1
1

in the shipment. However, if you feel that

additional training is required please contact
your local Phadia AB representative.

Solid Phase Specification

ImmunoCAP

ImmunoCAP are flexible hydrophilic polymer carriers encased

in a capsule. The carrier consists of an activated cellulose
derivative.
Allergen ImmunoCAP carriers, each containing 16 or 10
ImmunoCAP, or packaged as 6 carriers, are separately avail-
able to permit individual selection of the most suitable allergen
panel.
When handling ImmunoCAP, keep the carrier closed to avoid
evaporation of buffer. Do not leave the carrier open for more
than 1 day at room temperature. Otherwise, discard the first
ImmunoCAP.

EliA Well

EliA Wells are Polystyrene Wells coated with antigens or

antibodies.
The wells are packed in carriers, which are additionally stored
in sealed aluminum foilbags with desiccant.
After dispensing EliA Wells, always store the carriers in the
foilbags, which must be properly resealed for stability reasons.
The indicator on the desiccant in the foilbag should always have
a blue color.

NOTE! For stability reasons it is important to

store ImmunoCAP and EliA Wells at 2° C to 8° C.
EliA Wells are moisture sensitive and must be
stored with desiccant.

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Instrument Specification and Installation Phadia 100 - User Manual

Operational Precautions and Limitations

This warning label is located below the Pipette

Arm. There is a risk of skin damage because the
pipette, which carries human body liquids, may
move without warning. Please, keep your hands
out of pipette range.

This warning label is to be placed to the left of

and on the right hand side of the sample carousel
compartment (see Installation Instructions).
When handling human blood, be aware that
there is a biological risk involved.

This warning label is to be placed on the waste

bottle (see Installation Instructions). Phadia 100
waste bottle collects waste liquids containing
human body fluids, which might be infected.
When emptying and cleaning the waste bottle,
take precautions to avoid direct contact with the
liquids. Wear protective gloves.

To ensure the minimizing of disposal of Waste

from Electrical and Electronic Equipment
(WEEE), this label is placed on the Rear Panel
of the instrument, according to the standard for
marking of electrical and electronic equipment
in accordance with Article 11(2) of Directive
2002/96/EC (WEEE), EN 50419. (This applies
within EU countries, Switzerland and Norway
since August 2005.) For disposal of the
instrument, please contact your local Phadia
representative.

This label is a contamination restraint marking

only applicable in the People's Republic of
China. It is placed on the Rear Panel of the
instrument.

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Phadia 100 - User Manual Instrument Specification and Installation

This label guarantees that Phadia 100 complies

with electrical safety standards used in the USA
1
1

and Canada. It is placed on the Rear Panel of the

instrument.

Limitations of Up to four conjugates can be placed in the

the Procedure Sample Carousel. This means that the maximum
number of methods that can be run at the same
time is four. EliA methods can not be used
together with ImmunoCAP methods.

Precaution Phadia 100 is intended for in vitro diagnostic

testing, using reagents of Phadia only. When
operating Phadia 100, reagents manufactured
from human blood components are frequently
used. The source materials have been tested by
immunoassay for hepatitis B surface antigen
and for antibodies to HIV 1, HIV 2 and hepatitis
C and found to be negative. Nevertheless, all
recommended precautions for handling of blood
derivatives should be observed. Please refer to
HHS publication No. (CDC) 93-8395 or local/
national guidelines on laboratory safety
procedures.

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Instrument Specification and Installation Phadia 100 - User Manual

Installation

NOTE! Do not unpack until the instrument has reached room temperature. If
major temperature differences exist (~10ºC), condensation will occur in the
instrument.

Accessory box

Manual box
1. Remove the metallic clips
at the top of the plywood box
with a screwdriver. Save the
metallic clips.

2. Lift the cover of the ply-

wood box and place it beside
the instrument. If wanted lift
the plywood box straight from
the wooden bottom plate and
place it beside the instrument.

3. Remove the four spacing Spacing collars

collars that are placed around
the instrument.

4. For further information see

the Installation Instructions.

Save the empty box!

This box is designed and manufactured for this
instrument only and should be used in future
transportation. Save the metallic clips, the
screws and the spacers!

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Phadia 100 - User Manual Instrument Specification and Installation

Contents 1
1

Phadia 100 is delivered in one box containing the instrument and the accessory
box. The contents in the accessory box should be according to the following list.

Accessory Box

The following accessories are included: Quantity

Mains kit 100/120V 1
Mains kit 230/240V 1
Printer paper (two rolls) 1
ImmunoCAP Holder Disc 1
Elution Wells Disc 1
Sample Carousel 1
ImmunoCAP Waste Container 1
Labels kit 1
Fuse kit 1
Plastic bag 1
Allen key 1
Wrench 1
Feet 4
Media 1
containing
Phadia 100 User Manual
A short introduction fo Phadia 100
How to run an assay in Phadia 100

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Instrument Specification and Installation Phadia 100 - User Manual

Installation Instructions

1. Remove the accessory and the manual 3. Let the instrument rest bottom plate using the Allen
box. on its back on a table with key to unscrew the hexago-
the wooden bottom plate nal screws. Then unscrew
Choose a place with stable ambient tem-
hanging outside the table. the spacers with the 30 mm
perature for the instrument. Do not place it
For doing this, lift the in- wrench. Save the screws and
in sunlight, draft or direct air stream from
strument as instructed in the the spacers in the added plas-
air conditioning. Ensure that there is ap-
part Instrument Lifting tic bag.
proximately 30 cm space around all sides of
Points. Remove the wooden
the instrument.

2. Lift the instrument by the carrying

handles on the wooden bottom plate and
place it on a table.
NOTE! This step requires two persons.
Hexagonal screws
(outside the wooden
bottom plate)
Wooden bottom plate
Spacers (between the
wooden bottom plate
and the instrument)

Table

4. Take the feet and screw them evenly onto the instrument. Do not screw 5. Place the instrument on
the feet too tightly (leave about 8-12 mm of threads visible). a smooth even area. A stable
table is recommended. Level
the instrument using the feet,
Screw the four feet
onto the instrument but do not tighten the feet
too much. The instrument
should be properly levelled a
few millimeters lower on the
side where the Waste Bottle
is placed.

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Phadia 100 - User Manual Instrument Specification and Installation

6. Remove the tape from 7. Remove the tape from the Sample Carousel Cover and the tape
1
1
the Pipette Arm. Gently lift around the Rinse Solution, Washing Solution and Waste bottles.
the arm straight up and move
it to the right, away from the
Sample Carousel.
8. Take out the Sample 9. Choose the proper
Carousel from the acces- mains kit to comply with
sory box. Place it on the your mains voltage. You
left side in front of the find the mains kit and the
bottles. The vial holders fuse kit in the accessory box.
and the sample holders
are in their positions.

NOTE! Phadia 100 must

only be connected to a
grounded power outlet
(protective ground).

10. Select the correct mains kit. Place the enclosed fuses in the Remove the voltage selector
Discard the unwanted kit imme- fuse holders and install the fuse switch and select the correct
diately. Remove the warning la- holders in both the left and right mains voltage by turning the
bel covering the fuse/voltage se- hand position. voltage selector. Place the
lector unit on the rear panel of switch in the instrument. Close
the instrument. the cover and make sure that
Open the fuse/voltage selector the selected voltage is visible
cover using a screwdriver. Insert through the window. Connect
the screwdriver at the top centre the main supply using the en-
and apply pressure. closed cord.

11. Turn the power on in order to open the processing chamber. The chamber
is opened by pressing the lid open key.

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Instrument Specification and Installation Phadia 100 - User Manual

12. Take out Elution Wells

Disc and ImmunoCAP Holder NOTE! The ImmunoCAP
ImmunoCAP Holder Disc Elution Wells Disc
Disc from the accessory box Holder Disc is fragile and
should be handled as glass.
and place them in the Process-
Replace if dropped on floor.
ing Chamber. Place the
ImmunoCAP Holder Disc on
top of the Elution Wells Disc NOTE! Before closing the pro-
in the Processing Chamber. cessing lid, check that the
Align the guide posts. Wash Rake is not in its top or
bottom position, otherwise
Combined together they are it might break something in-
called ImmunoCAP Carousel. side. The Wash Rake can be
Guide posts moved manually and should
be set in a middle position.
Do not exchange Elution Wells Disc between
instruments. Write the serial number of the
instrument on the Elution Wells Disc.

13. Take out the Immuno- 14. Load the paper roll as described in chapter 11, Main-
CAP Waste Container and tenance.
place it in the left corner at the
front of the Processing Cham- Roll Pin
ber. Make sure that the
ImmunoCAP Waste Con-
tainer is hanging loosely un-
der the instrument.
Cut the end of the paper to
an arrow. Insert the paper
in the printer. Paper should
Paper Roll be directed from the rear to
the front.

15. Fill the Rinse Solution 16. Connect the tubings with
Bottle with purified water and the correct bottles. See colours
the Washing Solution Bottle on bottles and tubings for guid-
with the appropriate Wash- ance.
ing Solution.
Place the two multilingual bio-
For preparation of the Wash- hazard labels on each side of
ing Solution, please read the the waste bottle.
Directions for Use in the
ImmunoCAP Washing Solu-
tion kit.

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Phadia 100 - User Manual Instrument Specification and Installation

17. A warning label in english

is placed below the Pipette
1
1

Arm. If required place a warn-

ing label with appropriate lan-
guage on top of the english
label.

18. Place warning labels with appropriate

language to the left of and on the right hand
side of the sample carousel compartment.

19. The instrument should

now be ready to use. WARNING! Do not use radio transmitters or
mobile telephones within a radius of 2 metres
from Phadia 100. The use of such devices close to
the instrument may impair the instrument's
performance.

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Instrument Specification and Installation Phadia 100 - User Manual

Parameter Set Up

It is possible to change the default settings for different parameters to adapt

Phadia 100 to your needs.

Date/Time

1. In Prepare Run mode press Phadia 100 Ver.3.0 14:10:17

6. 1.Prepare Run?

2. Press yes. Phadia 100 Ver.3.0 14:10:17

6.Install/Service?

3. In Install/Service mode 6.Install/Service

press 3. 1.Login/Logout?

4. In Date/Time mode press 6.Install/Service

yes. 3.Date/Time?

5. If the displayed year is 6.3.Date/Time

correct press enter. If you wish Year: 09
to change year type the year
you want and press enter.

6. If the displayed month is 6.3.Date/Time

correct press enter. If you wish Month: 1
to change month type the
month you want and press
enter.

7. If the displayed day is 6.3.Date/Time

correct press enter. If you wish Day: 31
to change day type the day you
want and press enter.

8. If the displayed hour is 6.3.Date/Time

correct press enter. If you wish Hour: 14
to change hour type the hour
you want and press enter.

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Phadia 100 - User Manual Instrument Specification and Installation

9. If the displayed minute is

correct press enter. If you wish
6.3.Date/Time
Minute: 10
1
1

to change minute type the

minute you want and press
enter.

Language

1. In Install/Service mode 6.Install/Service

press 4. 1.Login/Logout?

2. Press yes. 6.Install/Service

4.System parameters?

3. Press yes. 6.4.System parameters

1.Language?

4. Press no until the language 6.4.1.Language

you want appears, then press Language: ENGLISH?
yes.

5. Press no until the format 6.4.1.Language

you want appears, then press Date format: DAY-MONTH-YEAR?
yes.

6. Press no until the format 6.4.1.Language

you want appears, then press Time format: 24-HOUR?
yes.

7. Type the character you 6.4.1.Language

want for separator between the Time separator: :
hour and minute and press en-
ter. For more characters press
the shift key and key 0-9 at the
same time.

Default Method
It is possible to choose the method that Phadia 100 displays as a default method
in different functions.

1. In Install/Service mode 6.Install/Service

press 4. 1.Login/Logout?

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Instrument Specification and Installation Phadia 100 - User Manual

2. Press yes. 6.Install/Service

4.System parameters?

3. In System Parameters 6.4.System parameters

mode press 2. 1.Language?

4. Press yes. 6.4.System parameters

2.Default Method?

5. Press no until the method 6.4.2.Default Method

you want as default appears, Method: ImmunoCAP Specific IgE 0-100?
then press yes.

Set sIgE Method

The instrument can be set to use either ImmunoCAP Specific IgE 0-100 or
ImmunoCAP Specific IgE as sIgE method. At delivery ImmunoCAP Specific IgE
0-100 is set as default.

1. In Install/Service mode 6.Install/Service

press 4. 1.Login/Logout?

2. Press yes. 6.Install/Service

4.System parameters?

3. In System Parameters 6.4.System parameters

mode press 9. 1.Language?

4. Press yes. 6.4.System parameters

9.Set sIgE Method?

5. Press no until the sIgE 6.4.9.Set sIgE Method

method you want appears, then Method: ImmunoCAP Specific IgE 0-100?
press yes.
6.4.9.Set sIgE Method
Method: ImmunoCAP Specific IgE?

Contrast

1. In Install/Service mode 6.Install/Service

press 5. 1.Login/Logout?

2. Press yes. 6.Install/Service

5.Contrasts?

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Phadia 100 - User Manual Instrument Specification and Installation

3. Press yes. 6.5.Contrasts

1.Set LCD Contrast?
1
1

4. Change the LCD contrast SELECT LCD CONTRAST

by pressing the key below BRIGHTER DARKER
BRIGHTER or DARKER.
Press enter when the contrast
is set.

5. Press no. 6.5.Contrasts

1.Set LCD Contrast?

6. Press yes. 6.5.Contrasts

2.Set Printer Contrast?

7. Change the printer con- SELECT PRINTER CONTRAST

trast by pressing the key below BRIGHTER DARKER PRINT Contrast:5
BRIGHTER or DARKER. The
contrast can be set between 0-
9. Press the key below PRINT
if you want to make a printout
to check the choosen contrast.
Press enter when the contrast
is right.

NOTE! If you change the LCD contrast too much

is it impossible to read the text presented in the
window.

Set and Change Passwords

You find the settings and changing of passwords in the 6.1.Login/Logout menu.
Default Laboratory Password is "unicap". To change this password to a specific
one known only to authorized personnel, go to 6.Install/Service (as described
in the section Date/Time) and follow the description below.

1. In Install/Service mode 6.Install/Service

press yes. 1.Login/Logout?

2. In Login/Logout mode 6.1.Login/Logout

press 3. 1.Login?

3. Press yes. 6.1.Login/Logout

3.Change password?

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Instrument Specification and Installation Phadia 100 - User Manual

4. Type in the new password, 6.1.3.Change Password

then press enter. New password:_

5. Retype the new password, 6.1.3.Change Password

then press enter. Confirm password:_

6. The new password is set. 6.1.3.Change Password

NEW PASSWORD SET

Communication Parameters
To enter this menu you need access to the laboratory password. In most cases
you do not need to change the settings for the communication parameters, if you
connect a bar code reader you sometimes need to change the settings. Follow the
steps below when you set the parameters for the bar code reader. To connect a
barcode reader of USB type, please contact your local Phadia representative.

1. In Install/Service mode 6.Install/Service

press 7. 1.Login/Logout?

2. Press yes. 6.Install/Service

7.Communication parameters?

3. Press no until the com- 6.7.Communication parameters

munication port that you want Select Port: COM2?
to change parameters for is dis-
played.
Instruments equipped with USB ports:
Choose COM2 to connect a bar code reader to the RS-232 port.
Instruments equipped with a diskette drive:
Choose COM3 to connect a bar code reader to the RS-232 port.
Confirm with yes.

4. Press yes. 6.7.Communication parameters COM2

1.Baud rate?

5. Press no until the baud 6.7.1.Baud rate COM2

rate you want appears, then Baud rate: 9600?
press yes.

6. Press no. 6.7.Communication parameters COM2

1.Baud rate?

7. Press yes. 6.7.Communication parameters COM2

2.Data bits?

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Phadia 100 - User Manual Instrument Specification and Installation

8. Press no until the data bits

you want appear, then press
6.7.2.Data bits
Data bits: 8?
COM2
1
1

yes.

9. Press no. 6.7.Communication parameters COM2

2.Data bits?

10. Press yes. 6.7.Communication parameters COM2

3.Stop bits?

11. Press no until the stop bits 6.7.3.Stop bits COM2

you want appear, then press Stop bits: 1?
yes.

12. Press no. 6.7.Communication parameters COM2

3.Stop bits?

13. Press yes. 6.7.Communication parameters COM2

4.Parity?

14. Press no until the parity 6.7.4.Parity COM2

you want appears, then press Parity: NONE?
yes.

15. Press no. 6.7.Communication parameters COM2

4.Parity?

16. Press yes. 6.7.Communication parameters COM2

5.Port Usage?

17. Press no until BARCODE 6.7.5.Port Usage COM2

appears, then press yes. Select Usage for COMPORT: BARCODE?

Configure Phadia 100 for TCP/IP

When using IDM the IP address and the Port for IDM has to be set. To enter this
menu you need access to the laboratory password. Follow the steps below when
you set the IP address and Port.

1. In Install/Service mode 6.Install/Service

press 7. 1.Login/Logout?

2. Press yes. 6.Install/Service

7.Communication parameters?

3. Press no until 6 is dis- 6.7.Communication parameters COM2

played. 6.IDM TCP/IP Address?

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Instrument Specification and Installation Phadia 100 - User Manual

4. Press yes.
6.7.6.IDM TCP/IP Address
Enter Address:
5. Enter the TCP/IP Address,
6.7.6.IDM TCP/IP Address
then press Enter.
Enter Address:192.168.0.10

6. Press Enter to return to

the selection menu.

7. Press no until 7 is dis- 6.7.Communication parameters COM2

played. 7.IDM TCP/IP Port?

8. Press yes. 6.7.6.IDM TCP/IP Port

Enter Port:

9. Enter the TCP/IP Port (de- 6.7.6.IDM TCP/IP Port

fault port is 5004), then press Enter Port: 5004
Enter.

Configure computer name

When using more than one Phadia 100 in the same network, the computer name
has to be set. To enter this menu you need access to the laboratory password.
Follow the steps below when you set the computer name.

1. In Install/Service mode 6.7.Communication parameters COM2

press 8. 8.Computer name?

2. Press yes. 6.7.8.Computer

Computer name:

3. Enter the computer name 6.7.8.Computer

(in this example BARU1431), Computer name: BARU1431
then press Enter.

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Phadia 100 - User Manual Routine Assay Run

Chapter 2 - Routine Assay Run

This chapter describes the set ups and 2
the functions of a routine assay with
Phadia 100.

Menu Structure
Moving in Menus
2
2
2
To Enter Data 3

3
Select Alternatives 4
Messages 4
Error Messages 5
Status Information 5
Message Information 5

Instrument Panel 7

4
Panel 8

Menus 9
Verification of Instrument Performance 16
ImmunoCAP Specific IgE 0-100 16

5
ImmunoCAP Specific IgE 18
ImmunoCAP Total IgE 19
ImmunoCAP ECP and ImmunoCAP Tryptase 20
ImmunoCAP Specific IgG and ImmunoCAP Specific IgA 22
ImmunoCAP Specific IgG4 23
EliA IgG, EliA IgA, EliA Calprotectin and EliA IgM 25

6
Calculation of CV % values 26

Training Mode 29
Introduction 30
Principles of Operation 32
Workflow 32

Notes and Warnings 34

Calibration Curve Assay 36 13
Enter Request 38
Load and Start 42

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Routine Assay Run Phadia 100 - User Manual

Menu Structure

When you switch on the instrument normally "Phadia 100" will be displayed for
about one minute. For version 2.34 and lower, If the instrument has been in use
for a very long time without being switched off, it will take longer time before
it is ready for use. In some cases it might even take 10 or 20 minutes.
For Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the instruc-
tions displayed to safely shut down the instrument. Never switch the instrument
off and then promptly on again! Wait at least 10 seconds before switching it on
again.
When you switch the instrument on, the first menu to be displayed is the menu
that you worked with when the instrument was switched off. You return to
1.Prepare Run by pressing the mode key.
If you want to enter the Prepare Run mode, simply press the yes key. A sentence
with a question mark is answered with yes or no, otherwise you can press the
enter key to confirm and save the data.
To enter another menu item you can either press the no key or you can press a
number key to reach the level represented by that number. For example if you
want to reach the Quality Control mode, you can press the number 4 key.
If you are in a menu you want to leave, press the mode key. Note that in most
cases, when you use the mode key, changes done in the mode you leave will not
be saved. To save any changes press the enter key.
On the following pages the menu tree is described.

NOTE! Use the no and yes or a number key to

get to the menu item you want to work with.
Use the mode key to quit the mode you are in.
Note that changes done will not be saved.
The enter key will save the data you typed.

Moving in Menus

This is the first menu to be

Phadia 100 Ver.3.0 13:48:33
displayed on Phadia 100. In
1.Prepare Run?
this menu you find the version
number of the software in your
Phadia 100, the time and the
first menu item. You can an-
swer the question with yes or
no.

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Phadia 100 - User Manual Routine Assay Run

If you press no you will come to

Phadia 100 Ver.3.0 13:48:33
the next menu item (in this case 2.Abort Run?
2.Abort Run). You can also
select a key that represents the 2
number of the menu item you
want to select, in this
case 2.

If you press the yes key you

will enter the Prepare Run
Mode.
Phadia 100 Ver.3.0
1.Prepare Run?
13:48:33 2
In the Prepare Run mode you
can select between the menus
using yes, no or a number key.
1.Prepare Run
1.Enter Request? 3
To Enter Data

When there is an underline you

4
1.1.Enter Request [28]
can type a value. If you want to Enter Sample ID:_

5
enter a new value delete the old
value and then type the new.
The typed value is saved when
you press enter.

When you enter data you can use the following keys:
enter
+/-
shift + +/-
will save the data you entered
will display a minus
will display a plus
6
del will delete data one step at a time
shift + del will delete the whole line
will move cursor one step to the right
yes
13
no will move cursor one step to the left
shift + enter will display default value (when there is a default value)
mode will step up one menu level

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ccc

Routine Assay Run Phadia 100 - User Manual

Select Alternatives

In this case you can select an

alternative by pressing no and 3.2.2.Specific Run
Run: (23) 090522 11:05?
then yes on the option you
want. You can also enter the
sequence number using the
number keys.

When you select data you can use the following keys:
yes selects the displayed alternative
enter selects the displayed alternative
no displays the next alternative
shift + no displays previous alternative
1-9 displays the alternative represented by the typed number
shift + enter displays default value (when there is a default value) and is also
used for shipping
mode abort the selection by moving up one menu level

To select an alternative SELECT METHOD FOR CALIBRATORS

press the key that repre- sIgE tIgE ECP Tryp sIgG sIgA El-G El-A
sents the alternative you
want to select. In this case
Q W E R T Y U I O P
press R if you want to se-
lect ECP as the method for
calibrators.

In some cases the displayed alternatives are words that reach over two keys, in
this case any of the keys can be pressed for that alternative. If there are more than
8 alternatives you can press alt to see the rest of the alternatives.

Messages

If there is a message that re- 1.3.1.Load Reagents

mains on the display you can LOAD 2220 ul DEV SOL IN POS E
press enter to confirm or re-
move the message.

You can always use mode to leave the mode you are in and step up to the menu
above.
NOTE! mode will not save any entered data.

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Phadia 100 - User Manual Routine Assay Run

Error Messages

There are three different types 2

5.1.Add Method
of error messages that can be
E103: FILE NOT FOUND!
displayed. This is the type that
will remain on the display until

2
you press a key (any key).

This type is the abort or con-

4.3.1.Specific Calibrators
tinue type. Press yes or no to
E009: MEDIA WRITE-PROTECTED, ABORT?
continue.

The fatal error type has an E-

number and a double exclama-
4.5.3.Export Calibrators
E089: INTERNAL ERROR!!
3
tion mark. Please make a note
about the circumstances and

4
the error number, then turn the
instrument off. Contact your
local Phadia representative for
service.

For further information regarding error messages see chapter 12, Error Handling.

Status Information 5
PROCESS STATUS 02:10:33 34

6
The status key displays infor- Sample WASH ImmunoCAP 1-4
mation about the process tak-
ing place. The information can
be accessed at any time by press-
ing status.

The status information may also be displayed automatically to indicate a certain

status, e.g. when a process is finished.
The only keys available at status information is mode to return to the previous 13
display and message to go to the message information. The number in the
upper right corner refers to the assay number.

Message Information

64: FATAL #25.01 090516 18:45:23

The message key displays in- PIPETTE Z MOTOR BENT PIPETTE
formation about errors during
the process that is taking place.
The message information can
be accessed at any time by press-
ing message.

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Routine Assay Run Phadia 100 - User Manual

The message information may also be displayed automatically when an error

occurs.
At the message information you can step back in the list of previous errors by
pressing message. With no you can step forward again.
To exit message information press mode to return to previous display or press
status to go to the status information.

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12-3501-20/12
Press the
message key
Press the status to display the
Phadia 100 - User Manual

Lit when key to display message page Press the

temperature is the status page Press the lid with infor- paper feed key

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Lit when Lit when the within range, with informa- open key to mation about to feed paper
you use a instrument is otherwise Lit when tion about the open the errors during through the
PC remote. processing. flashing light. power is on. active process. processing lid. the process. printer.

temp
process
PC remote lid paper
open 7 8 9 feed

Q W T U I status message +/-

E R Y O P 4 5 6

J enter yes no
A S D F G H K L 1 2 3 enter

shift Z V N M space alt mode del

X C B 0 .

Press the Press the space Press the alt key to Press the enter You can Use the mode Use the del Press the
shift key for key when you change method in key to confirm answer a key to step up key to delete enter key
capital want spacing the mode where you a function or question with one menu level. the previous to confirm
letters and between enter tests. You also entered text. yes or no. character on a function
special characters on use the alt key to the display. or entered
characters the display. choose letters text.
underneath specific to your
number. language.

Page 2.7
Routine Assay Run

Instrument Panel

6
5
4
3
2

13
2
Routine Assay Run Phadia 100 - User Manual

Panel
The panel consist of the keyboard and the display.
The backlit display contains two rows with 40 characters in each row. The
keyboard contains 51 keys.
The printer is a 40/80 character width printer.
Besides the alphanumeric keys you also have some functional keys. The
functional keys are described on the pages before.
To the right of the display you have some LEDs for power, temperature,
processing and PC remote. If any of the LEDs is lit the function is activated.

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Phadia 100 - User Manual Routine Assay Run

Menus
2

1.Prepare Run
1.1.Enter Request
1.2.Print Lists 2
1.3.Load and Start
1.3.1.Load Samples
1.3.2.Load Reagents
1.3.3.Load ImmunoCAP/Load EliA Well
1.3.4.Start Process
3
1.4.Edit Request

4
1.4.1.Edit Sample ID
1.4.1.1.Change Sample ID
1.4.1.2.Change Test
1.4.1.3.Add Test
1.4.1.4.Delete Test
1.4.2.Delete Sample ID

5
1.4.3.Delete Calibrators
1.5.Load Old Run
1.6.ImmunoCAP<->PC
1.6.1.Import Run

6
1.6.2.Export Run

2.Abort Run
2.1.Abort Prepared Run
2.1.1.Delete All Request Data
2.1.2.Remove Single ImmunoCAP/Remove Single EliA Well 13
2.1.3.Remove All ImmunoCAP/Remove All EliA Wells
2.2.Abort Process

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Routine Assay Run Phadia 100 - User Manual

3.Data Evaluation
3.1.Print Patient Report
3.1.1.All Samples in a Run
3.1.2.Specific Sample
3.2.Print Laboratory Report
3.2.1.Summary of Runs
3.2.2.Specific Run
3.2.3.Specific Run, Select Calibrators
3.2.4.Specific Run, switch CC
3.2.5.Specific Run, disable CC
3.2.6.Specific Run, disable blank error
3.2.7.Specific Run, disable fatal error
3.3.Export Data
3.4.Import Data

4.Quality Control
4.1.Print Log
4.1.1.Quality control-log
4.1.2.Curve control-log
4.2.Edit Log
4.2.1.Quality control-log
4.2.2.Curve control-log
4.3.Print Calibrators
4.3.1.Specific Calibrators
4.4.Edit Calibrators
4.4.1.Set active Calibrators
4.4.2.Accept Calibrators
4.4.3.Edit Calibrator point
4.5.ImmunoCAP<->PC
4.5.1.Export Quality control-logs
4.5.2.Export Curve control-logs
4.5.3.Export Calibrators

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Phadia 100 - User Manual Routine Assay Run

5.Method Setup*
5.1.Add Method
2
5.2.Edit Method
5.2.1.General parameters
5.2.1.1.Name**

2
5.2.1.2.Abbreviated name**
5.2.1.3.Allow Monthly calibration**
5.2.1.4.Cal code on ImmunoCAP/EliA Well
5.2.1.5.Sequence number**
5.2.1.6.Method priority**
5.2.1.7.Diluent**

3
5.2.1.8.Diluent in pos. G
5.2.1.9.Action list number**
5.2.1.10.Reverse Calibrators**
5.2.1.11.Default Cut-off Concentration**
5.2.2.Reagents**
5.2.2.1.Volume**

4
5.2.2.2.Incubation time**
5.2.2.3.Identity**
5.2.3.Reference
5.2.3.1.Curve control
5.2.3.1.1.Add Curve ctrl**
5.2.3.1.2.Edit Curve ctrl

5
5.2.3.1.2.1.Status**
5.2.3.1.2.2.Identity**
5.2.3.1.2.3.Test name**
5.2.3.1.2.4.Replicate**
5.2.3.1.2.5.Concentration**
5.2.3.1.2.6.Expected s

6
5.2.3.1.2.7.Limit s Inner
5.2.3.1.2.8.Limit s Outer
5.2.3.1.2.9.Log start date
5.2.3.1.3.Delete Curve ctrl**
5.2.3.2.Calibrators
5.2.3.2.1.Test name**
5.2.3.2.2.Age until warning
5.2.3.2.3.Max. flagged time**
5.2.3.2.4.Max. reactivate time**
5.2.3.2.5.Max. bad replicates** 13
5.2.3.2.6.Low RU on zero-point**
5.2.3.2.7.Quotient Point
5.2.3.2.8.Add Point**
5.2.3.2.9.Edit Point**
5.2.3.2.10.Delete Point**
5.2.3.3.Blank**

* This menu can be reached if you are logged in with laboratory password.
** Cannot be edited for Phadia AB default methods.

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Routine Assay Run Phadia 100 - User Manual

5.2.4.Presentation**
5.2.4.1.X-axis**
5.2.4.1.1.Text**
5.2.4.1.2.Scale**
5.2.4.1.3.Unit**
5.2.4.2.Y-axis**
5.2.4.2.1.Text**
5.2.4.2.2.Scale**
5.2.4.2.3.Unit**
5.2.4.2.4.Fixed scale
5.2.5.Calculation**
5.2.5.1.Calculation type**
5.2.5.2.Normal Weight**
5.2.5.3.Predicted Variance A**
5.2.5.4.Predicted Variance B**
5.2.5.5.Robust Weight**
5.2.5.6.Min. Coeff. of Correlation**
5.2.5.7.Zero-point
5.2.5.8.Lowest concentration
5.2.6.Report Type
5.2.6.1.Cut-off
5.2.6.1.1.Text below reference
5.2.6.1.2.Text above reference
5.2.6.2.Reference curve
5.2.6.2.1.Concentration unit**
5.2.6.2.2.Text below lowest
5.2.6.2.3.Add Class border**
5.2.6.2.4.Edit Class border
5.2.6.2.5.Delete Class border**
5.2.6.2.6.Quantitative Below
5.2.6.2.7.Quantitative Above
5.2.6.2.8.Use Calc Quant Above
5.2.6.3.Cut-off 2 (or ASM class)
5.2.6.3.1.Text below lowest
5.2.6.3.2.Add Class border**
5.2.6.3.3.Edit Class border
5.2.6.3.4.Delete Class border**
5.2.6.4.Extra Reference classes
5.2.6.4.1.Text below lowest
5.2.6.4.2.Add Class border**
5.2.6.4.3.Edit Class border
5.2.6.4.4.Delete Class border**
5.2.6.5.Extra Cut-off 2 (or Extra ASM classes)
5.2.6.5.1.Text below lowest
5.2.6.5.2.Add Class border**
5.2.6.5.3.Edit Class border
5.2.6.5.4.Delete Class border**

** Cannot be edited for Phadia AB default methods.

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Phadia 100 - User Manual Routine Assay Run

5.2.7.Tests
5.2.7.1.Add Test
5.2.7.2.Edit Test
5.2.7.2.1.Test name 2
5.2.7.2.2.Full name
5.2.7.2.3.Replicate
5.2.7.2.4.Report concentration
5.2.7.2.5.Report class

2
5.2.7.2.6.Report cut-off
5.2.7.2.7.Report cut-off 2/Report ASM class
5.2.7.2.8.Report quotient
5.2.7.2.9.Concentration unit**
5.2.7.2.10.Concentration factor**
5.2.7.2.11.Highest concentration**

3
5.2.7.2.12.Decimals for conc <10**
5.2.7.2.13.Use Lot Specific Code**
5.2.7.2.14.Dilution factor
5.2.7.2.15.Dilution method
5.2.7.2.16.Diluent**
5.2.7.2.17.Cut-off concentration*
5.2.7.2.18.Emphasize on reports**

4
5.2.7.2.19.Quant Below undiluted
5.2.7.2.20.Quant Above undiluted
5.2.7.2.21.Quant Below diluted
5.2.7.2.22.Quant Above diluted
5.2.7.2.23.Diluent in pos. G
5.2.7.2.24.Quality Club Index (not used)
5.2.7.2.25.Lower detection limit
5.2.7.3.Delete Test
5.2.7.4.Change Report for All
5.2.8.Unknowns
5.2.8.1.Dilution method
5
5.2.8.2.Dilution factor

6
5.2.8.3.%CV limit**
5.2.9.Quality control
5.2.9.1.Add QC
5.2.9.2.Edit QC
5.2.9.2.1.Status
5.2.9.2.2.Identity
5.2.9.2.3.Test name
5.2.9.2.4.Replicate
5.2.9.2.5.%CV limit resp
5.2.9.2.6.Expected conc 13
5.2.9.2.7.Expected s
5.2.9.2.8.Limit s
5.2.9.2.9.Range minimum
5.2.9.2.10.Range maximum
5.2.9.2.11.Log start date
5.2.9.2.12.Lot number
5.2.9.2.13.Predilution factor
5.2.9.2.14.Instr.dilution factor
5.2.9.2.15.Type of QC
5.2.9.2.16.Order
5.2.9.3.Delete QC

** Cannot be edited for Phadia AB default methods.

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Routine Assay Run Phadia 100 - User Manual

5.3.Delete Method**
5.4.Print Method
5.4.1.Summary of Methods
5.4.2.Specific Method
5.4.3.All Methods
5.5.Export Method
5.5.1.Specific Method
5.5.2.All Methods
5.6.Import Method

6.Install/Service
6.1.Login/Logout
6.1.1.Login
6.1.2.Logout
6.1.3.Change Password
6.2.Test Panels
6.2.1.Add Test Panel
6.2.2.Edit Test Panel
6.2.2.1.Add Test
6.2.2.2.Delete Test
6.2.3.Delete Test Panel
6.2.4.Print Test Panel
6.2.4.1.Summary of Test Panel
6.2.4.2.Specific Test Panel
6.2.4.3.All Test Panels
6.3.Date/Time
6.4.System Parameters
6.4.1.Language
6.4.2.Default Method
6.4.3.Patient Report Options
6.4.3.1.Report Comments
6.4.3.2.Allow Tests from Several Runs
6.4.4.Laboratory Report Options
6.4.4.1.Include Calibration curve
6.4.4.2.Include Calibrator data
6.4.4.3.Unknown Data order
6.4.4.4.Number of Copies
6.4.4.5.Print Lot information
6.4.4.6.Print Action list
6.4.4.7.Print Error list
6.4.5.Operating Mode

* This menu can be reached if you are logged in with laboratory password.

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Phadia 100 - User Manual Routine Assay Run

6.4.8.External Printer Settings

6.4.9.Set sIgE Method
6.5.Contrasts 2
6.5.1.Set LCD Contrast
6.5.2.Set Printer Contrast
6.6.Article Management*
6.6.1.Add Article
6.6.2.Edit Article
6.6.3.Delete Article
2
6.7.Communication Parameters*

3
6.7.1.Baud rate
6.7.2.Data bits
6.7.3.Stop bits
6.7.4.Parity
6.7.5.Port Usage

4
6.7.6.IDM TCP/IP Address
6.7.7.IDM TCP/IP Port
6.7.8.Computer
6.9.Maintenance
6.9.1.Daily Maintenance
6.9.2.Monthly Maintenance
6.9.3.FluoroC
6.9.3.1.FluoroC Run
5
6.9.3.2.FluoroC Log
6.9.4.System Rinse
6.9.5.Run Blanks
6.9.6.Run Selftest
6.9.7.Weekly Maintenance
6
6.9.8.Semiannual Maintenance
6.10.Training-Mode
6.11.Export Debug Files
6.11.1.Export Debug Log Files 13
6.11.2.Export Debug Run Files
6.11.3.Create Instrument Event Log
6.12.Upgrade
6.13.Shutdown

* This menu can be reached if you are logged in with laboratory password.

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Routine Assay Run Phadia 100 - User Manual

Verification of Instrument Performance

To verify the instrument performance before using the instrument in routine runs,
please follow the instructions below.
A number of laboratories have accreditation for running specified tests. To
receive and obtain this accreditation proof regarding the quality of the results is
requested. Below find a suggestion on how to test the performance of different
methods in Phadia100.
This protocol also can be used just to check the performance of a specific method
or Phadia100 instrument. Examples are given below.
Other methods can use a suiting protocol as one of the examples below, for
example to verify Specific IgA the protocol for Specific IgG can be used and to
verify Tryptase the protocol for ECP can be used.
The following general reagents are required:
Development Kit
Washing Solution

ImmunoCAP Specific IgE 0-100

Reagents for ImmunoCAP Specific IgE 0-100

ImmunoCAP Specific IgE

ImmunoCAP Specific IgE Calibrators 0-100
ImmunoCAP Specific IgE Control
ImmunoCAP Specific IgE Negative Control
Anti-IgE ImmunoCAP
ImmunoCAP Allergen d1
ImmunoCAP Allergen e1
ImmunoCAP Allergen t3
or other allergens included in ImmunoCAP Specific IgE Control;
d1, e1, g6, m6, t3, w1, or ImmunoCAP Specific IgE f1 Control

Protocol for acceptance of ImmunoCAP Specific IgE 0-100

Run 1:
• Full calibration curve (0, 0.35, 0.7, 3.5, 17.5, 100 kU IgE/l, in duplicates this
is set as default in the software when a calibration curve is requested).
• ImmunoCAP Specific IgE Control tested for three allergens in duplicate
(define controls according to Chapter 4, Assay Run Editing Functions)

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Phadia 100 - User Manual Routine Assay Run

• ImmunoCAP Specific IgE Negative Control tested for the same three
allergens as above, in duplicate
• At least six individual patient samples in duplicate, any allergens
2

Criteria for acceptance of Run 1:

• The instrument software accepts the curve
• The mean values for ImmunoCAP Specific IgE Control is within given range
• ImmunoCAP Specific IgE Negative Control will give results below 0.35 kUA/l
with allergen ImmunoCAP for all replicates
2
Run 2 and 3:
• Curve controls 1 and 2 (single replicate, as default)
• ImmunoCAP Specific IgE Control tested for three allergens in duplicate.
3
• ImmunoCAP Specific IgE Negative Control tested for the same three

4
allergens as above, in duplicate
• At least six individual patient samples (same as in the first run) in duplicate,
same allergens as in the first run

Criteria for acceptance of Runs 2 and 3:

• Curve controls are within range, the run is accepted by the instrument
software
• The mean values for ImmunoCAP Specific IgE Control are within given
5
ranges

6
• ImmunoCAP Specific IgE Negative Control will give results below 0.35 kUA/l
with allergen ImmunoCAP for all replicates

Criteria for total acceptance of ImmunoCAP Specific IgE 0-100:

• Criteria for Runs 1 through 3 are fulfilled
• Pooled coefficients of variation (CV) within runs are < 6% for ImmunoCAP
Specific IgE Control and patient samples 13
• Total CV (%) for ImmunoCAP Specific IgE Control and patient samples are
< 10%

Printouts of laboratory reports and patient reports can be done.

Calculate the CV as described in Calculation of CV % values.
If all the criteria for total acceptance are fulfilled, results can be used for clinical
routine.
When method is accepted, remember to set replicate to 1 as default for the
unknown samples and to set replicate of controls as desired.
In order to maintain the instrument's performance, please follow instructions in
chapter 11, Maintenance.

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Routine Assay Run Phadia 100 - User Manual

ImmunoCAP Specific IgE

Reagents for ImmunoCAP Specific IgE

ImmunoCAP Specific IgE

ImmunoCAP Specific IgE Calibrators
ImmunoCAP Specific IgE Control
ImmunoCAP Specific IgE Negative Control
Anti-IgE ImmunoCAP
ImmunoCAP Allergen d1
ImmunoCAP Allergen e1
ImmunoCAP Allergen t3
or other allergens included in ImmunoCAP Specific IgE Control;
d1, e1, g6, m6, t3, w1, or ImmunoCAP Specific IgE f1 Control

Protocol for acceptance of ImmunoCAP Specific IgE

Run 1:
• Full calibration curve (0.35, 0.7, 3.5, 17.5, 50, 100 kU IgE/l, in duplicates
this is set as default in the software when a calibration curve is requested).
• ImmunoCAP Specific IgE Control tested for three allergens in duplicate
(define controls according to Chapter 4, Assay Run Editing Functions)
• ImmunoCAP Specific IgE Negative Control tested for the same three
allergens as above, in duplicate
• At least six individual patient samples in duplicate, any allergens

Criteria for acceptance of Run 1:

• The instrument software accepts the curve
• The mean values for ImmunoCAP Specific IgE Control is within given range
• ImmunoCAP Specific IgE Negative Control is negative for all replicates

Run 2 and 3:
• Curve controls 1 and 2 (single replicate, as default)
• ImmunoCAP Specific IgE Control tested for three allergens in duplicate.
• ImmunoCAP Specific IgE Negative Control tested for the same three
allergens as above, in duplicate
• At least six individual patient samples (same as in the first run) in duplicate,
same allergens as in the first run

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Phadia 100 - User Manual Routine Assay Run

Criteria for acceptance of Runs 2 and 3:

• Curve controls are within range, the run is accepted by the instrument
software
2
• The mean values for ImmunoCAP Specific IgE Control are within given
ranges
• ImmunoCAP Specific IgE Negative Control is negative for all replicates

Criteria for total acceptance of ImmunoCAP Specific IgE:

• Criteria for Runs 1 through 3 are fulfilled
2
• Pooled coefficients of variation (CV) within runs are < 6% for ImmunoCAP

3
Specific IgE Control and patient samples
• Total CV (%) for ImmunoCAP Specific IgE Control and patient samples are
< 10%

Printouts of laboratory reports and patient reports can be done.

Calculate the CV as described in Calculation of CV % values.
If all the criteria for total acceptance are fulfilled, results can be used for clinical
routine.
4
When method is accepted, remember to set replicate to 1 as default for the

5
unknown samples and to set replicate of controls as desired.
In order to maintain the instrument's performance, please follow instructions
in chapter 11, Maintenance.

6
ImmunoCAP Total IgE

Reagents for ImmunoCAP Total IgE

ImmunoCAP Total IgE

ImmunoCAP Total IgE Calibrators
ImmunoCAP Total IgE Control LMH
13

Protocol for acceptance of ImmunoCAP Total IgE

Run 1:
• Full calibration curve (2, 10, 50, 200, 1000, 5000 kU IgE/l, in duplicates -
this is set as default in the software when a calibration curve is requested)
• ImmunoCAP Total IgE Controls, three levels in duplicate (define controls
according to Chapter 4, Assay Run Editing Functions)
• At least six individual patient samples in duplicate

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Routine Assay Run Phadia 100 - User Manual

Criteria for acceptance of Run 1:

• The instrument software accepts the curve
• The mean values for ImmunoCAP Total IgE Controls are within given ranges

Run 2 and 3:
• Curve controls 1 and 2 (single replicate, as default)
• ImmunoCAP Total IgE Controls, three levels in duplicate
• At least six individual patient samples in duplicate

Criteria for acceptance of Runs 2 and 3:

• Curve controls are within given ranges, the run is accepted by the instrument
software
• The mean values for ImmunoCAP Total IgE Controls are within given
ranges

Criteria for total acceptance of ImmunoCAP Total IgE:

• Criteria for Runs 1 through 3 are fulfilled
• Pooled coefficients of variation (CV) within assay runs are < 6% for
ImmunoCAP Total IgE Controls and patient samples
• Total CV (%) for ImmunoCAP Total IgE Control and patient samples are
< 10%

Printouts of laboratory reports and patient reports can be done.

Calculate the CV as described in Calculation of CV % values.
If all the criteria for total acceptance are fulfilled, results can be used for clinical
routine.
When method is accepted, remember to set replicate to 1 as default for the
unknown samples and to set replicate of controls as desired.
In order to maintain the instrument in good shape, please follow instructions in
chapter 11, Maintenance.

ImmunoCAP ECP and ImmunoCAP Tryptase

Reagents for ImmunoCAP ECP

ImmunoCAP ECP
ImmunoCAP ECP Calibrators
ImmunoCAP ECP Control

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Phadia 100 - User Manual Routine Assay Run

Protocol for acceptance of ImmunoCAP ECP and ImmunoCAP

Tryptase

Below you see an example for ImmunoCAP ECP. This is applicable also for 2
ImmunoCAP Tryptase. The reagents differ depending on selected method.
Run 1:
• Full calibration curve (2, 5, 15, 100, 200 µg ECP/l, in duplicates - this is set
as default in the software when a calibration curve is requested)
• ImmunoCAP ECP Control in four replicates (define controls according to
Chapter 4, Assay Run Editing Functions)
2
• At least six individual patient samples in duplicate

Criteria for acceptance of Run 1:

• The instrument software accepts the curve
3
• The mean value for ImmunoCAP ECP Control is within given range

Run 2 and 3:
• Curve control 1 (two replicates, as default)
4
• ImmunoCAP ECP Control in four replicates

5
• At least six individual patient samples in duplicate

Criteria for acceptance of Runs 2 and 3:

• Curve control is within range, the run is accepted by the instrument software

6
• The mean value for ImmunoCAP ECP Control is within given range

Criteria for total acceptance of ImmunoCAP ECP:

• Criteria for Runs 1 through 3 are fulfilled
• Pooled coefficient of variation (CV) within assay runs are < 6% for
ImmunoCAP ECP Control and patient samples
• Total CV (%) for ImmunoCAP ECP Control and patient samples are < 10% 13

Printouts of laboratory reports and patient reports can be done.

Calculate the CV as described in Calculation of CV % values.
If all the criteria for total acceptance are fulfilled results can be used for clinical
routine.
When method is accepted, remember to set replicate to 1 as default for the
unknown samples and to set replicate of controls as desired.
In order to maintain the instrument in good shape, please follow instructions in
chapter 11, Maintenance.

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Routine Assay Run Phadia 100 - User Manual

ImmunoCAP Specific IgG and

ImmunoCAP Specific IgA

Reagents for ImmunoCAP Specific IgG

ImmunoCAP Specific IgG

IgA/IgG Calibrator ImmunoCAP
ImmunoCAP Specific IgG Calibrators
ImmunoCAP Specific IgG Curve Controls
ImmunoCAP Gliadin
ImmunoCAP i1
ImmunoCAP Gliadin Control IgA/IgG LMH
ImmunoCAP Specific IgG Control LMH
ImmunoCAP Specific IgG/IgG4 Control L
ImmunoCAP Specific IgG/IgG4 i1 Control H

Protocol for acceptance of ImmunoCAP Specific IgG and

ImmunoCAP Specific IgA

Below you see an example for ImmunoCAP Specific IgG. This is applicable also
for ImmunoCAP Specific IgA. The reagents differ depending on selected
method.
Run 1:
• Full calibration curve (0.02, 0.04, 0.1, 0.3, 1.0, 2.0 mg/l, in duplicates - this
is set as default in the software when a calibration curve is requested)
• All controls, tested in duplicate
• At least six individual patient samples in duplicate

Critieria for acceptance of Run 1:

• The instrument software accepts the curve
• The mean values for the controls are within given ranges

Run 2 and 3:
• Curve controls 1 and 2 (single replicate, as default)
• All controls, tested in duplicate
• At least six individual patient samples (same as in the first run) in duplicate

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Phadia 100 - User Manual Routine Assay Run

Criteria for acceptance of Runs 2 and 3:

• Curve controls are within range, the run is accepted by the instrument
software
2
• The mean values for the controls are within given ranges

Criteria for total acceptance of ImmunoCAP Specific IgG:

• Criteria for Runs 1 through 3 are fulfilled
• Pooled coefficients of variation (CV) within runs are < 8% for controls and
patient samples
2
• Total CV (%) for controls and positive patient samples are < 12%

Printouts of laboratory reports and patient reports can be done.

Calculate the CV as described in Calculation of CV % values.
3
If all the criteria for total acceptance are fulfilled, results can be used for clinical

4
routine.
When method is accepted, remember to set replicate to 1 as default for the
unknown samples and to set replicate of controls as desired.
In order to maintain the instrument's performance, please follow instructions in
chapter 11, Maintenance.

ImmunoCAP Specific IgG4

5
6
Reagents for ImmunoCAP Specific IgG4

ImmunoCAP Specific IgG4

IgA/IgG Calibrator ImmunoCAP
ImmunoCAP IgG4 Calibrators
ImmunoCAP Specific IgG4 Curve Controls
13
ImmunoCAP i1
ImmunoCAP Specific IgG Control LMH
ImmunoCAP Specific IgG/IgG4 Control L
ImmunoCAP Specific IgG/IgG4 i1 Control H

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Routine Assay Run Phadia 100 - User Manual

Protocol for acceptance of ImmunoCAP Specific IgG4

Run 1:
• Full calibration curve (0, 3, 15, 35, 120, 300 µg/l, in duplicates - this is set
as default in the software when a calibration curve is requested)
• All controls, tested in duplicate
• At least six individual patient samples in duplicate

Critieria for acceptance of Run 1:

• The instrument software accepts the curve
• The mean values for the controls are within given ranges

Run 2 and 3:
• Curve controls 1 and 2 (single replicate, as default)
• All controls, tested in duplicate
• At least six individual patient samples (same as in the first run) in duplicate

Criteria for acceptance of Runs 2 and 3:

• Curve controls are within range, the run is accepted by the instrument
software
• The mean values for the controls are within given ranges

Criteria for total acceptance of ImmunoCAP Specific IgG4:

• Criteria for Runs 1 through 3 are fulfilled
• Pooled coefficients of variation (CV) within runs are < 8% for controls and
patient samples
• Total CV (%) for controls and positive patient samples are < 12%

Printouts of laboratory reports and patient reports can be done.

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Phadia 100 - User Manual Routine Assay Run

EliA IgG, EliA IgA, EliA IgM and EliA

Calprotectin
2
Reagents for EliA IgG

2
EliA IgG Conjugate
EliA Diluent
EliA ANA Control
EliA IgG Calibrators

3
EliA dsDNA Wells
In addition six individual patient samples per method are required.

Protocol for acceptance of EliA IgG, EliA IgA and EliA IgM

4
Below you see an example for EliA IgG. This is applicable also for EliA IgA and
EliA IgM. The reagents differ depending on selected method.
Run 1:
• Full calibration curve (0, 4, 10, 20, 100, 600 µg/l, in duplicates - this is set
as default in the software when a calibration curve is requested)
• EliA ANA Control, two levels in duplicate on EliA dsDNA Wells (define
controls according to Chapter 4, Assay Run Editing Functions)
• At least six individual patient samples in duplicate on EliA dsDNA Wells
5
6
Criteria for acceptance of Run 1:
• The instrument software accepts the curve
• The mean values for EliA ANA Control are within given range

Run 2 and 3:
• Curve control 1 (two replicates as default)
13
• EliA ANA Control, two level tested in duplicate on EliA dsDNA Wells.
• At least six individual patient samples (same as in the first run) in duplicate
on EliA dsDNA Wells

Criteria for acceptance of Runs 2 and 3:

• Curve control is within range, the run is accepted by the instrument software
• The mean values for EliA ANA Control are within given ranges

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Routine Assay Run Phadia 100 - User Manual

Criteria for total acceptance of EliA IgG:

• Criteria for Runs 1 through 3 are fulfilled
• Pooled coefficients of variation (CV) within runs are < 8% for EliA ANA
Positive Control and positive patient samples
• Total CV (%) for EliA ANA Positive Control and positive patient samples are
< 12%

Printouts of laboratory reports and patient reports can be done.

Calculation of CV % values
For two and four (ImmunoCAP ECP Control/ImmunoCAP Tryptase Control)
replicates in each of three runs the calculations are performed according to
Tables 1 and 2 respectively.
The obtained concentrations are entered into the cells within the double frame.
The mean and variance for each column (run) are calculated as follows:

n
_
Mean = x = 1
n ∑x i
i=1

n
_
∑(x - x )
1
Variance = i
2
n-1
i=1

where
xi = cell value
n = number of values
The mean and variance of the run means are calculated as above and entered as
MTot and VMean. The mean of the variances is also calculated and entered as VWithin.
The coefficients of variation are then obtained according to the formulas below
the tables.
Tables 3 and 4 are examples of typical results.
For your own calculations of CV (%), use the link to the calculation form on the
Start Up page on the Phadia 100 cd.

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Phadia 100 - User Manual Routine Assay Run

Forms for calculation

Calculation of CV (%) with two replicates in each of three runs.

2
Table 1

Replicate Run 1 Run 2 Run 3 MTot VMean

VWithin

Mean
1
2 2
Variance

Total CV (%) within runs = 100 √ Within

V
3
MTot

4
Total CV (%) = 100 √VMean + 0.5xVWithin
MTot

Calculation of CV (%) with four replicates in each of three runs

Table 2

Replicate Run 1 Run 2 Run 3 MTot

VWithin
VMean 5
1

6
2
3
4
Mean

Variance

Total CV (%) within runs = 100 √ Within

V
MTot

Total CV (%) = 100 √VMean + 0.75xVWithin

MTot

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Routine Assay Run Phadia 100 - User Manual

Examples of calculation

Calculation of CV (%) with two replicates in each of three runs:

Table 3

Replicate Run 1 Run 2 Run 3 MTot VMean

VWithin

1 2.87 3.43 2.98

2 3.01 3.27 3.20
Mean 2.94 3.35 3.09 3.13 0.0430
Variance 0.0098 0.0128 0.0242 0.0156

CV (%) within runs = 100 √VWithin = 4.0 %

M Tot

Total CV (%) = 100 √VMean + 0.5xVWithin = 7.2 %

MTot

Calculation of CV (%) with four replicates in each of three runs:

Table 4

Replicate Run 1 Run 2 Run 3 MTot VMean

VWithin

1 15.2 14.8 16.4

2 15.9 15.1 16.5
3 15.1 15.9 16.2
4 15.8 15.4 17.3
Mean 15.5 15.3 16.6 15.8 0.49
Variance 0.17 0.22 0.23 0.21

CV (%) within runs = 100 √VWithin = 2.9 %

MTot

Total CV (%)= 100 √ Mean +

V 0.75xVWithin
= 5.1%
MTot

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Phadia 100 - User Manual Routine Assay Run

Training Mode
2

When you unpacked the instrument as described earlier in this chapter, you can
use the Training Mode to learn more about the instrument. You find the Training
Mode if you select the menu 6.10.Training-Mode on your display. As long as you
are in this mode you can use Phadia 100 without changing anything. This is a
copy of the entire software and nothing that you do in this software mode will
affect the actual instrument software. You can practice without risking to change
2
anything in the actual software. In this mode there are asterisks after the menu

3
numbers to remind you that you are working in the Training Mode. Remember
to exit the Training Mode when you are done.

4
5
6
13

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Routine Assay Run Phadia 100 - User Manual

Introduction

Phadia Laboratory Systems consists of the Phadia 100 instrument with software
for immunodiagnostic laboratory testing and of ImmunoCAPreagents.
Phadia 100 instrument is designed to handle all the steps from request to result.
It distributes samples, ImmunoCAP and reagents and processes all the steps from
incubation, washing, measuring to calculation and printing of results.
To run a routine assay you start by entering the request, then move on to load
and start the run. The instrument will distribute ImmunoCAP/EliA Wells,
samples and reagents. The instrument also performs incubation, washing and
measuring, all according to the method used.

ImmunoCAP Total IgE, ImmunoCAP ECP and

ImmunoCAP Tryptase methods require the cali-
bration code of the stored calibration curve to
correspond with the conjugate and ImmunoCAP.
The other methods require the calibration code
of the stored calibration curve to correspond
with the conjugate.

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Phadia 100 - User Manual Routine Assay Run

Monthly Calibration

You can choose to run a calibration curve in your run or use a stored calibration
curve. The stored calibration curve is valid for the specific calibration code for 2
a maximum time of 28 days as long as the curve controls are within the limits.
The calibration code for the stored calibration curve has to correlate with the
code of the components.

Curve Controls

Calculation against stored calibration curves requires the use of reagents with
2
the same calibration code. In these runs curve controls are included to check that
the actual run is on the same response level as the stored curve. Limits for the
response of the curve controls are defined in the software. For more information
see chapter 7, Monthly Calibration.
3
Process

Requests, reagents, samples and ImmunoCAP/EliA Wells are loaded manually.

The process is then started and takes about 2.5 hours. A laboratory report is
automatically printed when the process is ended. Maintenance has to be done
according to the guideline in chapter 11, Maintenance.
4
Barcode reader

A barcode reader can be connected to be of help when entering requests,

reagents, ImmunoCAP and samples. The barcode reader is mandatory when
5
entering EliA Wells. For further specification, see chapter 14, Accessories.

Phadia Information Data Manager (IDM)

The Phadia Information Data Manager, or IDM, is the operator software of the
6
Phadia instrument. The operator software runs on a Microsoft Windows-based
PC. You can connect up to 5 instruments to the system PC.
The IDM provides features for certain tasks included in the in vitro allergy and
autoimmunity testing procedure. Using the IDM you can import request data 13
from, or export request data to, a connected mainframe computer, create
requests and assay runs, and retrieve test results from the instrument(s).
The IDM also includes features for managing result data, printouts, and Quality
Club™, as well as a login/logout function and facilities for changing IDM
settings and parameters.

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Routine Assay Run Phadia 100 - User Manual

Principles of Operation
The instrument is controlled from the panel at the front of the instrument.
You load the reagents and samples in the Sample Carousel to the left of the
instrument. Positions are marked to simplify the loading of the reagents.
You load ImmunoCAP/EliA Well carriers at the top of the middle section of the
instrument.
Each required reagent, sample or ImmunoCAP/EliA Well will be prompted on
the display in the Load and Start mode. You load it and confirm the step with
the instrument.
The Washing Solution, Rinse Solution and Waste bottles are placed just behind
the carousel to the left of the instrument.
The instrument is also equipped with a printer and a diskette drive. You find the
printer to the right in the middle section and the diskette drive at the right on
top of the instrument.

Workflow

Enter Request

Go to Prepare Run mode and select 1.1.Enter Request. Type cal and choose
method. If not all methods are displayed, you can find them if you press alt. If
a calibration curve is not requested, type the sample identities, choose test
(allergen/autoimmunity antigen) respectively method. Curve Controls will
automatically be included in the assay setup, if calibrators are not run.
Controls defined in the method as Active will automatically be added to the
assay setup when the first patient request is entered for that method.

Print List

Select 1.2.Print Lists to print out a wanted list:

• request list to check if request is correct
• consumption list to see the required volume of reagents and samples
• distribution list to know where samples and reagents are placed, in case you
load the wrong sample or reagent and want to change manually.
• ImmunoCAP/EliA Wells are not marked with short names so that manual
placement of ImmunoCAP/EliA Wells is not recommended.
For further and detailed information of all printouts, see chapter 10, Printouts.

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Phadia 100 - User Manual Routine Assay Run

Load and Start

Select 1.3.Load and Start; the software will guide you through loading of
reagents and samples. Be sure to load the correct reagent/sample in the correct 2
place in the sample carousel. Inspect the surface of all reagents/samples for air
bubbles or film. In case of air bubbles or film, pop them away with a clean pin.
Be extremely careful not to cross-contaminate reagents.

2
Dead volumes of reagents are included in the volume asked for by the software.
Dead volumes of samples are, however, not included. This is because dead
volumes vary a lot between sample tubes. For example of dead volumes of
sample tubes, please see Chapter3, Reagent and Sample Handling. Be sure to
load enough sample.

3
Check the volume of the Washing and Rinse Solution. One liter is needed for
each solution. The prepared Washing Solution is stable for one week when
stored in room temperature. Check also that the tube connections are firmly
pressed down into the bottles. Press down until there is a clicking sound.

4
WARNING! Washing Solution may cause
sensitization by skin contact. Wear protective
gloves!

When loading ImmunoCAP/EliA Well, be sure to load the correct allergen/

5
antibody.
Select 1.3.4.Start Process. The instrument will start the process as soon as the
right temperature level is reached (37ºC ± 0.5ºC). The process takes about 2.5
hours and a laboratory report will automatically be printed when the process
is ended.

Maintenance

Maintenance has to be done in order to keep the instrument in good condition

6
and secure the instrument performance. Please read chapter 11, Maintenance.

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Routine Assay Run Phadia 100 - User Manual

Notes and Warnings

When operating Phadia 100 please take the following notes and warnings into
consideration:

NOTE! Phadia 100 must only be connected to a

grounded power outlet (protective ground).

NOTE! Before closing the processing lid, check

that the wash rake is not in its top or bottom
position, otherwise it might break something
inside. The wash rake can be moved manually
and should be set in a middle position.

NOTE! The ImmunoCAP Holder Disc is fragile

and should be handled as glass. Replace if
dropped on floor.

NOTE! Make sure that the volume of the sample

in each tube is sufficient for the required amount
to be withdrawn. The dead volume of the sample
tubes must be added to the sample volumes
specified on the Consumption List. Insufficent
sample volume or empty sample tubes might
lead to unreliable results.

NOTE! When running ImmunoCAP Specific IgA,

ImmunoCAP Specific IgG or ImmunoCAP Spe-
cific IgG4 with a full sample carousel, 1 l of
Washing Solution is not enough. Fill up the
bottle with Washing Solution.

NOTE! Do not unscrew the cap from the bottles

if the tubings are still connected. This can cause
problems with insufficient distribution of Wash-
ing and Rinse Solution due to twisted and stuck
tubings inside the instrument.

NOTE! For stability reasons it is important to

store ImmunoCAP and EliA Wells at 2° C to 8° C.
EliA Wells are moisture sensitive and must be
stored with desiccant.

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Phadia 100 - User Manual Routine Assay Run

NOTE! When the process is done, remember to

empty the waste bottle and the ImmunoCAP
waste container. Wipe the area under the sample
carousel and the area under the ImmunoCAP
2
carousel with a damp cloth.

2
WARNING! Washing Solution may cause
sensitization by skin contact. Wear protective
gloves!

WARNING! Waste bottle, ImmunoCAP waste

container and process chamber may be
contaminated by potentially infectious,
biohazard material - take appropriate actions.
Wear protective gloves! 3
WARNING! Phadia 100 pipettes human body

4
fluids, which might be infected. When servicing
and maintaining Phadia 100, take precautions to
avoid direct contact with parts that have been in
contact with samples. Wear protective gloves!

WARNING! Phadia 100 processing chamber is

exposed to human body fluids, which might be
infected. When servicing and maintaining Phadia
100, take precautions to avoid direct contact
5
with parts that have been in contact with

6
samples. Wear protective gloves! For disposal
follow local procedures for biohazard material.

WARNING! Phadia 100 waste bottle collects

waste liquids containing human body fluids, which
might be infected. When emptying and cleaning
the waste bottle, take precautions to avoid
direct contact with the liquids. Wear protective 13
gloves!

WARNING! Do not use radio transmitters or

mobile telephones within a radius of 2 metres
from Phadia 100. The use of such devices close to
the instrument may impair the instrument's
performance.

BIOHAZARD! Two multilingual labels with this

message are included in the shipment. Place the
labels on each side of the waste bottle.

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Routine Assay Run Phadia 100 - User Manual

Calibration Curve Assay

A calibration curve must be performed after 28 days or when a new lot number
of conjugate or ImmunoCAP (for Total IgE, ECP, Tryptase) is introduced. For
more information see chapter 7, Monthly Calibration.

1. In Prepare Run mode press Phadia 100 Ver.3.0 13:48:33

yes. 1.Prepare Run?

2. Press yes. If the Enter 1.Prepare Run

Request mode does not turn up 1.Enter Request?
on your display, press 1.

Warnings that may prevent entering

PC NOT READY
Instrument is set in PC remote mode, but the PC is not set in "communication
mode".
REMOTE REQUESTS ENTERED
The currently prepared run has been prepared on a remote PC and cannot be
edited in the instrument.
RUN IS LOADED
Loading of reagents, ImmunoCAP/EliA Wells or samples has already been
started and the run cannot be changed.
NO ROOM FOR MORE REQUESTS
The currently prepared run occupies all ImmunoCAP/EliA Wells, sample or
reagent positions.

3. Type cal (instead of the 1.1.Enter Request [48]

patient identity) at the Enter Enter Sample ID:cal
Sample ID and press enter.

4. Select the method you SELECT METHOD FOR CALIBRATORS

want by pressing the key sIgE tIgE ECP Tryp sIgG sIgA El-G El-A
below the method name.
There is a pointer below
Q W E R T Y U I O P
each method name that di-
rects you to the right key. If
more than eight methods are
defined in the software press alt
to display more methods.

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Phadia 100 - User Manual Routine Assay Run

Messages that can occur

CALIBRATION CURVE ALREADY EXISTS. RUN NEW? 2

There are already calibrators for the method you selected. If you press yes you
will add new calibrators to the run. If you press no, the existing ones will be used.

2
CALIBRATORS ALREADY ADDED
You have already added calibrators to this method and run.
TOO MANY METHODS AT SAME TIME
The number of methods possible to enter was exceeded. Maximal number of
methods that can be entered in one run is four (4).

3
NOT ENOUGH ROOM FOR CALIBRATORS
There is not enough ImmunoCAP/EliA Well or sample positions left to add the
calibrators to the run.
METHOD NOT COMPATIBLE

4
El-G method is not compatible with methods using ImmunoCAP.

5. When you have selected 1.1.Enter Request [6]

the method you want, there will CALIBRATORS ADDED TO RUN

5
be a message (which will be
shown for just a few seconds)
telling you that the calibrators
are added to the run.

6. Now you can continue

6
1.1.Enter Request [36]
adding sample identities. If you Enter Sample ID:_
want to enter patient samples
go to Load and Start.

7. To return to previous Phadia 100 Ver.3.0 13:48:33

mode press mode or enter. 1.Prepare Run?
Then you will return to the Pre-
pare Run mode. 13
For information how to print a Specific Run with selected calibrators, see
chapter 10, Printouts.

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Routine Assay Run Phadia 100 - User Manual

Enter Request

You enter a request by starting with the sample identity and then adding the test
identities. You can enter the identities from the keyboard or with a barcode
reader. If a calibration curve is to be included in the run, you specify the
calibration curve as described in the Calibration Curve Assay.
You will be prompted to select whether or not Quality Controls should be
included with the specified method if Quality Controls are given the status
Manual. Quality Controls with status Active will be added automatically to the
assay run. Status of Quality Controls are set in 5.2.9.1.Add QC.
The method used is the one selected as default (menu level 6.4.2.Default
Method) when the program was installed. You can change the method by
pressing alt when entering the test identities.
If you enter more tests then there are available positions, you will be asked if you
want to skip the whole sample identity or just the tests left for that sample
identity. You can also leave the Enter Request mode before all the positions are
filled by pressing enter. If you press mode, the request will not be saved.
The number of ImmunoCAP/EliA Wells that can be entered in one assay run is
48. This is also the maximum number of samples that can be placed in the sample
carousel.

1. Press yes. Phadia 100 Ver.3.0 14:10:17

1.Prepare Run?

2. Press yes. 1.Prepare Run

1.Enter Request?

Warnings that may prevent entering

REMOTE REQUESTS ENTERED

The currently prepared run has been prepared on a remote PC and cannot be
edited in the instrument.
RUN IS LOADED
Loading of reagents, ImmunoCAP/EliA Wells or samples has already been
started and the run cannot be changed.
PC NOT READY
Instrument is set in PC remote mode, but the PC is not set in "communication
mode".
NO ROOM FOR MORE REQUESTS
The currently prepared run occupies all ImmunoCAP/EliA Wells, sample or
reagent positions.

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Phadia 100 - User Manual Routine Assay Run

3. Type the sample ID (up to 1.1.Enter Request [48]

16 characters) and press enter. Enter Sample ID:_
If you use a barcode reader, the
sample ID is entered when you 2
read the barcode.

To add a calibration curve type cal instead.

2
To add Quality Control type qc (if status MANUAL is chosen in the method).

4. Enter the test names or 1234 (sIgE)Test:_ [48]

test panel names by typing them
one at a time and press enter to

3
confirm each test name.
If you use a barcode reader, 1234 (sIgE)Test:f1_ [45]
each test is entered when you t3, w1, g6
read the barcode.

To change method press alt and choose the method. Then select the tests you

4
want for this method.
If you want to change replicates or dilution factor, please see chapter 4, Assay
Run Editing Functions.

5. To save the entered tests 1234 (sIgE)Test:_ [44]

5
for the sample identity, press t3, w1, g6, f1
enter again.

NOTE! If you press the mode key before enter, you will lose the information
entered to the sample identity.

6
6. Now you can enter the 1.1.Enter Request [44]
next sample identity or leave Enter Sample ID:_
this mode.

If you want to return to Enter Request mode, press mode or enter.

When you entered all the samples for the request you may continue processing
the assay run. Then go to 1.3.Load and Start.

13
7. When no positions are left 1235 (sIgE)Test:f3 [0]
in the instrument, the next en- NO TEST POS. LEFT. Skip Sample ID?
tered test will induce a ques-
tion.

You can skip the sample identity or just the test that cannot be positioned. Press
yes if you want to skip the sample ID. All the tests entered for this sample ID
will be deleted.
Press no if you do not want to skip the sample ID.

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Routine Assay Run Phadia 100 - User Manual

Messages that can occur

NO ACTIVE CALIBRATORS, ADD TO RUN?

There is no stored calibration curve for the method.
NO TEST POS LEFT, Skip Sample ID?
There is no position left for ImmunoCAP/EliA Well. If you press yes the sample
identity will be removed.
NO TEST POS LEFT, Skip Test?
There is no position left for ImmunoCAP/EliA Well. If you press yes the test will
be removed.
NO TEST POS LEFT, Skip Panel?
There are not enough ImmunoCAP/EliA Well positions left. If you press yes the
test panel will be removed.
NO SAMPLE POS LEFT, Skip Sample ID?
There is no position left for sample. If you press yes the sample identity will be
removed.
NO SAMPLE POS LEFT, Skip Test?
There is no position left for sample. If you press yes the test will be removed.
NO SAMPLE POS LEFT, Skip Panel?
There is no position left for sample. If you press yes the test panel will be
removed.
PREDILUTED 1:10?
Press yes if the sample is prediluted ten times (this example).
INSTRUMENT DILUTION 1:10?
Press yes if the test is to be diluted ten times (this example). The dilution is
carried out by the instrument.
TEST ALREADY ENTERED
The test name has already been entered for the sample.
TOO MANY METHODS AT THE SAME TIME
The number of methods possible to enter was exceeded. Maximal number of
methods that can be entered in one run is four (4). If ImmunoCAP and EliA are
entered the message METHOD NOT COMPATIBLE should show up.
ENTERED TEST DOES NOT EXIST
The entered test name is not defined in the currently available methods.
WRONG BAR-CODE IDENTITY
Bar-code was read, but could not be recognized as a test type. Check that you
have not read the EAN code instead of the article bar-code.
METHOD NOT COMPATIBLE
El-G method is not compatible with methods using ImmunoCAP.

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Phadia 100 - User Manual Routine Assay Run

INSTRUMENT DILUTION TOO HIGH

Instrument dilution exceeds 100.
DILUTION GREATER THAN 100. CONTINUE 2
Instrument dilution and pre.dilution exceeds 100.

8. Press yes if you want to

skip the test. You can enter this
test in another assay.
1235 (sIgE)Test:f3
NO TEST POS. LEFT. Skip Test?
[0]
2
If you press no you will return
to the Skip Sample ID display.

9. Do not forget to press

enter before you leave this
1235
t3, w1, w5, w6
(sIgE)Test:_ [0] 3
mode.

4
When you have entered all the tests for the request, you may want to continue
processing the assay run. The Load and Start procedure is described on the
following pages.

5
6
13

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Routine Assay Run Phadia 100 - User Manual

Load and Start

These steps will include the loading of system liquids, reagents, samples,
ImmunoCAP/EliA Wells and finally starting up the run. There will be an
amount and a position given for each component. In some cases you have to
enter the calibration code of the conjugate and ImmunoCAP/EliA Wells. Each
step is confirmed with enter.

NOTE! Make sure that the volume of the sample

in each tube is sufficient for the required amount
to be withdrawn. The dead volume of the sample
tubes must be added to the sample volumes
specified on the Consumption List.

The dead volume varies between tubes, please see chapter 3.

For all the other reagents (excluding calibrators, controls and CC) the dead
volume is already included in the calculated volume.
If you use the barcode reader, you have to follow the loading order as described
below. The instrument will recognize the component when reading the barcode.
If you are loading the components manually, please be sure to load the correct
component in the correct place. The instrument will not warn you if the
component is not the correct one.
NOTE! Check for air bubbles or film on the surface of the reagents/samples. If
there are air bubbles or film, pinch them away. Otherwise the pipette sensor will
not detect the surface properly.
Good laboratory practice dictates that every precaution must be taken to avoid
evaporation and contamination. Therefore it is recommended to remove and
recap the QC vials from the instrument as soon as the pipetting of samples are
finished. For EliA the QC vials from Phadia AB are single use and should be left
in the instrument during the run.
When the run is processed the result will automatically be printed.

1. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17

press yes. 1.Prepare Run?

2. In Enter Request mode 1.Prepare Run

press 3. 1.Enter Request?

3. Press yes. 1.Prepare Run

3.Load and Start?

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Phadia 100 - User Manual Routine Assay Run

Warnings that may prevent entering

RUN IS NOT PREPARED 2

There is no currently prepared run.
PROCESS IS RUNNING

2
There is an assay run being processed. You may prepare a new run, but you
cannot load and start.

4. Press yes to load the

3
1.3.Load and Start
samples. 1.Load Samples?

Remove the caps on the reagents/samples before placing them in the Sample
Carousel.
Make sure that there is enough amount to be withdrawn.

4
Check for air bubbles or film on the surface of the reagents/samples. If there are
air bubbles or film, pinch them away. Otherwise the pipette sensor will not
detect the surface properly.

5. Check that the Washing, 1.3.1.Load Samples

5
Rinse and Waste bottles are WASH/RINSE/WASTE OK?
loaded. Press yes to confirm
this step.

WARNING! Washing Solution may cause

sensitization by skin contact. Wear protective

6
gloves!

Make sure the volume is enough and that the tube connection is pressed down
until you hear the clicking sound.

NOTE! When running ImmunoCAP Specific IgA,

ImmunoCAP Specific IgG or ImmunoCAP Specific 13
IgG4 with a full sample carousel, 1 l of Washing
Solution is not enough. Fill up the bottle with
Washing Solution.

Empty the ImmunoCAP Waste Container.

WARNING! Waste bottle, ImmunoCAP waste

container and process chamber may be
contaminated by potentially infectious,
biohazard material - take appropriate actions.
Wear protective gloves!

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Routine Assay Run Phadia 100 - User Manual

Messages that can occur

WASH SOLUTION LOT NUMBER REGISTRERED

You can use the barcode reader to register the lot number for Washing Solution.

6. Add all the required 1.3.1.Load Samples

samples. Press enter until all LOAD 120 ul SOI IN POS 4
solutions are loaded.

7. Add all the required con- 1.3.1.Load Samples LOT:AWT44

trols. Press enter until all con- LOAD 120 ul SIGE Ctrl Neg IN POS 5
trols are loaded.

Messages that can occur

LOT NUMBER NOT DEFINED IN METHOD

The lot number on the control vial does not correspond with the lot number in
the method. It is possible to add the new lot number manually by pressing the
shift and enter keys at the same time. A display will pop up where you can enter
the lot number and the limits for the lot. See Directions for Use.

Warnings that may prevent entering

LOAD ALL SAMPLES FIRST

To prevent contamination.
LOAD ALL QC FIRST
To prevent contamination.
LOAD ALL CALIBRATORS FIRST
To prevent contamination.
LOAD ALL CURVE CONTROLS FIRST
To prevent contamination.

8. Press yes to load the re- 1.3.Load and Start

agents. 2.Load Reagents?

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Phadia 100 - User Manual Routine Assay Run

9. Check the calibration 1.3.2.Load Reagents Cal Code:1A_

code of the conjugate and load LOAD 1800 ul sIgE-CONJ IN POS A
the conjugate in the instrument.
You find the calibration code 2
on the bottle. Type the calibra-
Calibration
tion code if it is not displayed code
automatically. Press enter to

2
confirm this step.

Messages that can occur

NOT THE ACTIVE CALIBRATORS, CONTINUE?

The entered calibration code is not the active code, but previously stored
calibration curve of the entered code exists and can be used for evaluation. You
3
will be prompted to type the calibration code again. It is possible to continue this

4
run by pressing yes or no.
NO CALIBRATORS AVAILABLE, PRESS ENTER
There are no stored calibrators of the entered code. No result is going to be
calculated. You will be prompted to type the calibration code again. However,
it is possible to continue this run and run calibrators with this code later by
pressing the shift and enter keys at the same time. The result of this run can then
be calculated against that curve.
CALIBRATORS FLAGGED, PRESS ENTER
The active calibrators of this calibration code are marked flagged. Press enter
5
to continue.

10. Add all the required re-

agents (e.g.Development Solu-
1.3.2.Load Reagents
LOAD 1500 ul DEV SOL IN POS E
6
tion, Stop Solution) in the given
positions. Press enter until all
solutions are loaded.

Warnings that may prevent entering

LOAD REAGENTS FIRST

To prevent contamination.
NO ImmunoCAP TO LOAD
All ImmunoCAP for this run has already been loaded.
NO EliA WELL TO LOAD
All EliA Wells for this run have already been loaded.

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Routine Assay Run Phadia 100 - User Manual

11. Press yes to start loading

1.3.Load and Start
ImmunoCAP/EliA Wells. 3.Load ImmunoCAP/EliA Well?

12. Press enter to start a

1.3.3.Load ImmunoCAP/EliA Well
blank check. PRESS ENTER TO START A BLANK CHECK

If a blank error occurs, se chapter 12, Error Handling.

Messages that can occur

WASH/RINSE CHECK NOT OK

For corrective actions see Action list.
WASH/RINSE HAVE BEEN MIXED
For corrective actions see Action list.

13. After the blank check is 1.3.3.Load ImmunoCAP/EliA Well

finished start loading LOAD 12 sIgE a_IgE
ImmunoCAP/EliA Wells.

Place the required ImmunoCAP/EliA Well carrier in position. Assure yourself

that you are loading the correct ImmunoCAP/EliA Well. The instrument will
distribute the ImmunoCAP/EliA Well to the correct position.

14. Type the Lot Specific 1.3.3.Load EliA Well Code:_

Code that is found on the label LOAD 12 El-G Gcal
on the EliA Well foil bag and
on the label on the EliA Well
Carrier. Press enter to confirm
the Lot Specific Code.

Messages that can occur

WRONG LOT SPECIFIC CODE

Wrong code entered.
USE DEFAULT LOT SPECIFIC CODE?
By pressing shift and enter or by pressing enter without entering a code, this
question is shown.
LOT SPECIFIC CODE CORRECT?
If correct press yes. If no, you have to select a tube with the same code as the
calibrators. Press enter to confirm the Lot Specific Code.

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Phadia 100 - User Manual Routine Assay Run

LOT SPECIFIC CODE NOT EQUAL

Present Lot Specific Code is not the same as the code used for the calibrators.
2

15. When all ImmunoCAP/ 1.3.3.Load ImmunoCAP/EliA Well

EliA Wells are loaded, remove ALL LOADED. REMOVE CARRIER. PRESS ENTER

2
the carrier. A message tells you
that everything is loaded. Press
enter to confirm this step.

16. Press yes to be able to 1.3.Load and Start

3
start processing the assay run. 4.Start Process?
If you press no you will return
to the Load Reagents mode.

17. Normally this step does 1.3.4.Start Process

4
not occur. Only the service PRESS ENTER TO START A VIAL CHECK
technican can activate a vial
check. Press enter to start it.

A message occurs that the pro- 1.3.4.Start Process

cess has started. PROCESS STARTED

If the vial check is ok, continue with step 19, otherwise with step 18.
5
6
Warnings that may prevent entering

LOAD IS NOT COMPLETED

Before the run can be started, reagents, samples and ImmunoCAP/EliA Well
must be loaded.
PRESSURE TOO LOW (1200 hPa)
The system pressure is too low. The system pressure has to be at a certain level
in order for the system to produce reliable results. 1200 is the actual pressure 13
in hPa.
WAITING FOR TEMPERATURE
Before the run can be started, incubation temperature has to reach the correct
level. The run will automatically start when the right temperature is reached.
POSITIONING...
This message will appear when the Sample Carousel is moving to a new position.
DISPENSING...
This message will appear when the instrument is dispensing ImmunoCAP/EliA
Well.

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Routine Assay Run Phadia 100 - User Manual

EXPIRY DATE PASSED, CONTINUE?

This question will appear on the display if bar-code is read on a reagent if the
expiry date is passed. Press yes to use anyway or no to use another reagent.
THIS REAGENT IS NOT REQUESTED
This message will appear if bar-code is read on a reagent not requested for this
run.
THIS SAMPLE IS NOT REQUESTED
This message will appear if bar-code is read on a sample not requested for this run.
THIS ImmunoCAP IS NOT REQUESTED
This message will appear if bar-code is read on an ImmunoCAP carrier not
requested for this run.
THIS EliA WELL IS NOT REQUESTED
This message will appear if bar-code is read on an EliA Well tube not requested
for this run.
REMOVE EMPTY CARRIER
The ImmunoCAP/EliA Well carrier is empty, but more ImmunoCAP/Elia Well
of this type is required.
SAMPLE CAROUSEL COVER IS NOT PRESENT
Put the Sample Carousel Cover in position.
PROCESSING LID IS NOT CLOSED
Close the Processing Lid.
PROCESSING LID IS NOT LOCKED
Make sure that the Processing Lid is closed properly and that nothing is blocking
the lid.
WRONG BAR-CODE IDENTITY
This message will appear if bar-code is read on something other than reagent,
sample or ImmunoCAP. Check that you have not read the EAN code instead of
the article bar-code.
WRONG CALIBRATION CODE
This message will appear if bar-code is read on a ImmunoCAP carrier with
wrong calibration code. Find the ImmunoCAP Carrier or run a new calibration
curve.
REMOVE CARRIER
This message will appear when to remove ImmunoCAP/EliA Well Carrier.
CHECK CAPS ON VIALS
Check that there are no caps left on vials.
ALL LOADED. REMOVE CARRIER
All ImmunoCAP are loaded. Remove the ImmunoCAP/EliA Well Carrier.
BLANK CHECK ERROR
For corrective actions see Action list.

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Phadia 100 - User Manual Routine Assay Run

DAILY MAINTENANCE NOT PERFORMED

Perform Daily Maintenance.
WEEKLY MAINTENANCE NOT PERFORMED 2
Perform Weekly Maintenance.
MONTHLY MAINTENANCE NOT PERFORMED

2
Perform Monthly Maintenance.
TEMPERATURE SENSORS DIFFER
For corrective actions see Action list.

18. To start the process press

enter. As soon as the tempera-
ture has reached 37ºC ± 0.5ºC
the instrument will start the
1.3.4.Start Process
PRESS ENTER TO START PROCESS 3
process.
1.3.4.Start Process

4
A message tells you that the
PROCESS STARTED
process has started.

19. If there were calibrators added to the run, you will get a message about the
status of the calibration. If status is OK, the calibration curve is stored and

5
available for use in routine runs. If status is NOT OK, the calibration curve is
stored but not available for use in routine runs.

20. When the run is processed, PROCESS COMPLETED

there will be a message telling EMPTY AND CLEAN INSTRUMENT

6
you that the process is com-
pleted and a report is printed.

21. Empty Waste bottle and ImmunoCAP waste container after each run.

WARNING! Waste bottle, ImmunoCAP waste

container and process chamber may be con- 13
taminated by potentially infectious, biohazard
material - take appropriate actions. Wear pro-
tective gloves!

22. Daily maintenance has to be performed at the end of the day. See
chapter 11, Maintenance, for further instructions.

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Routine Assay Run Phadia 100 - User Manual

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Phadia 100 - User Manual Reagent and Sample Handling

Chapter 3 - Reagent and Sample Handling

This chapter describes reagent and
sample handling, the use of different
tubes and dilutions
3

Reagent Handling, General 2

Reagent Handling, ImmunoCAP Specific IgA, ImmunoCAP Specific IgG,
ImmunoCAP Specific IgG4, EliA IgA, EliA IgG and EliA IgM 4
Recommendations regarding the performance 4

Dead Volumes for Different Tubes 7

Instrument Dilutions and Type of Samples 9

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Reagent and Sample Handling Phadia 100 - User Manual

Reagent Handling, General

General and specific Calibrators, Curve Controls, Conjugate, Quality

reagents Control, Development Solution, Stop Solution,
FluoroC and Diluent are reagents for the Phadia
100 methods. The ones used in the Phadia
instrument can be divided into method specific
reagents and general reagents. General reagents
are Development Solution, Stop Solution and
Washing Solution. The reagents are specified in
the Directions for Use provided with the reagent
kit.

Securing sample Make sure that the sample volume is sufficient,

including the sample tube dead volume.
volume
Temperature In order to get reliable results the reagents need
to have room temperature before loading into
the instrument.

Evaporation Good laboratory practice dictates that every

precaution must be taken to avoid evaporation
and contamination to guarantee reliable results.
Try to minimize the time period between
uncapping the reagents and starting the run.
Recap the reagents as soon the assay run is
finished. Use Sample Carousel Cover to minimize
evaporation.
NOTE! The quality control samples has to be
recapped and removed from the instrument as
soon as the pipetting of samples are finished and
the serum incubation is started. This is not valid
for EliA controls as they are single use vials.
Leave them in the instrument during the run and
discard them afterwards.

Contamination It is important to make sure that the correct cap

is screwed to the corresponding vial or bottle.
Do not touch the threads of the cap and the vial
or bottle. Development Solution is sensitive to
contamination by conjugate. ImmunoCAP
Specific IgA, ImmunoCAP Specific IgG,
ImmunoCAP Specific IgG4, EliA IgA, EliA IgG
and EliA IgM conjugate are sensitive to
contamination by patient samples, controls and
calibrators.

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Phadia 100 - User Manual Reagent and Sample Handling

Pooling In general it is not recommended to pool

reagents. Conjugates can be pooled once, but
only with another conjugate having the same
lot number and only from a new vial to an old
vial. Make sure to use the vial with the pooled
material only once and to discard the vial after
performed assay. Calibrators, Curve Controls, 3
FluoroC and EliA controls are dispensed in
single-dose vials. Always throw the vials away
after one determination. Single-dose vials are
not to be pooled.

Air bubbles, film It is important to pop air bubbles or film on the

and fibrin clots surface of reagents and samples, use a disposable
pipette tip to avoid contamination. If you notice
fibrin clots on the sample, remove them with a
disposable pipette tip to avoid contamination.
Make sure to change pipette tip between each
vial/tube.

Mix-up Use distribution list to verify that reagents and

samples are placed in correct position in the
sample carousel.

Securing reagent Use the consumption list to verify that necessary

volumes volume of reagents are available. Always make
1 liter Washing Solution. Use FluoroC bottle
only once, the same for calibrators, curve
controls and EliA controls.

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Reagent and Sample Handling Phadia 100 - User Manual

Reagent Handling, ImmunoCAP Specific IgA,

ImmunoCAP Specific IgG, ImmunoCAP
Specific IgG4, EliA IgA, EliA IgG and EliA
IgM

Recommendations regarding the

performance
Since high levels of IgG, IgA and IgM are common in many sources that can be
found in the surrounding, like in sputum, human skin flakes etc, a correct
handling of ImmunoCAP IgA, ImmunoCAP IgG, ImmunoCAP IgG4, EliA IgA,
EliA IgG and EliA IgM reagents becomes very important to avoid contamination
and to get reliable results. Some general points to be aware of, when handling
reagents, can be found in this chapter.
ImmunoCAP Specific IgG, ImmunoCAP Specific IgG4, EliA IgA, EliA IgG and
EliA IgM conjugates, calibrators and curve controls are very sensitive to
contamination from IgA, IgG, IgM and IgG4 in patient samples, due to the large
amount of IgA, IgG, IgM and IgG4 in human sera. We know from our
investigations that only 0.01 µl of a serum sample added to the conjugate vial
is enough to make an increase of the response level, which will lead to a non-
accepted calibration curve.
It is also very important that the instrument is well maintained according to the
maintenance procedures in Chapter 11 in Phadia 100 User Manual.

Things to be aware of before and after an assay

• Perform a Daily Rinse before each assay.

• Use the Consumption list to make sure that there are enough volumes of
reagents loaded. Always make sure that there is one liter of both Washing
Solution, prepared according to the DfU, and Rinse Solution added to the
bottles.
• Check tubing connections to the Washing Solution and Rinse Solution
bottles. The O-rings shall be lubricated regularly according to the
Monthly Maintenance. The screw caps of the bottles should be properly
tightened before the tubings are connected, this will secure that the
tubings are not twisted.
• In general it is not recommended to pool reagents. Conjugates can be
pooled once, but only with another conjugate having the same lot
number and only from a new vial to an old vial. Make sure to use the vial
with the pooled material only once and to discard the vial after performed
assay.
• Do not use the conjugate vial for more than four assay runs per vial.

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Phadia 100 - User Manual Reagent and Sample Handling

• For ImmunoCAP Specific IgA, ImmunoCAP Specific IgG and ImmunoCAP

Specific IgG4 assays: To avoid evaporation and contamination, it is
recommended to recap the QC vials before removing them from the
instrument. This can be done as soon as the pipetting of samples is finished
and the sample incubation is started. For EliA IgA, EliA IgG and EliA IgM
the QC samples are single dose and shall be discarded after the assay.
• After an assay, unload samples and reagents carefully in the following
3
order: Stop Solution, Development Solution, Conjugate, QC samples
and finally samples. Calibrators and curve controls are single dose and
shall be discarded after the assay.
• Perform a Daily Maintenance procedure immediately after each assay.

Points of importance when loading reagents and samples to

an assay run

• The software will guide you through loading of samples and reagents. Be
sure to load samples and reagents in the correct order and in the correct
place in the Sample Carousel.
• Avoid handling and mixing samples close to the instrument, reagents and
other components needed for an assay.
• When mixing samples it is enough to turn the tubes upside down a couple
of times, this also reduces the risk for bubbles in the vials.
• Do not remove the caps of the sample tubes close to the instrument.
• If needed, use a disposable pipette tip to pop air bubbles or film on the
surface of samples. Make sure to change tips between each vial. Perform
this step before loading the reagents into the sample carousel.
• Do not keep the calibrator-, curve control- or conjugate vials open close
to the instrument when loading patient samples.
• Do not use the same disposable gloves when loading samples and the rest
of the reagents.
• To reduce the risk for contamination when loading reagents, unscrew
caps on vials and bottles, place vials and bottles into the sample carousel
and finally, remove the caps. If needed, use a disposable pipette tip to pop
air bubbles or film on the surface of the reagents. Make sure to change
tips between each vial. Perform this step before loading the reagents into
the sample carousel.
• Avoid touching the threads of the caps or vials. Store caps in order to
avoid contamination and mix-ups.

Actions to take when problems occur

• Do a thorough cleaning of the instrument by performing Monthly

Maintenance, see chapter 11 in Phadia 100 User Manual. When performing
Monthly Maintenance, it is very important to clean the Washing- and
Rinse Solution bottles and the Elution Wells Disc thoroughly to get rid of
all the Maintenance Solution. Please note that Monthly Maintenance is

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Reagent and Sample Handling Phadia 100 - User Manual

performed as a corrective action according to the action list when having

problems with the IgG, IgA and IgM assays.
• For the next assay run, use a new bottle of conjugate. In the case when the
message: Reagent blank is too high occurs, use a new Development
Solution bottle as well.
• Clean Pipette tip with purified water or Maintenance Solution, followed
by 70% ethanol.
• If needed, exchange the Elution Wells Disc.

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Phadia 100 - User Manual Reagent and Sample Handling

Dead Volumes for Different Tubes

Dead volumes vary a lot between tubes. Here are some examples of tubes and 3
their dead volumes. If your tubes are not within these examples, look at the inner
and outer diameter and height and see the approximate dead volume.
It is very important to know the dead volume of the tubes used. Phadia 100 will
prompt you by the software to place a specific volume of the samples into the
sample carousel. The dead volume is not included in this volume, since it differs
so much between different tubes. If there is just a small volume of the sample, take
the dead volume into consideration.
NOTE! Only tubes with outer diameters between 10 to 16 mm can be used in
Phadia 100. Inner diameter must not be less than 9 mm. Tubes with heights
between 36 to 100 mm can be used.
For tubes with a cap hanging on, the cap must be cut off. Otherwise it will be in
the way of the pipette, creating pipette errors.
On the next page you find a table showing tubes tested for dead volumes on
Phadia 100.

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Reagent and Sample Handling Phadia 100 - User Manual

Brand Inner diameter Outer diameter Height Comment Dead volume

(mm) (mm) (mm) (µl)

Source unknown 9 11 36 gl, f 100

Sarstedt 9 10 40 pl, f 100
Sarstedt 9 11 45 pl, cp 100
Sarstedt 9 11 55 gl 100
Note! Cap must be cut off 10 11 38 pl, c 400
Ellerman 10 12 58 pl 100
Source unknown 9 11 70 pl 100
Venoject® 11 12 75 gl 100
Source unknown 10 12 70 pl 100
Source unknown 11 12 74 gl 100
Source unknown 11 12 75 pl 100
Greiner Vacuette® 11 13 75 pl 100
Sarstedt Monovette® 14 15.5 56 pl, f 200
Source unknown 12 13.5 80 pl 100
It. part. 11 12 86 pl 100
It. part. 14.5 16 100 pl 100
Nalgene® 10 11 83 pl, cp 100
Corning® 11 13 39 pl 100
Venoject® 8,5 10 65 gl 100
ACS 180 12 14 100 pl, c 100
Au. 13 14 96 pl 100
Greiner 139101 13 15 50 pl 200
Greiner 125101 11 13 100 pl 100
Greiner 103101 9 10 40 pl 100
Greiner 160101 14 16 100 pl 100

Comment description: Source unknown, these tube brands have not been
identified.
c = conical bottom
cp = small conical point at bottom
f = flat-bottomed
gl = glass
pl = plastic

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Phadia 100 - User Manual Reagent and Sample Handling

Instrument Dilutions and Type of Sample

Instrument dilutions with higher dilution factor than 10 are made in Diameter 3
two steps and require an empty tube - dilution tube- to make the first approximately
step of the dilution in (dilution 1:10). Higher dilution than 1:10 will 10 mm
reduce the sample loading capacity of the instrument. Since every
sample requires two tubes (sample tube and dilution tube) in the sample
carousel.
The tube must have a round bottom and the inner diameter should be
approximately 10 mm. A round bottom is needed in order to have as
little dead volume as possible.
The tubes must be of Ellerman type, plastic laboratory tubes. Ellerman
tubes (10x58 mm) can be ordered from Phadia AB, article number 12-
2450-01.
NOTE! No tubes with double bottom can be used due to risk of bent
pipette.
Instrument dilutions also requires a Diluent. Please see the Directions
for used regarding the choice of diluent. If predilution is selected the
dilution factor can be 1 - 1000. If instrument dilution is selected the
dilution factor can be 1, 2, 5, 10, 20, 50 or 100.
All samples have a dilution factor defined. The concentration will be multiplied
with the dilution factor and presented on the lab report.

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Reagent and Sample Handling Phadia 100 - User Manual

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Phadia 100 - User Manual Assay Run Editing Functions

Chapter 4 - Assay Run Editing Functions

This chapter describes how to select, add,
change and delete a prepared assay run

Edit Request 2 4
Change Dilution for Sample 3
Change Replicate or Dilution for Test 4
Change Sample ID
Delete Sample ID
Delete Calibrators
5
7
8
3
Select New Method 9
Select Quality Control Manually
Change Test
Add Test
10
11
15
4
Delete Test 18
Add QC
Edit QC
Set status
20
25
26
5
Identity 26
Test name 27

6
Replicate 27
Coefficient of variance limit response 28
Expected concentration 28
Expected standard deviation 29
Limit s 30
Range minimum 31
Range maximum 31
Log start date 32
Lot number 32
Predilution factor 33
Instrument dilution factor 33
Type of Quality Control 33
Order 34

Change QC with new Lot 35

Skip ImmunoCAP/EliA Well Loading 36
Load Old Run 37
Abort Prepared Run 39
Delete All Request Data 40
Remove Single ImmunoCAP/EliA Well 41
Remove All ImmunoCAP/EliA Well 43
Abort Process 44

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Assay Run Editing Functions Phadia 100 - User Manual

Edit Request

In Edit Request mode you can change sample identity, delete sample identity,
change test name, add test name, delete test name and delete calibrators from
a prepared assay run.

1. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17

press yes. 1.Prepare Run?

2. In Enter Request mode 1.Prepare Run

press 4. 1.Enter Request?

3. In Edit Request mode 1.Prepare Run

press yes. 4.Edit Request?

Warnings that may prevent entering

REMOTE REQUESTS ENTERED

The currently prepared run has been prepared on a remote PC and cannot be
edited in the instrument.
RUN IS LOADED
Loading of reagents, ImmunoCAP or samples has already been started. This run
cannot be changed.
RUN IS NOT PREPARED
There is no prepared run to edit.

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Phadia 100 - User Manual Assay Run Editing Functions

Change Dilution for Sample

The following steps describes how you change the replicate and dilution for a
sample when you are in Enter Request in the Prepare Run mode.

1. You can change the dilu- 4

1.1.Enter Request [24]
tion factor for a sample by typ- Enter Sample ID:3627_
ing the sample identity and then
pressing shift and enter keys

3
at the same time. In this case all
tests on this sample will be di-
luted.

2. Press yes if you want to

4
1.1.Enter Request [24]
add a prediluted sample, other- Sample Dilution:PREDILUTED?
wise press no. If yes go to step
4.

If predilution is selected the dilution factor can be 1-1000.

3. Press yes if you want the

instrument to perform the dilu-
tion, otherwise no.
1.1.Enter Request
Sample Dilution:INSTRUMENT DILUTION?
[24]
5
If you select instrument dilution the dilution factor can only be 1, 2, 5, 10, 20,
50 or 100.

4. Type the dilution factor

and press enter.
1.1.Enter Request
Enter Dilution Factor:1_
[24] 6
5. Enter the test names or 3627 (sIgE) Test:_ [24]
test panel names by typing them
one at a time and press enter to
confirm each test name.

6. To save the entered tests 3627 (sIgE) Test:f1_ [21]

for the sample identity, press t3, w1, g6
enter one more time.

Regarding dilutions, see also chapter 3, Reagent and Sample Handling and the
corresponding Directions for Use.

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Assay Run Editing Functions Phadia 100 - User Manual

Change Replicate or Dilution for Test

When you are entering a request you can change the dilution factor for a sample
being run in the Specific IgE, Specific IgA, Specific IgG, EliA IgA, EliA IgG or
EliA IgM method by pressing the shift and enter when you have typed the test
name. For a sample being run in Total IgE, ECP or Tryptase methods change
of dilution factor has to be done in 1.4.Edit Request. If the sample is prediluted
you can select a factor between 1 and 1000. The instrument dilution can only
be set to factor 1, 2, 5, 10, 20, 50 or 100.
When you are entering a request you can change the number of replicates and
the dilution for one or several tests within a sample identity.
The following steps describe how you change the replicate and dilution factor
for a test when you are in Enter Request in the Prepare Run mode.

1. Type the sample identiy 1.1.Enter Request [17]

and enter. Enter Sample ID:3627_

2. Type the test name and 3627 (sIgE)Test:f1 [17]

press then shift and enter at
the same time.

3. Type the replicate num- 3627 (sIgE)Test:f1 [17]

ber and press enter. Enter Replicate number:1
If you do not want to change
the replicate number, press only
enter.

4. Press yes if you want to 3627 (sIgE)Test:f1 [17]

add a prediluted sample for Test Dilution:PREDILUTED?
this test, otherwise press no.
If you press yes go to step 6.

5. Press yes if you want the 3627 (sIgE)Test:f1 [17]

instrument to perform the di- Test Dilution:INSTRUMENT DILUTION?
lution, otherwise press no.

6. Type the dilution factor 3627 (sIgE)Test:f1 [17]

and press enter. Enter Dilution Factor:1_

For the methods Total IgE, ECP and Tryptase, which only have one test the
change of the replicate and dilution factor is only possible in menu 1.4.1.2.Change
Test.

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Phadia 100 - User Manual Assay Run Editing Functions

Change Sample ID

The following steps describe how you can change the identity of a specific
sample.

1. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17 4

press yes. 1.Prepare Run?

3
2. In Enter Request press 4. 1.Prepare Run
1.Enter Request?

3. In Edit Request press yes. 1.Prepare Run

4.Edit Request?

4
4. In Edit Sample ID press 1.4.Edit Request
yes. 1.Edit Sample ID?

5
Warnings that may prevent entering

REMOTE MODE SELECTED

The instrument is set in PC remote mode.
NO SAMPLE ENTERED
There is no sample entered in the prepared run.
6
5. Select the sample ID by 1.4.1.Edit Sample ID
pressing no until the desired Select Sample ID:1239?
sample identity turns up. Then
press yes.

6. Press yes in Change 1.4.1.Edit Sample ID [1239]

Sample ID mode. 1.Change Sample ID?

7. Delete the old sample 1.4.1.1.Change Sample ID [1239]

identity and type the new (up Enter Sample ID:1239_
to 16 characters can be used)
one. Then press enter.

You can use the barcode reader to enter a new sample identity.

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Assay Run Editing Functions Phadia 100 - User Manual

Messages that can occur

SAMPLE ID ALREADY ENTERED

The entered sample ID has already been used in this run.
YOU CANNOT CHANGE TO CALIBRATORS
It is not possible to enter "cal" here if you want to add calibrators.
YOU CANNOT CHANGE TO CURVE CONTROL
It is not possible to enter "curve ctrl" here to add curve controls.

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Phadia 100 - User Manual Assay Run Editing Functions

Delete Sample ID

The following steps describes how you can delete a sample and all included tests.

1. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17

press yes. 1.Prepare Run? 4

2. In Enter Request press 4. 1.Prepare Run

3
1.Enter Request?

3. In Edit Request press yes. 1.Prepare Run

4.Edit Request?

4. In Edit Sample ID press 2. 1.4.Edit Request

4
1.Edit Sample ID?

5. In Delete Sample ID press 1.4.Edit Request

yes. 2.Delete Sample ID?

Warnings that may prevent entering 5

NO SAMPLE ENTERED

6
There is no sample entered in the prepared run.

6. Select the sample ID by 1.4.2.Delete Sample ID

pressing no until the desired Select Sample ID:1239?
sample identity appears. Then
press yes.

7. To delete the selected 1.4.2.Delete Sample ID

sample press enter. If you do PRESS ENTER TO DELETE SAMPLE ID
not want to delete the sample,
press mode.

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Assay Run Editing Functions Phadia 100 - User Manual

Delete Calibrators

The following steps describes how you can delete calibrators from a run.

1. In Prepare Run mode press Phadia 100 Ver.3.0 14:10:17

yes. 1.Prepare Run?

2. In Enter Request press 4. 1.Prepare Run

1.Enter Request?

3. In Edit Request press yes. 1.Prepare Run

4.Edit Request?

4. In Edit Sample ID press 3. 1.4.Edit Request

1.Edit Sample ID?

Warnings that may prevent entering

NO CALIBRATORS TO DELETE
There are no calibrator added to the prepared run.

5. In Delete Calibrators press 1.4.Edit Request

yes. 3.Delete Calibrators?

6. To select the method, DELETE CALIBRATORS FROM RUN

press the key below the method sIgE
name on the keyboard.
If you do not want to delete the
calibrators, press mode.

7. Press enter to delete the DELETE CALIBRATORS FROM RUN

calibrators. PRESS ENTER TO DELETE CALIBRATORS

Messages that can occur

CANNOT CHANGE TO CURVE CONTROL

It is not possible to remove calibrators and add curve controls.

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Phadia 100 - User Manual Assay Run Editing Functions

Select New Method

The following steps describes how you change the method when you are in Enter
Request in the Prepare Run mode.
You can enter tests belonging to different methods.
4
1. Type the sample identity 1.1.Enter Request [24]
and press enter. Enter Sample ID:

2. Press alt in the mode

where you enter tests.
1236 (sIgE)Test:_ [24] 3
3. Select the method

4
SELECT METHOD FOR CALIBRATORS
you want by pressing the sIgE tIgE ECP Tryp sIgG sIgA El-G El-A
key below the method
name. If there are more
Q W E R T Y U I O P
than eight methods de-
fined in the software use
alt to display more meth-
ods.

4. Type the tests you want 1236 (sIgG)Test:_ [24]

5
for the selected method. For
methods with only one test the
test will automatically be se-
lected.

NOTE! Do not forget to press enter one more time to save the tests you entered
6
to the sample identity.

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Assay Run Editing Functions Phadia 100 - User Manual

Select Quality Control Manually

The following steps describes how you choose quality controls with status
Manual when you are in Enter Request in the Prepare Run mode.
NOTE! In each method a maximum of 26 quality controls can be defined. In EliA
method 13 quality controls are predefined and the operator can define the
remaining 13.
You enter the quality controls from 1.1.Enter Request and instead of patient
identity you type qc.

1. In Prepare Run mode press Phadia 100 Ver.3.0 13:48:33

yes. 1.Prepare Run?

2. In Enter Request mode 1.Prepare Run

press yes. 1.Enter Request?

3. Type qc at the Enter 1.1.Enter Request [48]

Sample ID and press enter. Enter Sample ID:qc

4. Select the method SELECT METHOD FOR QC

for the quality control you sIgE tIgE ECP Tryp sIgG sIgA El-G El-A
want by pressing the key
below the method's name. Q W E R T Y U I O P

There is a pointer below each quality control that directs you to the right key.
If more than eight methods are defined in the software press alt to display more
methods.

5. Select the quality control 1.1.Enter Request

by pressing no until the desired Select Manual QC:ANA Pos-dn?
quality control turns up. Then
press yes.

6. Now you can continue 1.1.Enter Request [35]

adding sample identities or se- Enter Sample ID:_
lecting more quality controls
by typing qc again.

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Phadia 100 - User Manual Assay Run Editing Functions

Change Test

In Change Test you can change test name, replicate and dilution factor for a
specific sample.

1. In Prepare Run mode press Phadia 100 Ver.3.0 14:10:17 4

yes. 1.Prepare Run?

3
2. In Enter Request press 4. 1.Prepare Run
1.Enter Request?

3. In Edit Request press yes. 1.Prepare Run

4.Edit Request?

4
4. In Edit Sample ID press 1.4.Edit Request
yes. 1.Edit Sample ID?

5
Warnings that may prevent entering

REMOTE MODE SELECTED

6. Press 2. 1.4.1.Edit Sample ID [1239]

1.Change Sample ID?

7. Press yes. 1.4.1.Edit Sample ID [1239]

2.Change Test?

8. Select the test name you 1.4.1.2.Change Test [1239]

want to change by pressing no Select Test: sIgE-t3?
until the test name appears.
Then press yes.

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Assay Run Editing Functions Phadia 100 - User Manual

9. Delete the old test name 1.4.1.2.Change Test [1239]

and type the new test name (up Enter new Test name: (sIgE) t3_
to five characters) over the old
and press enter.
If you want to change the
method, press alt before you
enter the new test.
You will be requested to type
number of replicate and dilu-
tion.

Messages that can occur

ENTERED TEST DOES NOT EXIST

The entered test name is not defined in the selected method.
TEST ALREADY ENTERED
The entered test name has already been entered for this sample identity.
YOU CANNOT CHANGE TO PANEL
It is not possible to change to a panel here. Use Enter Request to add panels.
TOO MANY METHODS AT THE SAME TIME
By changing this test, the maximal number of four methods was exceeded.
METHOD NOT COMPATIBLE
Changing to this method is not possible since there already is a method that is
not compatible with the selected one.
INSTRUMENT DILUTION TOO HIGH
The instrument dilution exceeds 100.
WRONG BAR-CODE IDENTITY
Bar-code reader could not recognize test type. Check that you have not read
the EAN code instead of the article bar-code.

10. Select the method by SELECT METHOD

pressing the key below the sIgE tIgE ECP Tryp sIgG sIgA El-G El-A
method.
If a method with more
Q W E R T Y U I O P
than one test is selected you
will return to point 8.
If a method with only one test is
selected the test is added to the
run and you will come to the
Enter Replicate Number dis-
play (point 11).

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Phadia 100 - User Manual Assay Run Editing Functions

11. Type the desired number 1.4.1.2.Change Test [1239]

(between 1 and 5) of replicates Enter Replicate Number:1_
for the selected test and press
enter.
If you do not want to change
the replicate just press enter.

12. Press yes if you want the 1.4.1.2.Change Test [1239]

instrument to perform the dilu-
tion otherwise no.
Test Dilution:INSTRUMENT DILUTION? 4

13. Press yes if the sample is

3
1.4.1.2.Change Test [1239]
diluted manually before placed Test Dilution:PREDILUTED?
in the instrument.

14. Type the new factor over 1.4.1.2.Change Test [1239]

the old. Press enter.

4
Enter Dilution factor:5_

If the sample is to be diluted in the instrument you can select factor 1, 2, 5, 10,
20, 50 or 100.
If the sample is prediluted you can select a factor between 1 and 1000.

Messages that can occur

5
NO ACTIVE CALIBRATORS, ADD TO RUN?
There is no stored calibration curve for the method.
NO TEST POS. LEFT. Skip Test?
There is no position left for the ImmunoCAP/EliA Well. If you press yes the test
6
will be removed.
NO SAMPLE POS. LEFT. Skip Test?
There is no position left for sample. If you press yes the test will be removed.
PREDILUTED?
Press yes if the test is prediluted ten times (this example).
INSTRUMENT DILUTION?
Press yes if the test is to be diluted ten times (this example). The dilution is
carried out by the instrument.
TEST ALREADY ENTERED
The test name has already been entered for the sample.
TOO MANY METHODS AT THE SAME TIME
The number of methods possible to enter was exceeded. Maximal number of
methods that can be entered in one run is four (4).

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Assay Run Editing Functions Phadia 100 - User Manual

METHOD NOT COMPATIBLE

Adding this method is not possible, there is already a method used that is not
compatible with the method you selected.
INSTRUMENT DILUTION TOO HIGH
The wanted instrument dilution exceeds 100.

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Phadia 100 - User Manual Assay Run Editing Functions

Add Test

The following steps describes how you can add tests to a specific sample.

1. In Prepare Run mode press Phadia 100 Ver.3.0 14:10:17

yes. 1.Prepare Run? 4

2. In Enter Request press 4.

3
1.Prepare Run
1.Enter Request?

3. In Edit Request press yes. 1.Prepare Run

4.Edit Request?

4. In Edit Sample ID mode 1.4.Edit Request

4
press yes. 1.Edit Sample ID?

Warnings that may prevent entering

REMOTE MODE SELECTED

The instrument is set in PC remote mode.
5
NO SAMPLE ENTERED

6
There is no sample entered in the prepared run.

5. Select the sample ID by 1.4.1.Edit Sample ID

pressing no until the desired Select Sample ID:1239?
sample identity turns up. Then
press yes.

6. Press 3. 1.4.1.Edit Sample ID [1239]

1.Change Sample ID?

7. Press yes. 1.4.1.Edit Sample ID [1239]

3.Add Test?

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Assay Run Editing Functions Phadia 100 - User Manual

8. Type the test names and 1239 (sIgE)Test:_ [09]

press enter for each test name. t3, f2
You can also use the barcode
reader to enter tests.
To change the method press
alt. To change replicates or di-
lution factor type the test name
and press shift and enter at the
same time.
To save the entered tests press
enter, otherwise press mode.

9. Select the method by SELECT METHOD

pressing the key below the sIgE tIgE ECP Tryp sIgG sIgA El-G El-A
method.
If a method with more
Q W E R T Y U I O P
than one test is selected
you will return to the pre-
vious display (point 8) where
you can add the test for the new
method.
If a method with only one test
is selected the test is added to
the run and you will return to
the previous display (point 8).

10. Type the desired number 1239 (sIgE)Test:g2_ [09]

of replicates for the selected Enter Replicate Number:1_
test and press enter.
If you do not want to change
the replicate number just press
enter.

11. Press yes if the sample is 1239 (sIgE)Test:_ [09]

diluted before placed in instru- Test Dilution:PREDILUTED?
ment, otherwise no.

12. Press yes if you want the 1239 (sIgE)Test:_ [09]

instrument to perform the dilu- Test Dilution:INSTRUMENT DILUTION?
tion.

13. Delete or type over the 1239 (sIgE)Test:_ [09]

old dilution factor and type the Enter Dilution factor:5_
new factor. Press enter.

If the sample is to be diluted in the instrument enter dilution factor 1, 2, 5, 10,

20, 50 or 100.
If the sample is prediluted enter a dilution factor between 1 and 1000.

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Phadia 100 - User Manual Assay Run Editing Functions

14. To save the entered tests

1239 (sIgE)Test:_ [08]
press enter again.
g2. t3. f2
If you do not want to save the
tests press mode.

Messages that can occur

4
NO ACTIVE CALIBRATORS, ADD TO RUN?
There is no stored calibration curve for the method.

3
NO TEST POS. LEFT. Skip Test?
There is no position left for the ImmunoCAP/EliA Well. If you press yes the test
will be removed.
NO TEST POS. LEFT. Skip Panel?
There are not enough ImmunoCAP/EliA Well positions left. If you press yes the

4
test panel will be removed.
NO SAMPLE POS. LEFT. Skip Test?
There is no position left for sample. If you press yes the test will be removed.
NO SAMPLE POS. LEFT. Skip Panel?

5
There is no position left for sample. If you press yes the test panel will be
removed.
PREDILUTE?
Press yes if the sample is prediluted ten times (this example).
INSTRUMENT DILUTION?
Press yes if the test is to be diluted ten times (this example). The dilution is
carried out by the instrument.
TEST ALREADY ENTERED
6
The test name has already been entered for the sample.
TOO MANY METHODS AT THE SAME TIME
The number of methods possible to enter was exceeded. Maximal number of
methods that can be entered in one run is four (4).
METHOD NOT COMPATIBLE
Adding this method is not possible, there is already a method used that is not
compatible with the method you selected.
INSTRUMENT DILUTION TOO HIGH
The wanted instrument dilution exceeds 100.
ENTERED TEST DOES NOT EXIST
The entered test name is not defined in the currently selected method.
WRONG BAR-CODE IDENTITY
Bar-code was read, but could not be recognized as a test type. Check that
you have not read the EAN code instead of the article bar-code.

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Assay Run Editing Functions Phadia 100 - User Manual

Delete Test

The following steps describes how you can delete tests from a specific sample.

1. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17

press yes. 1.Prepare Run?

2. Press 4. 1.Prepare Run

1.Enter Request?

3. Press yes. 1.Prepare Run

4.Edit Request?

4. Press yes. 1.4.Edit Request

1.Edit Sample ID?

Warnings that may prevent entering

REMOTE MODE SELECTED

The instrument is set in PC remote mode.
NO SAMPLE ENTERED
There is no sample entered in the prepared run.

5. Select the sample ID by 1.4.1.Edit Sample ID

pressing no until the desired Select Sample ID:1239?
sample identity appears. Then
press yes.

6. Press 4. 1.4.1.Edit Sample ID [1239]

1.Change Sample ID?

7. Press yes. 1.4.1.Edit Sample ID [1239]

4.Delete Test?

8. Select the test name by 1.4.1.4.Delete Test [1239]

pressing no until the test name Select Test: sIgE-t3?
appears. Then press yes.

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Phadia 100 - User Manual Assay Run Editing Functions

9. To delete the selected test 1.4.1.4.Delete Test [1239]

press enter. PRESS ENTER TO DELETE TEST
If you do not want to delete the
test, press mode.
If all tests are deleted the sample
ID will be deleted as well.

3
4
5
6

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Assay Run Editing Functions Phadia 100 - User Manual

Add QC

To reach this function, you first have to login with the laboratory password (the
password at delivery is “unicap”).
It is recommended to use the minimum and maximum range values given in the
Directions for Use for the Quality Control, or for EliA on the package certificate.

1. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17

press 5. 1.Prepare Run?

2. In Method Setup mode Phadia 100 Ver.3.0 14:10:17

press yes. 5.Method Setup?

3. Press 2. 5.Method Setup

1.Add Method?

4. In Edit Method mode 5.Method Setup

press yes. 2.Edit Method?

5. Select the method for 5.2.Edit Method

which you want to define a Method: ImmunoCAP Specific IgE 0-100?
Quality Control by pressing no
until the desired method is dis- 5.2.Edit Method
played. Then press yes. Please wait...

6. Press 9. 5.2.Edit Method [sIgE]

1.General parameters?

7. In Quality control mode 5.2.Edit Method [sIgE]

press yes. 9.Quality control?

8. In Add QC mode press yes. 5.2.9.Quality control [sIgE]

1.Add QC?

9. Choose if the Quality Con- 5.2.9.1.Add QC [sIgE]

trol is to be set as ACTIVE, Status: ACTIVE?
MANUAL or INACTIVE by
pressing no until the desired sta-
tus is displayed. Then press yes.

ACTIVE means that the Quality Control will be added to all assay runs for the
selected method, INACTIVE means that the Quality Control will not be added
and MANUAL means that the Quality Control will be added if you decide so,
when an assay run is prepared.

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Phadia 100 - User Manual Assay Run Editing Functions

10. Type the Identity of the 5.2.9.1.Add QC [sIgE]

Quality Control (up to eight Identity:
characters) and press enter to
confirm this step.

Messages that can occur

4
SAME QUALITY CTRL IDENTITY ALREADY EXISTS
The identity is already used by another QC.

11. Type the test name and

press enter to confirm this step.
5.2.9.1.Add QC
Test name:
[sIgE]
3
Messages that can occur
4
ENTERED TEST DOES NOT EXIST
The test name does not exist for the method. Please, check the spelling.
SAME QC IDENTITY ALREADY EXISTS
The identity is already used by another QC.
5
12. Press 1, 2, 3, 4 or 5 de-
pending on how many repli-
cates you want to run. (1 is
5.2.9.1.Add QC
Replicate:1
[sIgE]
6
default.) Press enter to con-
firm this step.

Messages that can occur

Replicate: TOO HIGH!

The number of replicates is too high. Please, choose a number between 1 and 5.
Replicate: TOO LOW!
The number of replicates is too low. Please, choose a number between 1 and 5.

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Assay Run Editing Functions Phadia 100 - User Manual

13. Type the maximum al-

5.2.9.1.Add QC [sIgE]
lowed % CV (10.0 is default). %CV limit resp: 10.0
Press enter to confirm this step.

NOTE! Make sure not to enter values for ex-

pected mean value, long term expected stan-
dard deviation and maximum allowed stan-
dard deviation (point 14-16) if you want to use
the minimum and maximum range values from
the Directions for Use, otherwise the Range
minimum and maximum (point 17-18) will be
disabled.

14. Type the expected mean 5.2.9.1.Add QC [sIgE]

value (0.000 is default). Type 0 Expected value: 0.000
(zero) to deactivate the func-
tion. Press enter to confirm
this step.

NOTE! If you are using range minimum and maximum from the Directions for
Use, or for EliA from the package certificate, deactivate this function.

15. Type the long term ex- 5.2.9.1.Add QC [sIgE]

pected standard deviation for Expected s: 0.000
the Quality Control (0.000 is
default). Type 0 (zero) to deac-
tivate the function. Press enter
to confirm this step.

NOTE! If you are using range minimum and maximum from the Directions for
Use, or for EliA from the package certificate, deactivate this function.

16. Type the maximum al- 5.2.9.1.Add QC [sIgE]

lowed standard deviation for Limit s: 0.000
the Quality Control (1 is de-
fault, 3 is recommended by
Phadia AB). Type 0 (zero) to
deactivate the function. Press
enter to confirm this step.

NOTE! If you are using range minimum and maximum from the Directions for
Use, or for EliA from the package certificate, deactivate this function.

17. Type the lowest allowed 5.2.9.1.Add QC [sIgE]

concentration. Type 0 (zero) to Range minimum: 0.000
deactivate the function. Press
enter to confirm this step.

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Phadia 100 - User Manual Assay Run Editing Functions

If you are using ImmunoCAP Specific IgE Negative control as quotient, type 0
for Range minimum.
NOTE! If expected mean value, expected standard deviation and maximal
allowed standard deviation have been defined, the Range minimum will be
overridden.

18. Type the highest allowed 5.2.9.1.Add QC [sIgE]

concentration. Type 0 (zero) to Range maximum: 0.000
deactivate the function. Press
enter to confirm this step. 4
If you are using ImmunoCAP Specific IgE Negative control as quotient, type 100

3
for Range maximum.
NOTE! If expected mean value, expected standard deviation and maximal
allowed standard deviation have been defined, the Range maximum will be
overridden.

19. Type the lot number (used

4
5.2.9.1.Add QC [sIgE]
mainly for Phadia controls). Lot number: 0.000
Press enter to confirm this step.

20. If the Quality Control is 5.2.9.1.Add QC [sIgE]

prediluted type a dilution fac-

5
Dilution factor: 1
tor between 1-100 (1 is de-
fault). Press enter to confirm
this step.

21. Choose the type of QC

6
5.2.9.1.Add QC [sIgE]
you want, CONCENTRA- Type of QC: CONCENTRATION?
TION, QUOTIENT or
QUALITATIVE, by pressing
no until the desired type is dis-
played. Then press yes.

22. Type the instrument dilu- 5.2.9.1.Add QC [sIgE]

tion factor. Choose between 1, Instr. dilution factor: 1
2, 5, 10, 20, 50 or 100. Press
enter to confirm this step.

23. Type a number between

5.2.9.1.Add QC [sIgE]
1-99. A low number means that Order: 1
the Quality Control will be pro-
cessed before Quality Controls
with higher numbers. Type 0
(zero) to use the default order
of the Quality Control. Press
enter to confirm this step.

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Assay Run Editing Functions Phadia 100 - User Manual

NOTE! Only use this function if you want to change the default order of the
Quality Controls.

24. The instrument displays a 5.2.9.1.Add QC [sIgE]

message that the quality con- QUALITY CONTROL ADDED
trol is added. You will then
return to th Add QC mode. 5.2.9.Quality control [sIgE]
1.Add QC?

Run at least 20 assay runs to get the mean for the expected value and expected
standard deviation in the Quality Control log. Then you can use these obtained
values to change expected concentration and standard deviation in Edit QC.

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Phadia 100 - User Manual Assay Run Editing Functions

Edit QC

In the Edit QC mode it is possible to change status, identity, test name, replicate,
response, expected concetration, standard deviation, limit standard deviation,
range minimum and maximum, log start date and lot number.
To reach this function, you first have to login with the laboratory password (the 4
password at delivery is “unicap”).

3
1. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17
press 5. 1.Prepare Run?

2. In Method Setup mode Phadia 100 Ver.3.0 14:10:17

press yes. 5.Method Setup?

3. Press 2. 5.Method Setup

1.Add Method?
4
4. In Edit Method mode 5.Method Setup

5
press yes. 2.Edit Method?

5. Select the method for 5.2.Edit Method

which you want to define a Method: ImmunoCAP Specific IgE 0-100?
Quality Control by pressing no

6
until the desired method is dis- 5.2.Edit Method
played. Then press yes. Please wait...

6. Press 9. 5.2.Edit Method [sIgE]

1.General parameters?

7. In Quality control mode 5.2.Edit Method [sIgE]

press yes. 9.Quality control?

8. Press 2. 5.2.9.Quality control [sIgE]

1.Add QC?

9. In Edit QC mode press yes. 5.2.9.Quality control [sIgE]

2.Edit QC?

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Assay Run Editing Functions Phadia 100 - User Manual

Warnings that may prevent entering

NO QUALITY CONTROLS EXIST

There is no QC defined for the method.

10. Select the Quality Control 5.2.9.2.Edit QC [sIgE]

you want to edit by pressing no Quality control: sIgE Pos d1?
until the desired Quality Con-
trol is displayed. Then press yes.

Set status
You can set the status to ACTIVE, INACTIVE or MANUAL. ACTIVE means
that the Quality Control will be added to all assay runs for the selected method,
INACTIVE means that the Quality Control will not be added and MANUAL
means that the Quality Control will be added if you decide so, when an assay
run is prepared.

1. Press yes. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

1.Status?

2. Choose if the Quality 5.2.9.2.Edit QC [sIgE/sIgE Pos]

Control is to be set as ACTIVE, Status: ACTIVE?
MANUAL or INACTIVE by
pressing no until the desired
status is displayed. Then press
yes. The status will be set.

Identity
The following step describes how you can change the identity of the Quality
Control.

1. In Edit QC mode press 2. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

1.Status?

2. Press yes. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

2.Identity?

3. Delete or type over the 5.2.9.2.Edit QC [sIgE/sIgE Pos]

old Quality Control identity Identity: sIgE Pos
and type the new identity (up
to eight characters). Press en-
ter to confirm this step.

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Phadia 100 - User Manual Assay Run Editing Functions

Messages that can occur

SAME QUALITY CTRL IDENTITY ALREADY EXISTS

The identity is already used by another QC.

Test name 4
The following step describes how you can change the test name for the Quality
Control.

1. In Edit QC mode press 3. 5.2.9.2.Edit QC

1.Status?
[sIgE/sIgE Pos] 3
2. Press yes. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

4
3.Test name?

3. Delete or type over the 5.2.9.2.Edit QC [sIgE/sIgE Pos]

old test name for the Quality Test name: d1
Control. Type the new test
name and press enter to con-

5
firm this step.

Messages that can occur

ENTERED TEST DOES NOT EXIST

The test name does not exist for the method. Please, check the spelling.
6
SAME QC IDENTITY ALREADY EXISTS
The identity is already used by another QC.

Replicate
The following step describes how you can change the number of replicates you
want to run. You can set the number of replicates to 1, 2, 3, 4 or 5.

1. In Edit QC mode press 4. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

1.Status?

2. Press yes. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

4.Replicate?

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Assay Run Editing Functions Phadia 100 - User Manual

3. Delete or type over the 5.2.9.2.Edit QC [sIgE/sIgE Pos]

old number of replicates. Press Replicate: 1
1, 2, 3, 4 or 5 depending on
how many replicates you want
to run. Press enter to confirm
this step.

Messages that can occur

Replicate: TOO HIGH!

The number of replicates is too high. Please, choose a number between 1 and 5.
Replicate: TOO LOW!
The number of replicates is too low. Please, choose a number between 1 and 5.

Coefficient of variance limit response

The following step describes how you can change the maximum allowed % CV.

1. In Edit QC mode press 5. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

1.Status?

2. Press yes. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

5.%CV limit resp?

3. Delete or type over the 5.2.9.2.Edit QC [sIgE/sIgE Pos]

old maximum allowed % CV. %CV limit resp: 0.1
Type the new maximum al-
lowed % CV and press enter
to confirm this step.

Expected concentration
The following step describes how you can change the expected mean value. It
is also possible to deactivate this function.
After adding a Quality Control it is recommended to run at least 20 assay runs
to get the expected mean value in the Quality Control log.
You find the expected mean value at the end of the Quality Control log.

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Phadia 100 - User Manual Assay Run Editing Functions

LOG DATA

RUN DATE,TIME---LOT NO---CAL CODE--CONCENTRATION

090512 11:14 AVMAB 1F 0.72 0.65
090513 11:18 AVMAB 1T 0.66 0.68
090514 12:58 AVMAB 1T 0.61 0.69
090515 13:02 AVMAB 2T 0.70 0.69
090516 11:05 AVMAB 2T 0.73 0.69
090517 12:33 AVMAC 2T 0.72 0.75
090518 12:53* AVMAC 2T <0.35 0.78 4
090519 12:43 AVMAC 2T 0.77 0.74

3
Calculated mean concentration for LOT NO------MEAN-------s-----%CV---
all QC points with the same lot no
AVMAB 0.68 0.03 5.1
AVMAC 0.75 0.02 2.8

0354, 090420 10:12, 2.3, 032

4
1. In Edit QC mode press 6.

5
5.2.9.2.Edit QC [sIgE/sIgE Pos]
1.Status?

2. Press yes. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

6.Expected conc?

3. Delete or type over the

6
5.2.9.2.Edit QC [sIgE/sIgE Pos]
old expected mean value. Type Expected value: 3.5
the new expected mean value
or type 0 (zero) to deactivate
the function. Press enter to con-
firm this step.

NOTE! If you are using range minimum and maximum from the Directions for
Use, or for EliA from the package certificate, deactivate this function.

Expected standard deviation

The following step describes how you can change the long term expected
standard deviation. It is also possible to deactivate this function.
After adding a Quality Control it is recommended to run at least 20 assay runs
to get the expected standard deviation in the Quality Control log.
You find the expected mean value at the end of the Quality Control log.

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Assay Run Editing Functions Phadia 100 - User Manual

LOG DATA

RUN DATE,TIME---LOT NO---CAL CODE--CONCENTRATION

LOT NO------MEAN-------s-----%CV---
AVMAB 0.68 0.03 5.1
AVMAC 0.75 0.02 2.8
Calculated standard deviation for
all QC points with the same lot no
0354, 090420 10:12, 2.3, 032

1. In Edit QC mode press 7. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

1.Status?

2. Press yes. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

7.Expected s?

3. Delete or type over the 5.2.9.2.Edit QC [sIgE/sIgE Pos]

old long term expected stan- Expected s: 0.2
dard deviation. Type the new
long term expected standard
deviation or type 0 (zero) to
deactivate the function. Press
enter to confirm this step.

NOTE! If you are using range minimum and maximum from the Directions for
Use, or for EliA from the package certificate, deactivate this function.

Limit s
The following step describes how you can change the maximum allowed
standard deviation. It is also possible to deactivate this function.

1. In Edit QC mode press 8. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

1.Status?

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Phadia 100 - User Manual Assay Run Editing Functions

2. Press yes. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

8.Limit s?

3. Delete or type over the 5.2.9.2.Edit QC [sIgE/sIgE Pos]

old maximum allowed stan- Limit s: 3
dard deviation. Type the new
maximum allowed standard de-
viation (3 is recommended by
Phadia AB) or type 0 (zero) to
deactivate the function. Press
enter to confirm this step. 4
NOTE! If you are using range minimum and maximum from the Directions for

3
Use, or for EliA from the package certificate, deactivate this function.

Range minimum
The following step describes how you can change the lowest allowed concen-
tration. It is also possible to deactivate this function.

1. In Edit QC mode press 9. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

4
1.Status?

5
2. Press yes. 5.2.9.2.Edit QC [sIgE/sIgE Pos]
9.Range minimum?

3. Delete or type over the 5.2.9.2.Edit QC [sIgE/sIgE Pos]

old lowest allowed concentra- Range minimum: 2.8
tion. Type the new lowest al-

6
lowed concentration or type 0
(zero) to deactivate the func-
tion. Press enter to confirm
this step.

Range maximum
The following step describes how you can change the highest allowed concen-
tration. It is also possible to deactivate this function.

1. In Edit QC mode press 10. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

1.Status?

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Assay Run Editing Functions Phadia 100 - User Manual

2. Press yes. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

10.Range maximum?

3. Delete or type over the 5.2.9.2.Edit QC [sIgE/sIgE Pos]

old highest allowed concentra- Range maximum: 4.2
tion. Type the new highest al-
lowed concentration or type 0
(zero) to deactivate the func-
tion. Press enter to confirm
this step.

If you are using ImmunoCAP Specific IgE Negative control as quotient, type 100
for Range maximum.
NOTE! If expected mean value, expected standard deviation and maximal
allowed standard deviation have been defined, the Range maximum will be
overridden.

Log start date

The following step describes how you can change the log start date.

1. In Edit QC mode press 11. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

1.Status?

2. Press yes. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

11.Log start date?

3. Delete or type over the 5.2.9.2.Edit QC [sIgE/sIgE Pos]

old log start date. Type the new Log start date: 060410
log start date and press enter
to confirm this step.

Lot number
The following step describes how you can change the lot number (used mainly
for Phadia controls).

1. In Edit QC mode press 12. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

1.Status?

2. Press yes. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

12.Lot number?

3. Delete or type over the 5.2.9.2.Edit QC [sIgE/sIgE Pos]

old lot number. Type the new Lot number: 14371956
lot number and press enter to
confirm this step.

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Phadia 100 - User Manual Assay Run Editing Functions

Predilution factor
The following step describes how you can change the predilution factor.

1. In Edit QC mode press 13. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

1.Status?

2. Press yes. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

13.Predilution factor?
4
3. Delete or type over the 5.2.9.2.Edit QC [sIgE/sIgE Pos]
old predilution factor. If the Dilution factor: 10
Quality Control is prediluted

3
type a dilution factor between
1-100. If the Quality Control is
not prediluted, type 1. Press
enter to confirm this step.

Instrument dilution factor

The following step describes how you can change the instrument dilution factor.
4
5
1. In Edit QC mode press 14. 5.2.9.2.Edit QC [sIgE/sIgE Pos]
1.Status?

2. Press yes. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

14.Instr. dilution factor?

6
3. Delete or type over the 5.2.9.2.Edit QC [sIgE/sIgE Pos]
old instrument dilution factor. Instr. dilution factor: 10
Type the new instrument dilu-
tion factor. Choose between 1,
2, 5, 10, 20, 50 or 100. Press
enter to confirm this step.

Type of Quality Control

You can set the type of the Quality control to CONCENTRATION, QUO-
TIENT or QUALITATIVE.

1. In Edit QC mode press 15. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

1.Status?

2. Press yes. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

15.Type of QC?

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Assay Run Editing Functions Phadia 100 - User Manual

3. Choose the type of QC 5.2.9.2.Edit QC [sIgE/sIgE Pos]

you want, CONCENTRA- Type of QC: CONCENTRATION?
TION, QUOTIENT or
QUALITATIVE, by pressing
no until the desired type is dis-
played. Then press yes.

Order
The following step describes how you can change when in the assay run the
Quality Control will be processed.

1. In Edit QC mode press 16. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

1.Status?

2. Press yes. 5.2.9.2.Edit QC [sIgE/sIgE Pos]

16.Order?

3. Delete or type over the 5.2.9.2.Edit QC [sIgE/sIgE Pos]

old order number. Type a num- Order: 0
ber between 1-99. A low num-
ber means that the Quality
Control will be processed be-
fore Quality Controls with
higher numbers. Type 0 (zero)
to use the default order of the
Quality Control. Press enter
to confirm this step.

NOTE! Only use this function if you want to change the default order of the
Quality Controls.

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Phadia 100 - User Manual Assay Run Editing Functions

Change QC with new Lot

When changing to a new lot number, it is necessary to change the expected

concentration, the expected s and the limit s, or the range minimum and
maximum, besides the lot number. You might also want to change the log start
date. These values can be changed in two ways, either as described in Edit QC
or by pressing shift and enter at the same time when loading Quality Control 4
vials to the instrument.

3
4
5
6

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Assay Run Editing Functions Phadia 100 - User Manual

Skip ImmunoCAP/EliA Well Loading

The following steps describes how to skip loading a specific ImmunoCAP/EliA

Well when you are in Load and Start mode. This can be done if for example you
find that you do not have the required ImmunoCAP in stock.

1. You can skip loading the 1.3.3.Load ImmunoCAP/EliA Well

specific ImmunoCAP/EliA Well LOAD 3 sIgE d1
by pressing del.

2. Press yes if you want to 1.3.3.Load ImmunoCAP/EliA Well

skip further loading of d1. SKIP ALL REMAINING sIgE d1?
Then you can continue loading
as usual.

3. At the end of the loading 1.3.3.Load ImmunoCAP/EliA Well

of ImmunoCAP/EliA Well you LOAD 3 DUMMY ImmunoCAP
have to fill the skipped posi-
tions with Dummy Immuno- 1.3.Load and Start
CAP/EliA Well. 4.Start Process?

It is necessary to fill something in each position for the Wash Rake, otherwise
most of the washing efficiency will be lost in the empty positions.
In the next assay run you will automatically be asked if you want to run tests
requiring ImmunoCAP/EliA Well skipped. You might be asked the question
several times during preparation of the run, but you do not have to run the
sample. You will not be asked the same question in the following runs.

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Phadia 100 - User Manual Assay Run Editing Functions

Load Old Run

In some cases you may want to load a stored run. This function will make a copy
of requests for one already assayed and stored run, for example if you want to
rerun a whole assay run. Choose the assay run you want to copy and the requests
will be stored. Once the assay run is stored you may edit it. The instrument stores
the last 20 assay runs. The assay runs are identified by a sequence number and 4
the time and date when the run was processed.

3
1. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17
press yes. 1.Prepare Run?

2. Press 5. 1.Prepare Run

1.Enter Request?

3. Press yes. 1.Prepare Run

5.Load Old run? 4
5
Warnings that may prevent entering

REMOTE MODE SELECTED

The instrument is set in PC remote mode.
RUN IS PREPARED
Another run is already prepared to be processed. Abort or process the run before
loading old run.
NO RUNS EXIST
6
There is no old run to load.

4. Select the old run by press- 1.5.Load Old Run

ing no until the desired assay Run (34) 090613 08:57
run appears. Then press yes.

5. Press enter to load the 1.5.Load Old Run

run you selected. PRESS ENTER TO LOAD OLD RUN

You will return to the Prepare Run mode from where you can continue working
with the selected run.

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Assay Run Editing Functions Phadia 100 - User Manual

Messages that can occur

METHOD NOT COMPATIBLE

Currently defined methods does not match the methods in the selected run.

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Phadia 100 - User Manual Assay Run Editing Functions

Abort Prepared Run

If you want to abort a prepared run or a run that is being processed select the
Abort Run mode. When you aborted the process you have to remove the
reagents, samples and ImmunoCAP/EliA Well from the instrument.
4
1. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17
press 2. 1.Prepare Run?

2. Press yes. Phadia 100 Ver.3.0

2.Abort Run?
14:10:17
3
3. Press yes if you want to 2.Abort Run
abort a run that is prepared, 1.Abort Prepared Run?

4
i.e., not started.

Then you can choose between deleting all request data, remove single
ImmunoCAP/EliA Well or remove all Immuno-CAP/EliA Well.

5
6

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Assay Run Editing Functions Phadia 100 - User Manual

Delete All Request Data

1. In Abort Prepared Run 2.1.Abort Prepared Run

mode press yes to delete all the 1.Delete all Request Data?
request data for the prepared
run.

Warnings that may prevent entering

RUN IS NOT PREPARED

There is no run currently prepared.
ImmunoCAP/EliA Well IS LOADED
ImmunoCAP/EliA Well has already been loaded. Use the menu Remove All
ImmunoCAP and Remove Single ImmunoCAP to remove them.

2. Press enter to delete the 2.1.1.Delete all Request Data

recently prepared run. PRESS ENTER TO DELETE

There will be a message telling you if the request data is deleted or not.

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Phadia 100 - User Manual Assay Run Editing Functions

Remove Single ImmunoCAP/EliA Well

This is used in case the wrong ImmunoCAP/EliA Well was loaded, and this was
noticed before starting the process.

1. In the Abort Prepared Run 2.1.Abort Prepared Run 4

mode press no. 1.Delete all Request Data?

3
2. Press yes. 2.1.Abort Prepared Run
2.Remove Single ImmunoCAP/Elia Well?

Warnings that may prevent entering

PROCESS IS RUNNING
You cannot remove any ImmunoCAP/EliA Well when an assay run is being
processed.
4
3. Press no to move the
ImmunoCAP carousel to the
2.1.2.Remove Single ImmunoCAP/EliA Well
23: sIgE t17 PRESS ENTER IF REMOVED
5
next position. Press no and
shift at the same time to move

6
the carousel to previous posi-
tion.
You have to remove the ImmunoCAP/EliA Well from the displayed position
manually. Press lid open to open the processing lid.
Find the correct ImmunoCAP/EliA Well and remove it manually.
Close the lid. Now you can press enter.
There will be a message telling you that the ImmunoCAP/EliA Well is removed.
ImmunoCAP/EliA Well will get the status not loaded in the prepared run.
To exit press mode.
NOTE! If there is no ImmunoCAP/EliA Well with status loaded in the prepared
run there will only be a position displayed and enter has no function.

Messages that can occur

POSITIONING...
The ImmunoCAP Carousel is moving to a new position.

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Assay Run Editing Functions Phadia 100 - User Manual

NOTE! ImmunoCAP and EliA Wells are not la-

belled. Due to this fact you have to discard
them.

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Phadia 100 - User Manual Assay Run Editing Functions

Remove All ImmunoCAP/EliA Well

1. In the Abort Prepared Run 2.1.Abort Prepared Run

mode press 3. 1.Delete all Request Data?

2. Press yes. 4
2.1.Abort Prepared Run
3.Remove all ImmunoCAP/EliA Well?

Warnings that may prevent entering

3
PROCESS IS RUNNING
You cannot remove any ImmunoCAP/EliA Well when an assay run is being
processed.

4
3. Press enter to remove all 2.1.3.Remove all ImmunoCAP/EliA Well
the ImmunoCAP/EliA Well.

5
PRESS ENTER TO REMOVE
The instrument will remove all
ImmunoCAP/EliA Well from
the carousel to the waste con-
tainer.
A message occurs which tells
2.1.3.Remove all ImmunoCAP/EliA Well
you that ImmunoCAP/EliA

6
ALL IMMUNOCAP/EliA WELL REMOVED
Well has been removed.

NOTE! Make sure that the ImmunoCAP Waste Container is empty before
pressing enter if the ImmunoCAP/EliA Well that you are removing are new and
you want to use them. Otherwise used and new ImmunoCAP/EliA Well will be
mixed in the ImmunoCAP Waste Container. Please, empty the ImmunoCAP
Waste Container.

NOTE! ImmunoCAP and EliA Wells are not la-

belled. Due to this fact you have to discard
them.

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Assay Run Editing Functions Phadia 100 - User Manual

Abort Process

If you want to abort a run that is being processed, you can select the Abort Run
mode. When you have aborted the process, you have to remove the reagents and
ImmunoCAP/EliA Well from the instrument.

1. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17

press 2. 1.Prepare Run?

2. Press yes. Phadia 100 Ver.3.0 14:10:17

2.Abort Run?

3. Press no if you do not 2.Abort Run

want to abort a prepared run. 1.Abort Prepared Run?

4. Press yes to abort the run 2.Abort Run

that is being processed, other- 2.Abort Process?
wise press no.

Warnings that may prevent entering

PROCESS IS NOT RUNNING

There is no process running at the moment.

5. Press enter to abort pro- 2.2.Abort Run

cess. You will be prompted to PRESS ENTER TO ABORT PROCESS
empty and clean the instrument.

2.2.Abort Run
EMPTY AND RINSE INSTRUMENT

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Phadia 100 - User Manual Assay Run Data Evaluation

Chapter 5 - Assay Run Data Evaluation

This chapter describes the data evaluation
with Phadia 100

Data Evaluation
Print Patient Report
2
3
2
Print All Samples in a Run 3
5

3
Print Specific Sample 4

Print Laboratory Report 5

Print Specific Run 5
Re-evaluate and Print specific Run with selected Calibrators 6
Switch Curve Controls 7

4
Disable Curve Control 8
Disable Blank Error 9
Disable Fatal Error 9

Print Lists 11
Run Summary 12
Export Data
Import Data
13
15 5
6

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Assay Run Data Evaluation Phadia 100 - User Manual

Data Evaluation

In the Data Evaluation mode you can print patient reports, laboratory reports
and export/import data for storage or evaluation. The last 20 assay runs are
automatically stored. The laboratory report and patient reports for these runs
can be printed at any time.
Depending on your instrument, it is possible to save assay runs to a USB
memory, an external USB hard drive or a diskette. Saved assay runs can be
imported later on when you want to make a printout. Save your last 20 assay
runs to a USB memory, an external USB hard drive or a diskette before
importing old runs, as the old runs will overwrite the current runs. The diskette
will be instrument specific and cannot be used in another instrument.
For printouts, see chapter 10.

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Phadia 100 - User Manual Assay Run Data Evaluation

Print Patient Report

Patient reports can be printed for a whole assay run or a specific sample in a run.

1. In Prepare Run mode

press 3.
Phadia 100 Ver.3.0
1.Prepare Run?
14:10:17
2
2. Press yes. Phadia 100 Ver.3.0 14:10:17
5

3
3.Data Evaluation?

3. Press yes. 3.Data Evaluation

1.Print Patient Report?

Print All Samples in a Run

4
1. Press yes. 3.Data Evaluation

5
1.Print Patient Report?

2. Press yes. 3.1.Print Patient Report

1.All Samples in a Run?

6
Warnings that may prevent entering

NO RUNS EXIST
There is no processed run to print patient reports for.

3. Select the assay run you 3.1.1.All Samples in a Run

want to print by pressing yes Run: (34) 090503 08:57?
until the run appears, then press
no.

The assay run is identified with a sequence number and the date and time when
it was processed. The patient report will be printed.

Messages that can occur

NO SAMPLE IN RUN
The selected run does not contain any unknown sample to print patient reports
from.

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Assay Run Data Evaluation Phadia 100 - User Manual

Print Specific Sample

1. In Print Patient Report 3.Data Evaluation

press yes. 1.Print Patient Report?

2. Press no. 3.1.Print Patient Report

1.All Samples in a Run?

3. Press yes. 3.1.Print Patient Report

2.Specific Sample?

Warnings that may prevent entering

NO RUNS EXIST
There is no processed run to print patient reports for.

4. Select the assay run by 3.1.2.Specific Sample

pressing no until the run ap- Run: (34) 090503 08:57?
pears, then press yes.

5. Select the sample you 3.1.2.Specific Sample

want to print by pressing no Select Sample ID: 3452?
until the sample appears, then
press yes.
The Patient Report is printed.

Messages that can occur

INCLUDE TESTS FROM ANOTHER RUN?

The sample is divided into several assay runs, press yes to include another assay
run and no if you do not want to include another assay run.

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Phadia 100 - User Manual Assay Run Data Evaluation

Print Laboratory Report

In this module you can print a summary of processed runs stored in the
instrument, laboratory reports for processed runs and a laboratory report for
processed runs with selected calibrators.

1. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17

2
press 3. 1.Prepare Run?
5
2. Press yes. Phadia 100 Ver.3.0
3.Data Evaluation?
14:10:17
3
3. In Print Patient Report 3.Data Evaluation
press no. 1.Print Patient Report?

4. Press yes. 3.Data Evaluation

2.Print Laboratory Report?
4
5
Print Specific Run
In this menu you can print a specific run. Follow the description below.

1. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17

6
press 3. 1.Prepare Run?

2. Press yes. Phadia 100 Ver.3.0 14:10:17

3.Data Evaluation?

3. Press 2. 3.Data Evaluation

1.Print Patient Report?

4. Press yes. 3.Data Evaluation

2.Print Laboratory Report?

5. Press no. 3.2.Print Laboratory Report

1.Summary of Runs?

6. Press yes. 3.2.Print Laboratory Report

2.Specific Run?

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Assay Run Data Evaluation Phadia 100 - User Manual

Warnings that may prevent entering

NO RUNS EXIST
There is no processed run to print laboratory reports for.

7. Select the assay run you 3.2.2.Specific Run

want to print by pressing no Run: (34) 090503 08:57
until the run appears, then press
yes.
The laboratory report will be
printed.

Re-evaluate and Print specific Run with

selected Calibrators
The following steps describes how you can re-evaluate a run against other
calibrators. The calibrator code has to be the same as in the assay run and the
status of the calibrators has to be accepted.
This will not affect the active stored curve.

1. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17

press 3. 1.Prepare Run?

2. Press yes. Phadia 100 Ver.3.0 14:10:17

3.Data Evaluation?

3. Press 2. 3.Data Evaluation

1.Print Patient Report?

4. Press yes. 3.Data Evaluation

2.Print Laboratory Report?

5. Press 3. 3.2.Print Laboratory Report

1.Summary of Runs?

Warnings that may prevent entering

NO RUNS EXIST
There is no processed run to print laboratory reports for.

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Phadia 100 - User Manual Assay Run Data Evaluation

6. Press yes.
3.2.Print Laboratory Report
3.Specific Run, select Calibrators?
7. Select the assay run you 3.2.3.Specific Run, select Calibrators
want to print by pressing no Run: (34) 090503 08:57?
until the run appears, then press
yes.

8. Press no until the calibra-

tors you want appears, then
press yes.
3.2.3.Specific Run, select Calibrators
sIgE calibrators: 091005 11:13, 15?
2
Press enter for printing.
5
The calibrators are identified by the method, date, time when processed and the
calibration code. They will be used to evaluate the selected assay run and the
laboratory report is printed. 3
Messages that can occur

NOT SAME CAL CODE AS RUN, CANNOT USE

4
The selected calibrators do not have the same calibration code as the run and

5
cannot be used for evaluation.

Switch Curve Controls

If you by mistake have placed the CC-vials in wrong position, you can switch
back and still get out the results. 6
1. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17
press 3. 1.Prepare Run?

2. Press yes. Phadia 100 Ver.3.0 14:10:17

3.Data Evaluation?

3. Press 2. 3.Data Evaluation

1.Print Patient Report?

4. Press yes. 3.Data Evaluation

2.Print Laboratory Report?

5. To switch data press 4 3.2.Print Laboratory Report

in Print Laboratory mode. 1.Summary of Runs?

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Assay Run Data Evaluation Phadia 100 - User Manual

6. Press yes. 3.2.Print Laboratory Report

4.Specific Run, switch CC?

7. Press yes.
3.2.4.Specific Run,switch CC
Run: (34) 090503 08:57?
8. Press yes for each method
3.2.4.Specific Run, switch CC
you want to switch.
SWITCH CURVE CONTROLS FOR sIgE?
The laboratory report is
printed.

Disable Curve Controls

There is a possibility to print results when Curve Controls are not OK. This
function is applicable for example when wrong Curve Controls have been used,
or when the Curve Controls vials by mistake have been used two times. Disable
Curve Controls can be used both for methods using two curve controls in single
replicates, and methods using one curve control in duplicate.

NOTE! Restricted use is recommended. Make

sure that the results are not affected and
Quality Controls are within limits, before using
this function.

1. To disable Curve Controls 3.2.Print Laboratory Report

press 5 in Print Laboratory Re- 1.Summary of Runs?
port mode.

2. Press yes. 3.2.Print Laboratory Report

5.Specific Run, disable CC?

3. Select the assay run in 3.2.5.Specific Run, disable CC

which you want to disable Run: (34) 090503 08:57?
Curve Controls by pressing
no until the assay run
appears, then press yes.

4. Press yes for each method 3.2.5.Specific Run, disable CC

in which you want to disable DISABLE CURVE CONTROLS FOR sIgE?
Curve Controls.
The laboratory report is auto-
matically printed.

NOTE! It is always the decision of the responsible

laboratory manager to accept an assay run.
Other assay performance parameters have to
be taken into consideration.

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Phadia 100 - User Manual Assay Run Data Evaluation

Disable Blank Error

There is a possibility to print results when the Blank Check has detected a Blank
Error. This function should only be used under certain circumstances and only
for the following two Blank Errors:

REAGENT BLANK IS TOO HIGH

DARK BLANK IS TOO HIGH

Only disable REAGENT BLANK IS TOO HIGH when you can confirm that the
2
reagent blank is measured correctly by running a 6.9.5.Run Blanks, see chapter
11, Maintenance. 5
This function should be used with caution, as blank errors might lead to
unreliable results, see chapter 12, Error Handling.
3
1. To disable blank error 3.2.Print Laboratory Report
handling, press 6 in Print Labo-

4
1.Summary of Runs?
ratory Report mode.

2. Press yes. 3.2.Print Laboratory Report

6.Specific Run, disable blank error?

5
3. Select the assay run for 3.2.6.Specific Run, disable blank error
which you want to disable Run: (34) 090503 08:57?
blank error handling by press-
ing no until the assay run ap-
pears, then press yes.

NOTE! It is always the decision of the responsible

laboratory manager to accept an assay run.
Other assay performance parameters have to
6
be taken into consideration.

Disable Fatal Error

There is a possibility to print results when the instrument has detected one of
the following Processing Errors:

FATAL #52.00 TOO LITTLE WASH LOADED

FATAL #53.00 WASH/RINSE HAVE BEEN MIXED

This function should be used with caution, as these errors might lead to
unreliable results, see chapter 12, Error Handling.

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Assay Run Data Evaluation Phadia 100 - User Manual

1. To disable fatal error han- 3.2.Print Laboratory Report

dling, press 7 in Print Labora- 1.Summary of Runs?
tory Report mode.

2. Press yes. 3.2.Print Laboratory Report

7.Specific Run, disable fatal error?

3. Select the assay run in 3.2.7.Specific Run, disable fatal error

which you want to disable fatal Run: (34) 090503 08:57?
error handling by pressing no
until the assay run appears, then
press yes.

NOTE! It is always the decision of the responsible

laboratory manager to accept an assay run.
Other assay performance parameters have to
be taken into consideration.

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Phadia 100 - User Manual Assay Run Data Evaluation

Print Lists

1. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17

press yes.

2
1.Prepare Run?

2. Press 2. 1.Prepare Run

1.Enter Request?

3. Press yes. 5

3
1.Prepare Run
2.Print Lists?

4. To select the list to be SELECT PRINTOUT

printed, press the key below REQUEST CONSUMP DISTR
the list name on the key board.
You can choose between re-
quest, consumption and distri-
bution lists.
The list is printed and you will
return to the Prepare Run mode.
4
If there is an error message for the assay run, the distribution list will
automatically be printed in connection to the laboratory report.
For more information see chapter 10, Printouts. 5
6

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Assay Run Data Evaluation Phadia 100 - User Manual

Run Summary

This printout lists processed runs stored in the instrument, with date and time for
run, methods, calibration code and mode. To print the summary of runs select
the option 3.2.1.Summary of Runs on the instrument.

1. In Prepare Run mode press Phadia 100 Ver.3.0 14:10:17

3. 1.Prepare Run?

2. Press yes. Phadia 100 Ver.3.0 14:10:17

3.Data Evaluation?

3. Press 2. 3.Data Evaluation

1.Print Patient Report?

4. Press yes. 3.Data Evaluation

2.Print Laboratory Report?

5. Press yes. 3.2.Print Laboratory Report

The list will be printed. 1.Summary of Runs?

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Phadia 100 - User Manual Assay Run Data Evaluation

Export Data

Data can be exported to a USB memory, an external USB hard drive or a diskette
and then be evaluated.

1. In Prepare Run mode press

3.
Phadia 100 Ver.3.0
1.Prepare Run?
14:10:17 2
5

3
2. Press yes. Phadia 100 Ver.3.0 14:10:17
3.Data Evaluation?

3. Press yes if you want to 3.Data Evaluation

print the patient Report, other- 1.Print Patient Report?
wise press no.

4. Press yes if you want to

print the Laboratory Report,
3.Data Evaluation
2.Print Laboratory Report?
4
otherwise press no.

5. Press yes if you want to

export data, otherwise press no.
3.Data Evaluation
3.Export Data? 5
Warnings that may prevent entering

NO RUNS EXIST
There is no processed run to export data for.
6
6. Select the assay run you 3.3.Export Data
want to export by pressing no Run: (34) 090503 08:57
until the run appears, then press
yes.

7. Insert a USB memory or a 3.3.Export Data

diskette, or connect an external INSERT MEDIA AND PRESS ENTER
USB hard drive, and press enter.

NOTE! Use only one of the USB ports on the

front at a time.

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Assay Run Data Evaluation Phadia 100 - User Manual

Messages that can occur

MEDIA IS FOR OTHER INSTRUMENT

The USB memory, external USB hard drive or diskette is labeled with another
instrument Id. Data can only be exported to media labeled with the same
instrument Id.
MEDIA ERROR, ABORT?
The USB memory, external USB hard drive or diskette is not formatted or it is
damaged. Format the media or change it. Press no to continue or press yes to
abort.
MEDIA FULL, ABORT?
The USB memory, external USB hard drive or diskette is full. Delete old files or
change media. Press no to overwrite data or press yes to abort.
DATA ON MEDIA, OVERWRITE?
Data is already stored on the USB memory, external USB hard drive or diskette.
Press yes to overwrite data or press no to change the USB memory, external
USB hard drive or diskette.
MEDIA NOT INSERTED, ABORT?
Insert a USB memory or a diskette, or connect an external USB hard drive. Press
no to continue or press yes to abort.
MEDIA WRITE-PROTECTED, ABORT?
Remove the write protection or change the USB memory, external USB hard
drive or diskette. Press no to continue or press yes to abort.

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Phadia 100 - User Manual Assay Run Data Evaluation

Import Data

Data can be imported from a USB memory, an external USB hard drive or a
diskette and then be evaluated.

1. In Prepare Run mode press

3.
Phadia 100 Ver.3.0
1.Prepare Run?
14:10:17 2
5

3
2. Press yes. Phadia 100 Ver.3.0 14:10:17
3.Data Evaluation?

3. Press yes if you want to 3.Data Evaluation

print the Patient Report, other- 1.Print Patient Report?
wise press no.

4. Press yes if you want to

print the Laboratory report,
3.Data Evaluation
2.Print Laboratory Report?
4
otherwise press no.

5. Press yes if you want to

import data, otherwise press
no.
3.Data Evaluation
4.Import Data? 5
6
6. Insert a USB memory or a 3.4.Import Data
diskette, or connect an external INSERT MEDIA AND PRESS ENTER
USB hard drive, and press en-
ter.

NOTE! Use only one of the USB ports on the

front at a time.

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Assay Run Data Evaluation Phadia 100 - User Manual

Messages that can occur

NO DATA ON MEDIA
There is no data stored on the USB memory, external USB hard drive or diskette.
MEDIA IS FOR OTHER INSTRUMENT
The USB memory, external USB hard drive or diskette is labeled with another
instrument Id. Data can only be imported to the same instrument as it was
exported from.
MEDIA ERROR, ABORT?
The USB memory, external USB hard drive or diskette is not formatted or it is
damaged. Change the media. Press no to continue or press yes to abort.
MEDIA NOT INSERTED, ABORT?
Insert a USB memory or a diskette, or connect an external USB hard drive. Press
no to continue or press yes to abort.

7. Select the assay run you

want to import by pressing no 3.4.Import Data
Run: (34) 090503 08:57
until the run appears, then press
yes.

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Phadia 100 - User Manual Assay Run Quality Control

Chapter 6 - Assay Run Quality Control

This chapter describes the actions in the
Quality Control mode

Quality Control 2
Print Log 3
Print Quality Control Log 3
Print Curve Control-Log 4

Edit Log 5
Edit Quality Control-Log 5 6
Edit Curve Control-Log 6

Print Calibrators 8
Edit Calibrators 9
Set Active Calibrators 9
Accept Calibrators 10
Edit Calibrator Point 11
Export Quality Control-Logs 12
Export Curve Control Logs 13
Export Calibrators 15

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Assay Run Quality Control Phadia 100 - User Manual

Quality Control

From this mode you can print, edit and export quality control-logs. You can also
deactivate and activate control points from this mode. Deactivated control
points will not be included in the calculation when the average and CV
(coefficient of variation) is calculated for the log. The last 100 determinations
will be stored. Response and acceptance of calibrators can be changed in this
mode. You can also export control and calibrator logs to the IDM software via
a USB memory, an external USB hard drive or a diskette.
How to define a quality control is described in chapter 2, Routine Assay Run.

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Phadia 100 - User Manual Assay Run Quality Control

Print Log

In this mode you can print quality control-logs and curve control-logs.

1. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17

press 4. 1.Prepare Run?

2. In Quality Control mode Phadia 100 Ver.3.0 14:10:17

press yes. 4.Quality Control?

3. Press yes to print the Log, 4.Quality Control 6

otherwise no. 1.Print Log?
You can choose between the
quality-log curve and the curve
control-log.

4. Press no until the method 4.1.Print Log

you want appears, then press Method: ImmunoCAP specific IgE 0-100?
yes.

Warnings that may prevent entering

CANNOT SELECT THIS METHOD

The selected method cannot be used for this operation.

Print Quality Control Log

1. In Print Log mode press 4.1.Print Log

no until the method you want Method: ImmunoCAP specific IgE 0-100?
appears, then press yes.

2. Press yes. 4.1.Print Log

1.Quality control-log?

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Assay Run Quality Control Phadia 100 - User Manual

Warnings that may prevent entering

NO QUALITY CONTROL-LOGS EXIST

There are no quality controls defined in the selected method.

3. Press no until the quality 4.1.1.Quality control-log [sIgE]

control-log you want appears, Quality ctrl-log: QC-1 t1?
then press yes.
The quality control-log will be
printed.
A new window may appear.
Select a lot number for the qual-
ity control, press enter.

Print Curve Control-Log

1. Press 2. 4.1.Print Log

1.Quality control-log?

2. Press yes. 4.1.Print Log

2.Curve control-log?

Warnings that may prevent entering

NO CURVE CONTROL-LOGS EXIST

There are no curve controls defined in the selected method.

3. Press no until the curve 4.1.2.Curve control-log [sIgE]

control you want appears, then Curve ctrl-log: CC-1?
press yes. The curve control-
log will be printed.

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Phadia 100 - User Manual Assay Run Quality Control

Edit Log

You can inactivate and activate points in the quality control and curve control
logs.

1. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17

press 4. 1.Prepare Run?

2. Press yes. Phadia 100 Ver.3.0 14:10:17

4.Quality Control?

3. In Print Log press 2. 4.Quality Control 6

1.Print Log?

4. Press yes. 4.Quality Control

2.Edit Log?

5. Press no until the method 4.2.Edit Log

you want appears, then press Method: ImmunoCAP specific IgE 0-100?
yes.

Warnings that may prevent entering

CANNOT SELECT THIS METHOD

The selected method cannot be used for this operation.

Edit Quality Control-Log

You can set the status to active or inactive for a specific QC control point. If you
change a point to the status inactive, this point will be marked inactive when the
log is printed and it will not be used in the calculation of mean and variation.

1. In Edit Log mode press 4.2.Edit Log

no until the method you want Method: ImmunoCAP specific IgE 0-100?
appears, then press yes.

2. Press yes. 4.2.Edit Log [sIgE]

1.Quality control-log?

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Assay Run Quality Control Phadia 100 - User Manual

Warnings that may prevent entering

NO QUALITY CONTROL-LOGS EXIST

There are no quality controls defined in the selected method.

3. Press no until the quality 4.2.1.Quality control-log [sIgE]

control-log you want appears, Quality ctrl-log: QC-1 t1?
then press yes.

4. Press no (or shift and no) 4.2.1.Quality control-log [sIgE]

until the quality control-log you QC-1: 090405 15:13 0.36
want appears, then press yes.
The control is identified by the
date and time when processed
and the concentration of the
log point.

5. Press no to change to "IN- 4.2.1.Quality control-log [sIgE]

ACTIVE". Confirm with yes. QC-1, 090405 15:13 ACTIVE?

Edit Curve Control-Log

You can set the status to active or inactive for a specific Curve Control point.
If you change a point to the status inactive, this point will be marked inactive
when the log is printed and it will not be used in the calculation of mean and
variation.

1. In the quality control-log 4.2.Edit Log [sIgE]

mode press 2. 1.Quality control-log?

2. Press yes. 4.2. Edit Log [sIgE]

2.Curve Control Log?

Warnings that may prevent entering

NO CURVE CONTROL-LOGS EXIST

There are no curve controls defined in the selected method.

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Phadia 100 - User Manual Assay Run Quality Control

3. Press no until the curve 4.2.2.Curve Control Log [sIgE]

control-log you want appears, Curve ctrl-log: CC-1?
then press yes.

4. Press no until the curve 4.2.2.Curve Control Log [sIgE]

control you want appears, then CC-1: 090405 14:29 0.71?
press yes.

5. Press no to change to "IN- 4.2.2.Curve Control Log [sIgE]

ACTIVE". Confirm with yes. CC-1, 090405 14:29 ACTIVE?

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Assay Run Quality Control Phadia 100 - User Manual

Print Calibrators

You can print calibration curve and data for selected calibrators.

1. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17

press 4. 1.Prepare Run?

2. Press yes. Phadia 100 Ver.3.0 14:10:17

4.Quality Control?

3. In Print Log press 3. 4.Quality Control

1.Print Log?

4. Press yes. 4.Quality Control

3.Print Calibrators?

5. Press no until the method 4.3.Print Calibrators

you want appears, then press Method: ImmunoCAP Specific IgE 0-100?
yes.

Messages that can occur

CANNOT SELECT THIS METHOD

The selected method cannot be used for this operation.

6. Press yes. 4.3.Print Calibrators [sIgE]

1.Specific Calibrators?

Warnings that may prevent entering

NO CALIBRATORS EXIST
There are no stored calibrators for the selected method.

7. Select the calibrators you 4.3.1.Specific Calibrators [sIgE]

want by pressing no until the sIgE calibrators: 090405 11:13 153?
ones you want turn up, then
press yes. The selected calibra-
tors curve and data are printed.

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Phadia 100 - User Manual Assay Run Quality Control

Edit Calibrators

You can press and set calibrators to be the active calibrators for a method. You
can also set the acceptance for calibrators to OK, FLAGGED and NOT OK.
There is also a password protected function where you can change the response
of calibrators.

1. In Prepare Run mode Phadia 100 Ver.3.0 14:10:17

press 4. 1.Prepare Run?

2. Press yes. Phadia 100 Ver.3.0

4.Quality Control?
14:10:17
6
3. In Print Log press 4. 4.Quality Control
1.Print Log?

4. Press yes. 4.Quality Control

4.Edit Calibrators?

5. Press no until the method 4.4.Edit Calibrators

you want appears, then press Method: ImmunoCAP Specific IgE 0-100?
yes.

Messages that can occur

CANNOT SELECT THIS METHOD

The selected method cannot be used for this operation.

Set Active Calibrators

Only one set of calibrators data can be active for a method at a specific
time.These active calibrators are then used in the assay runs you will evaluate
later (using curve controls only).

1. In Edit Calibrators mode 4.4.Edit Calibrators

press no until the method you Method: ImmunoCAP Specific IgE 0-100?
want appears, then press yes.

2. Press yes. 4.4.Edit Calibrators [sIgE]

1.Set Active Calibrators?

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Assay Run Quality Control Phadia 100 - User Manual

Warnings that may prevent entering

NO CALIBRATORS EXIST
There are no stored calibrators for the selected method.

3. Select the calibrators you 4.4.1.Set Active Calibrators [sIgE]

want by pressing no until the sIgE calibrators: 060405 11:13 15?
ones you want appear, then
press yes.

The selected calibrators will be set as active for the method you pressed.

Messages that can occur

CAL TOO OLD TO ACTIVATE

The selected calibrators have been inactivated too long to be set to active
(compared to max. reactivate time set in method).
CAL NOT ACCEPTED, PROCEED ANYWAY?
The selected calibrators do not have the acceptance level OK. If you press yes
the calibrators will be set to active, if you press no they will not be set to active.

Accept Calibrators
You can set the acceptance of calibrators to OK, FLAGGED or NOT OK. The
status OK indicates that the calibrators are suitable for evaluating an assay run.
The status FLAGGED indicates that one curve control was not within the limits
in the last run and now the calibration curve is uncertain for use. The status
NOT OK indicates that the calibrators cannot be used for evaluation. The
change of acceptance is permanent.

1. In Edit Calibrators mode 4.4.Edit Calibrators

press no until the method you Method: ImmunoCAP Specific IgE 0-100?
want appears, then press yes.

2. Press 2. 4.4.Edit Calibrators [sIgE]

1.Set Active Calibrators?

3. Press yes. 4.4.Edit Calibrators [sIgE]

2.Accept Calibrators?

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Phadia 100 - User Manual Assay Run Quality Control

Warnings that may prevent entering

NO CALIBRATORS EXIST
There are no stored calibrators for the selected method.

4. Select the calibrators you 4.4.2.Accept Calibrators [sIgE]

want by pressing no (or no and sIgE calibrators: 090405 11:13 15?
shift) until the ones you want
appear, then press yes.

5. Press no until the status 4.4.2.Accept Calibrators [sIgE]

you want appears and then
press yes. The status will be
Acceptance: OK?
6
set.

Edit Calibrator Point

This is a laboratory password protected function that means that you have to
log in with the laboratory password. You can change the response for a
calibrator point.

1. In the Edit Calibrators 4.4.Edit Calibrators [sIgE]

mode press 3. 1.Set Active Calibrators?

2. Press yes. 4.4.Edit Calibrators [sIgE]

3.Edit Calibrator Point?

Warnings that may prevent entering

NO CALIBRATORS EXIST
There are no stored calibrators for the selected method.

3. Select the calibrators you 4.4.3.Edit Calibrator Point [sIgE]

want by pressing no until the sIgE calibrators: 090405 11:13 15?
ones you want turn up, then
press yes.

The calibrators are identified by method, date and time for process and
calibration code.

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Assay Run Quality Control Phadia 100 - User Manual

4. Press no until the calibra- 4.4.3.Edit Calibrator Point [sIgE]

tor point you want appears and Point: CAL-0.35?
then press yes.

5. Type the new response of

4.4.3.Edit Calibrator Point [sIgE]
the calibrator point and press
Response: (2) 58.3_
enter.

If you want to recall the original response press enter and shift at the same time.

If you want to exit without any changes done press mode. The number of
replicates are displayed.

Export Quality Control-Logs

1. In the Export Quality con- 4.5.ImmunoCAP<->PC

trol-log mode press yes. 1.Export Quality control-logs?

2. Press no until the method 4.5.1.Export Quality control-logs

you want appears, then press Method: ImmunoCAP Specific IgE 0-100?
yes.

Warnings that may prevent entering

NO QUALITY CONTROL-LOGS EXIST

There are no QC logs for the selected method.
CANNOT SELECT THIS METHOD
The selected method cannot be used for this operation.

3. Insert a USB memory or a 4.5.1.Export Quality control-logs

diskette, or connect an external INSERT MEDIA AND PRESS ENTER
USB hard drive, and press en-
ter.

NOTE! Use only one of the USB ports on the

front at a time.

The quality control-log for the selected method will be exported.

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Phadia 100 - User Manual Assay Run Quality Control

Messages that can occur

MEDIA IS FOR OTHER INSTRUMENT

The USB memory, external USB hard drive or diskette is labeled with another
instrument Id. Data can only be exported to media labeled with the same
instrument Id.
MEDIA ERROR, ABORT?
The USB memory, external USB hard drive or diskette is not formatted or it is
damaged. Format the media or change it. Press no to continue or press yes to
abort.
MEDIA FULL, ABORT?
The USB memory, external USB hard drive or diskette is full. Delete old files or
change media. Press no to overwrite data or press yes to abort.
DATA ON MEDIA, OVERWRITE?
6
Data is already stored on the USB memory, external USB hard drive or diskette.
Press yes to overwrite data or press no to change the USB memory, external
USB hard drive or diskette.
MEDIA NOT INSERTED, ABORT?
Insert a USB memory or a diskette, or connect an external USB hard drive. Press
no to continue or press yes to abort.
MEDIA WRITE-PROTECTED, ABORT?
Remove the write protection or change the USB memory, external USB hard
drive or diskette. Press no to continue or press yes to abort.

Export Curve Control Logs

1. In the Export Quality con- 4.5.ImmunoCAP<->PC

trol-log press 2. 1.Export Quality control-logs?

2. Press yes. 4.5.ImmunoCAP<->PC

2.Export Curve control-logs?

3. Press no until the method 4.5.2.Export Curve control-logs

you want appears, then press Method: ImmunoCAP Specific IgE 0-100?
yes.

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Assay Run Quality Control Phadia 100 - User Manual

Warnings that may prevent entering

NO CURVE CONTROL-LOGS EXIST

There are no Curve Controls for the selected method.
CANNOT SELECT THIS METHOD
The selected method cannot be used for this operation.

4. Insert a USB memory or a 4.5.2.Export Curve control-logs

diskette, or connect an external INSERT MEDIA AND PRESS ENTER
USB hard drive, and press en-
ter.

NOTE! Use only one of the USB ports on the

front at a time.

The curve control-log for the selected method will be exported.

Messages that can occur

MEDIA IS FOR OTHER INSTRUMENT

The USB memory, external USB hard drive or diskette is labeled with another
instrument Id. Data can only be exported to media labeled with the same
instrument Id.
MEDIA ERROR, ABORT?
The USB memory, external USB hard drive or diskette is not formatted or it is
damaged. Format the media or change it. Press no to continue or press yes to
abort.
MEDIA FULL, ABORT?
The USB memory, external USB hard drive or diskette is full. Delete old files or
change media. Press no to overwrite data or press yes to abort.
DATA ON MEDIA, OVERWRITE?
Data is already stored on the USB memory, external USB hard drive or diskette.
Press yes to overwrite data or press no to change the USB memory, external USB
hard drive or diskette.
MEDIA NOT INSERTED, ABORT?
Insert a USB memory or a diskette, or connect an external USB hard drive. Press
no to continue or press yes to abort.
MEDIA WRITE-PROTECTED, ABORT?
Remove the write protection or change the USB memory, external USB hard
drive or diskette. Press no to continue or press yes to abort.

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Phadia 100 - User Manual Assay Run Quality Control

Export Calibrators

1. In the Export Quality con- 4.5.ImmunoCAP<->PC

trol-log press 3. 1.Export Quality control-logs?

2. Press yes. 4.5.ImmunoCAP<->PC

3.Export Calibrators?

3. Press no until the method 4.5.3.Export Calibrators

you want appears, then press Method: ImmunoCAP Specific IgE 0-100?
yes.

6
Warnings that may prevent entering

CANNOT SELECT THIS METHOD

The selected method cannot be used for this operation.
NO CALIBRATORS EXIST
There are no calibrators for the selected method.

4. Select the calibrators by

4.5.3.Export Calibrators
pressing no until the calibra-
sIgE calibrator: 090405 11:13 1A?
tors you want appears, then
press yes.

5. Insert a USB memory or a

4.5.3.Export Calibrators
diskette, or connect an external
INSERT MEDIA AND PRESS ENTER
USB hard drive, and press en-
ter.

NOTE! Use only one of the USB ports on the

front at a time.

The selected calibrators will be exported.

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Assay Run Quality Control Phadia 100 - User Manual

Messages that can occur

MEDIA IS FOR OTHER INSTRUMENT

The USB memory, external USB hard drive or diskette is labeled with another
instrument Id. Data can only be exported to media labeled with the same
instrument Id.
MEDIA ERROR, ABORT?
The USB memory, external USB hard drive or diskette is not formatted or it is
damaged. Format the media or change it. Press no to continue or press yes to
abort.
MEDIA FULL, ABORT?
The USB memory, external USB hard drive or diskette is full. Delete old files or
change media. Press no to overwrite data or press yes to abort.
DATA ON MEDIA, OVERWRITE?
Data is already stored on the USB memory, external USB hard drive or diskette.
Press yes to overwrite data or press no to change the USB memory, external USB
hard drive or diskette.
MEDIA NOT INSERTED, ABORT?
Insert a USB memory or a diskette, or connect an external USB hard drive. Press
no to continue or press yes to abort.
MEDIA WRITE-PROTECTED, ABORT?
Remove the write protection or change the USB memory, external USB hard
drive or diskette. Press no to continue or press yes to abort.

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Phadia 100 - User Manual Monthly Calibration

Chapter 7 - Monthly Calibration

This chapter describes the run and
acceptance of the monthly calibration

Concept 2
General Flow in Phadia 100 2
Acceptance of Calibration Curve Assay Runs 3
Acceptance of Assay Runs 4

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Monthly Calibration Phadia 100 - User Manual

Concept

Traditionally a complete set of calibrators has been run in each assay run. The
introduction of this integrated immunoassay instrument, comprising sample
and reagent pipetting, temperature control, washing and fluorometric measure-
ments, has enabled the use of stored calibration curves. The high reproducibility
of the reagents and the automated instrument allow established calibration
curves to be stored and used in following assay runs.
The reduced number of calibrators in each assay run allows more samples to be
run and the reagent cost per sample to be reduced. Also the effort to establish,
check and accept the calibration curve is reduced. The instrument will automati-
cally verify if the calibration curve or the curve controls are within the
preprogrammed limits and report if the curve was accepted in the actual assay
run or not.
NOTE! Accordingly, the calibration curve is run and stored the first time a
calibration code of reagents is to be used. In the following assay run, curve
controls are assayed to check the validity of the stored curve.

General Flow in Phadia 100

A calibration curve is established for each new lot number/calibration code of
conjugate and for some methods also ImmunoCAP. In subsequent assay runs,
the same combination of conjugate and ImmunoCAP must be used. The
obtained response curve is checked by the built-in control functions of the
instrument. If the response follows the defined rules for curve acceptance, the
curve is stored as active in the computer memory of the instrument.
For Total IgE, ECP, and Tryptase the calibration code is the combination of the
conjugate and the ImmunoCAP calibration code/lot number, each stated on
respective label. For all other methods the calibration code is connected to only
the conjugate calibration code. The calibration code is linked to the stored
calibration curve. In the following assay runs the stored curve is verified by
running only two determinations of curve controls. If the controls are within the
limits, the instrument will accept the assay run.
The stored calibration curve is valid for the specific calibration code for a
maximum time of 28 days, as long as the curve controls are within the limits.
A laboratory report is automatically printed when the assay run is ended
regardless whether the assay run is accepted by the software or not.
NOTE! It is always the decision of the responsible laboratory manager to accept
an assay run. Other assay performance parameters have to be taken into
consideration, for example the result of quality controls.

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Phadia 100 - User Manual Monthly Calibration

Acceptance of Calibration Curve Assay Runs

In Phadia 100 numerous functions are checked before the assay is judged by the
software as accepted or not. The instrument will automatically after each assay
self-check important functions; the assay blank and signal of calibration
controls, and the curve fitting. If all these functions have performed within the
specified limits, the assay is recommended to be accepted by the operator.
ImmunoCAP Specific IgE, ImmunoCAP Total IgE, ImmunoCAP Specific IgA,
ImmunoCAP Specific IgG and ImmunoCAP Specific IgG4 use a 5-parameter
logistic function to estimate the calibration curve while ECP, EliA IgA, EliA IgG,
EliA IgM. EliA Calprotectin and Tryptase use a 4-parameter logistic function.
These functions, also called Rodbard, normally use many iterations. The
parameters of the function are iteratively estimated until a good curvefit is
obtained.

Calibration Curve Assay and Interpretation of obtained Calibrator

Point Values

• If all replicates of the lowest calibrator point (second lowest in EliA IgG, EliA 7
IgA and Elia IgM) are discarded - The calibration curve will not be evaluated
and not set as active.
• One replicate is discarded - The calibration curve will be evaluated and set
as active.
• Two or three replicates are discarded - The calibration curve will be
evaluated but not set as active.
• More than three replicates are discarded - The calibration curve will not be
evaluated and not set as active.
• If the number of iterations exceeds 150 the calculation stops - The calibra-
tion curve is evaluated and the results will be calculated.

Upper RU Limit
RU
Ideal curve

Lower RU Limit

kU/l

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Monthly Calibration Phadia 100 - User Manual

Acceptance of Assay Runs

There might be occasions when, for example, the curve controls are outside the
expected concentration limits. Improper handling and storage of reagents, for
instance, will affect the performance negatively. There are two levels of limits
for acceptance of curve controls, inner and outer limits. (For assays using one
curve control in duplicates, each determination will be considered as compa-
rable to one curve control).

If one curve control is outside the inner limits but inside the outer limits, the
software will recommend the assay to be accepted.
If both curve controls are outside the inner limits in the same direction, i.e.
LOW*-LOW* or HIGH*-HIGH* the acceptance is depending on laboratory
routines and judge of QC samples.
If both curve controls are outside the inner limits in opposite directions or one
of two curve controls are out of the outer limit no results are calculated.
In these cases the calibration curve is flagged.
If one of the curve controls is out of limit in the next run the calibration curve
is deactivated. If curves controls are OK the calibrator curve change status to
OK.
Some methods use one curve control, which is run in duplicate. Other methods
use two curve controls, which are run in single replicate. This means that you
get two calibration curve results in every assay run.

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Phadia 100 - User Manual Monthly Calibration

Methods using two curve controls

The following results are possible in the first run for methods using two curve
controls:

CC1 CC2 Results/Curve status

1. Both curve OK OK Results calculated

controls are OK. Run accepted (OK)

2. One curve OK LOW* Results calculated

control is OK, the OK HIGH* Curve flagged
other is within the HIGH* OK
outer limits LOW* OK

3. Both curve LOW* LOW* Results calculated

controls are within HIGH* HIGH* Curve flagged
the outer limits in WARNING: Results must
the same direction. be judged - based on the
QC results 7

4. Both curve LOW* HIGH* No results calculated

controls are within HIGH* LOW* Curve flagged
the outer limits in
the opposite
direction.

5. One or both OK HIGH No results calculated

curve controls are OK LOW Curve flagged
out of the outer LOW OK
limits. LOW LOW
LOW LOW*
LOW HIGH
LOW HIGH*
LOW* LOW
LOW* HIGH
HIGH OK
HIGH LOW
HIGH LOW*
HIGH HIGH
HIGH HIGH*
HIGH* LOW
HIGH* HIGH

CC = Curve Control

NOTE! This symbol * means CHECK:

• The result for one curve control has been
observed outside the specified inner limits
• Indication of change in dose-response com-
pared with the calibration run.

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Monthly Calibration Phadia 100 - User Manual

If the calibration curve was flagged in the first run, the following results are
possible in the second run:

CC1 CC2 Results/Curve status

1. Both curve OK OK Results calculated

controls are OK. Curve flag removed (OK)

2. One curve OK LOW* Results calculated

control is OK, the OK HIGH* Stored curve deactivated
other is within the HIGH* OK (NOT OK)
outer limits LOW* OK

3. Both curve LOW* LOW* Results calculated

controls are within HIGH* HIGH* Stored curve deactivated
the outer limits in (NOT OK)
the same direction.
WARNING: Results must
be judged - based on the
QC results

4. Both curve LOW* HIGH* No results calculated

controls are within HIGH* LOW* Stored curve deactivated
the outer limits in (NOT OK)
the opposite
direction.

5. One or both OK HIGH No results calculated

curve controls are OK LOW Stored curve deactivated
out of the outer LOW OK (NOT OK)
limits. LOW LOW
LOW LOW*
LOW HIGH
LOW HIGH*
LOW* LOW
LOW* HIGH
HIGH OK
HIGH LOW
HIGH LOW*
HIGH HIGH
HIGH HIGH*
HIGH* LOW
HIGH* HIGH

CC = Curve Control
For more infomation about different kinds of errors see chapter 12, Error
Handling.

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Phadia 100 - User Manual Monthly Calibration

Methods using one curve control in duplicate

The following results are possible in the first run for methods using one curve
control in duplicate:

CC1 CC1 Results/Curve status

1. Both replicates OK OK Results calculated

are OK. Run accepted (OK)

2. One replicate is OK LOW* Results calculated

OK, the other is OK HIGH* Curve flagged
within the outer HIGH* OK
limits. LOW* OK

3. Both replicates LOW* LOW* Results calculated

are within the HIGH* HIGH* Curve flagged
outer limits in the WARNING: Results must
same direction. be judged - based on the 7
QC results

4. Both replicates LOW* HIGH* No results calculated

are within the outer HIGH* LOW* Curve flagged
limits in the oppo-
site direction.

5. One or both OK HIGH No results calculated

replicates are out OK LOW Curve flagged
of the outer limits. LOW OK
LOW LOW
LOW LOW*
LOW HIGH
LOW HIGH*
LOW* LOW
LOW* HIGH
HIGH OK
HIGH LOW
HIGH LOW*
HIGH HIGH
HIGH HIGH*
HIGH* LOW
HIGH* HIGH

CC1 = Curve Control 1

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Monthly Calibration Phadia 100 - User Manual

If the calibration curve was flagged in the first run, the following results are
possible in the second run:

CC1 CC1 Results/Curve status

1. Both replicates OK OK Results calculated

are OK. Curve flag removed (OK)

2. One replicate is OK LOW* Results calculated

OK, the other is OK HIGH* Stored curve deactivated
within the outer HIGH* OK (NOT OK)
limits LOW* OK

3. Both replicates LOW* LOW* Results calculated

are within the HIGH* HIGH* Stored curve deactivated
outer limits in the (NOT OK)
same direction.
WARNING: Results must
be judged - based on the
QC results

4. Both replicates LOW* HIGH* No results calculated

are within the HIGH* LOW* Stored curve deactivated
outer limits in the (NOT OK)
opposite direction.

5. One or both OK HIGH No results calculated

replicates are out OK LOW Stored curve deactivated
of the outer limits. LOW OK (NOT OK)
LOW LOW
LOW LOW*
LOW HIGH
LOW HIGH*
LOW* LOW
LOW* HIGH
HIGH OK
HIGH LOW
HIGH LOW*
HIGH HIGH
HIGH HIGH*
HIGH* LOW
HIGH* HIGH

CC1 = Curve Control 1

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Phadia 100 - User Manual Quality Assurance

Chapter 8 - Quality Assurance

This chapter describes the quality assurance
of Phadia 100 in vitro allergy, asthma and
autoimmunity testing

Introduction 2
Quality Assurance 3
Internal (day-to-day) Quality Control 4
Criteria for Control Samples 4
Quality Control of Specific IgE Assays 6
Quality control of other allergy, autoimmunity and asthma methods 7
Control Charts 7
Inspection of Control Charts 8
Interpretation of Control Charts 9

External Quality Assessment 11

Quality Club 11
Monthly Report 12 8
Summary Reports 13

Quality Control with Phadia 100 14

Control Charts 14
Quality Club 14

Expected Results 15
Quality Costs 16

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Quality Assurance Phadia 100 - User Manual

Introduction

Demands for better quality assessment and performance standards are growing.
Accurate cost-effective and reliable measurements of biochemical markers are
needed for making a good diagnosis.
Therefore health authorities throughout the world are striving to establish
performance and comparability standards. These ambitions require that diag-
nostic testing laboratories continuously assess their performance.
The laboratories performing in vitro tests can fulfill these demands and ensure
that correct results will be obtained by adapting a solid quality assurance
program in the laboratory.
This chapter gives the basis for how to introduce and use such programs in
laboratories using Phadia 100 for in vitro allergy, asthma and auto-immunity
testing.

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Phadia 100 - User Manual Quality Assurance

Quality Assurance

The American Society for Quality Control defines quality assurance as “all those
planned or systematic actions necessary to provide adequate confidence that a
product or service will satisfy given needs”. See Glossary and tables for
statistical quality control. Milwaukee, WI: American Society for Quality
Control, 1983.
Quality assurance of an in vitro allergy, asthma and autoimmunity test
procedure involves the following four steps:

1. Documentation and implementation of routines regarding:

• Sample handling (type, collection, identity, transportation,
storage, handling)
• Calibration and maintenance of equipment (instruments, pipettes)
• Reagents (ordering, transportation, storage, handling)
• Reporting of results

2. Training and confirmation of operators

8
The laboratory staff has to go through a training program before a new
method can be used for routine testing. The skill of an operator can be
monitored by precision experiments using the same design as in a
manufacturer's Directions for Use. If the coefficients of variation within and
between runs are of the same magnitude as in the Directions for Use, the
operator's skill is considered acceptable.

3. Control charts (day-to-day precision control)

The control samples are assayed in each run and the results are plotted
against run number (or time). Such a plot is generally called a run chart.

4. External quality assessment

Participation in external quality assessment programs is a prerequisite for
obtaining information about accuracy. The same samples are assayed by,
preferably, all laboratories using the same method.
For steps 1 and 2, Phadia AB can help and advise laboratories to ensure the
best performance. For steps 3 and 4, Phadia AB has developed special
products and procedures for the laboratories.

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Quality Assurance Phadia 100 - User Manual

Internal (day-to-day) Quality Control

Criteria for Control Samples

An ideal control sample should simulate the human serum matrix as closely as
possible with respect to biological proteins, lipids, pH, ionic strength and other
components.
Thus, it should be:
• Of human origin, preferably.
• Safe to use for the laboratory staff. The source material should be tested
negative by immunoassay for hepatitis B surface antigen, for antibodies to HIV
1, HIV 2 and for hepatitis C virus.
• Stable over time.
• Long lasting as it costs money and time to settle a new control sample in the lab.
• Preferably obtained with different concentrations of the analyte in order to be
able to check both sides of a decision level.
Phadia AB produces well-characterized and carefully controlled pools of human
serum samples.
Serum samples with extremely high total IgE levels or samples containing immune
complexes or interfering auto antibodies, all of which can interfere in a nonspecific
and irreproducible way in the analysis, are excluded (see Sample Controls).
ImmunoCAP Specific IgE Control is a serum pool containing allergen-specific IgE
antibodies against different allergens. Ready to use.
The wide range of allergen specific IgE antibodies available gives the user the
possibility of designing an optimal internal quality control program.
Each lot of ImmunoCAP Specific IgE Control has a shelf-life of two years, thus
allowing the laboratory to use the same control lot number over a long period of
time.
ImmunoCAP Specific IgE Negative Control is a control sample, negative with
respect to allergen Specific IgE antibodies. Ready to use.
ImmunoCAP Specific IgE f1 Control is a serum pool containing allergen-specific
IgE antibodies against f1. Ready to use.
ImmunoCAP Total IgE Control LMH are human serum pools at three different
concentration levels; low, medium and high. Ready to use.
ImmunoCAP ECP Control is a lyophilized human serum at one concentration
level.
ImmunoCAP Specific IgG Control LMH are human serum pools at three different
concentration levels; low, medium and high. Ready to use.
ImmunoCAP Specific IgG/IgG4 i1 Control H is human serum pools at a high
concentration level. Ready to use.
ImmunoCAP Specific IgG/IgG4 Control L is human serum pools at a low
concentration level. Ready to use.

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Phadia 100 - User Manual Quality Assurance

ImmunoCAP Gliadin IgA Control H are human serum pools at a high concentration
level. Ready to use.
ImmunoCAP Gliadin IgA/IgG Control L are human serum pools at a low
concentration level. Ready to use.
ImmunoCAP Gliadin IgG Control H are human serum pools at a high concentra-
tion level. Ready to use.
ImmunoCAP Gliadin IgA/IgG Control LMH are human serum pools at three
different concentration levels; low, medium and high. Ready to use.
ImmunoCAP Tryptase Control is a lyophilized human serum at one concentration
level.
ImmunoCAP Thyroid Peroxidase IgG Antibodies Control NLH are human serum
pools at three different levels; normal, low and high, to be used with ImmunoCAP
Specific IgG together with ImmunoCAP Thyroid Peroxidase ImmunoCAP.
ImmunoCAP Thyroglobulin IgG Antibodies Control NLH are human serum pools
at three different levels; normal, low and high, to be used with ImmunoCAP
Specific IgG together with ImmunoCAP Thyroglobulin ImmunoCAP.
EliA ANA Control positive, negative are human serum pools to be used with EliA
IgG together with ANA tests.
EliA ANCA/GBM Control positive, negative are human serum pools to be used
with EliA IgG together with ANCA/GBM tests. 8
EliA APS Control positive, negative is a human serum to be used with EliA IgG/
IgM/IgA together with APS tests.
EliA CCP Control positive, negative is a human serum to be used with EliA IgG
together with CCP tests.
EliA Celiac Control positive, negative are human serum pools to be used with EliA
IgG together with Celikey/Gliadin tests.
Origin:
• Human samples from allergic/autoimmune (positive) and non-allergic/non-
autoimmune (negative) donors.
Control:
• All sera have been tested by immunoassay and found negative for
hepatitis B surface antigen, hepatitis C and antibodies to HIV virus.
Characterization:
• All selected sera used for IgE testing are tested for total IgE and a broad panel
of relevant allergens. All sera used for IgA/IgG, ECP, Tryptase, and EliA IgG
testing are analyzed with the respective test method.
Phadia Diagnostic Sample Unit:
• All sera are stored in Phadia Diagnostic Sample Unit, which has over 25,000
characterized serum samples. This allows for the pooling of sera for specific
control purposes. It also enhances continuity with our internal quality assur-
ance and uniformity of our products.

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Quality Assurance Phadia 100 - User Manual

Quality Control of Specific IgE Assays

At least two or three of the most frequently used allergens in the laboratory should
be monitored. ImmunoCAP Specific IgE Negative Control should be used to
control the low end of the assay measuring range.
In each assay run, the above selected allergens are included in sets of single
determinations in every run of patient tests. The results are plotted in a control
chart.
The ranges, for ImmunoCAP Specific IgE Control, mean ±2 SD and mean ±3 SD
for each allergen, from approx. 20 determinations are calculated. For a well
functioning assay, 95% and 99%, respectively, of all the following observations
should fall within the calculated ranges as long as the same lot of ImmunoCAP
Specific IgE Control is used. The mean value for each allergen should fall within
the range given in the kit insert. The package insert values are calculated from
repeated analysis of the control sample using different production lots of
reagents and ImmunoCAP per allergen. The results for ImmunoCAP Specific
IgE Negative Control should all be negative (<0.35 kUA/l).

Preferable way to run QC

Example of ImmunoCAP Specific IgE Control insert, revised March 2006

ImmunoCAP Specific IgE

Vial lot Number/Numéro de lot/Chargennr./Batch nummer/Lotto n./Lote número/Lot nummer/Número do
lote do frasco: BNMAB

Allergen/Allergéne/ Range/Gamme/
Allergen/Allergen/ Bereich/Område/
Allergene/Alergeno/ Range/Rango/
Allergen/Alergénio Gränsvärde/Intervalo
kUA/l

d1 D. pteronyssinus 9.8 - 18
e1 Cat dander 14 - 25
f14 Soya bean 5.3 - 10
g6 Phleum pratense 14 - 26
m6 Alternaria alternata (A. tenuis) 5.3 - 10
t3 Betula verrucosa 4.8 - 8.9
w1 Ambrosia elatior 10 - 19

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Phadia 100 - User Manual Quality Assurance

Quality control of other allergy,

autoimmunity and asthma methods
Controls of preferably different concentration levels are used. Sets of control
samples are included in each run.
Minimum 20 results per control sample are collected from different runs and the
mean values ±2 SD and ± 3 SD are calculated and used in the control charts.

Preferable way to run QC

Use the minimum- and maximum-range values given in the Directions for Use
for the Quality Control, or for EliA on the package certificate. Run a minimum
of 20 assay runs to get the mean for the expected value and expected standard
deviation in the Quality Control log. Now you can use these obtained values for
expected concentration and standard deviation. It is recommended to use 3 as
the standard deviation limit.
The mean value and SD should be recalculated with regular intervals similar to
ImmunoCAP Specific IgE Control.
The obtained mean value for each control sample of ImmunoCAP Gliadin IgA/
IgG Control LMH and ImmunoCAP Specific IgG Control LMH should fall
within the range given in the package insert. 8
For EliA ANA Control, EliA ANCA/GBM Control, EliA CCP Control, EliA APS
Control and EliA Celiac Control the ranges are given on the package certificate.
For ImmunoCAP Total IgE Control LMH, ImmunoCAP ECP Control,
ImmunoCAP Tryptase Control, ImmunoCAP TG IgG Antibodies Control,
ImmunoCAP TPO IgG Antibodies Control, ImmunoCAP Specific IgE f1
Control, ImmunoCAP Specific IgG/IgG4 i1 Control H, ImmunoCAP Specific
IgG/IgG4 Control L, ImmunoCAP Gliadin IgA Control H, ImmunoCAP Gliadin
IgA/IgG Control L and ImmunoCAP Gliadin IgG Control H the ranges are given
on the vial label.

Control Charts
A control chart is used to detect deviations from “normal” performance.
Consequently there is a need for rules which, if transgressed, inform the
operator that the performance is out of control. The rules are often in the
form of control limits inserted in the control charts.To discover a systematic
error, a control rule should be based on a number of consecutive runs. For
changes occurring occasionally, only the actual run needs to be considered.

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Quality Assurance Phadia 100 - User Manual

Example of Control Chart

+3S D
16

+2S D
15

11
-2 S D

10
-3 S D

A control chart is constructed by plotting observed values of control samples

from each test occasion in a diagram. After collecting sufficient observa-
tions, a statistical calculation is made and control limits of usually mean ±2
SD and ±3 SD are inserted.

Inspection of Control Charts

The assay is accepted when the control observations are evenly distributed
around the mean value line and within control limits, ±2 SD. Results outside this
range, but inside ±3 SD should act as a “warning signal” and a check of
instruments and routines should be made. Results outside ±3 SD should result
in rejection of the assay run and a search for the sources of error.
Increase in random error is observed as an increased variation of the observed
values around the established mean value.

Example of random error

+3SD
16

+2SD
15

11
-2 S D

10
-3 S D

A systematic shift is illustrated below. Results change from one level to another.

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Phadia 100 - User Manual Quality Assurance

Example of systematic shift

+3SD
16

+2S D
15

11
-2 S D

10
-3 S D

A systematic drift is observed when control results from consecutive assay runs
gradually move away from the established mean value.
Possible causes are:
• Deterioration of reference reagents, quality control samples or enzyme
reagents
• Incorrect storage temperature
• Drift in system instrumentation 8

Example of systematic drift

+3SD
16

15
+2SD

11
-2 S D

10
-3 S D

Interpretation of Control Charts

The authors Westgard JO, Barry PL, Hunt MR and Groth T have in A multi-rule
Shewhart chart for quality control in clinical chemistry (Clin Chem 1981; 27:
493-501.) defined four control rules that can be used in connection with control
charts to judge whether an assay run should be accepted or not.
However, some of these rules change depending on the number of controls used
in each assay run. Therefore, these rules should only be used as guidelines when
interpreting control results and control charts. Experience and common sense
are still the best tools to be used.

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Quality Assurance Phadia 100 - User Manual

Rule 1: 12s means one observation exceeding x ± 2 SD. This provides a “warning”
and need for further inspection of control data in the assay run.
Rule 2: 13s means a run is not accepted if one result is outside x ± 3 SD. This rule
is mainly sensitive to random errors but can also detect large systematic errors.
Rule 3: 22s means a run is not accepted if two consecutive observations are
outside the same limit, either +2 SD or -2 SD. This does not apply only to the
same control sample. A run is rejected if two different control samples in the
same run behave as described above. This rule is sensitive to systematic errors.
Rule 4: R4s means a run is rejected when the difference between two control
samples within a run exceeds 4 SD, e.g., one control is outside +2 SD and the
other is outside -2 SD. This rule is sensitive to random errors.

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Phadia 100 - User Manual Quality Assurance

External Quality Assessment

Quality Club
Control charts give information about the precision and the pattern of variation
within a laboratory, but they give little information about trueness and no
information about the performance of a laboratory in relation to other
laboratories. To obtain such information the same samples are assayed by
laboratories using the same type of testing.
If the internal quality control shows low variation of results on a constant level,
this means the analytical procedure is stable. By comparing the concentration
levels obtained in the external quality assessment program, it is possible to judge
the accuracy of the measurements in the laboratory.

Relationship between internal quality control and external quality assessment

8
15

I n te r n a l q u a l it y c o n t r o l E x te r n a l
q u a li ty
14 a sse ssm e nt

" T r u e " v a lu e
12

Once low variation and good accuracy have been established for the analytical
procedure, it is essential to continuously monitor the performance using internal
and external quality control programs in order to maintain high-quality results.
Quality Club is an international quality assessment program for laboratories
using Phadia 100, Phadia 250 or Phadia 1000 for in vitro allergy, asthma and
autoimmunity testing. Today, more than 800 testing laboratories are active club
members. There are four programs in Quality Club which are similar: Specific
IgE and Total IgE, ECP and EliA Autoimmunity. Each program kit contains
reagents and material for four month use. It includes numbered control samples,
result cards, addressed envelopes and Directions for Use. Everything is distrib-
uted to the members.
Quality Club members can register their results directly on the Extranet and also
download reports through the Extranet. All that is needed is a username and a
password. For access to Extranet, please contact Phadia AB.

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Quality Assurance Phadia 100 - User Manual

Participation in the external quality assessment programs of Quality Club gives

the laboratory management and staff a possibility to compare their in vitro test
results with results obtained in other laboratories worldwide.
As there are no established true values for in vitro allergy, asthma and
autoimmunity testing, the common mean values obtained in Quality Club
programs are considered to be the best estimates of true values. Thus, partici-
pation in Quality Club is a tool to monitor the accuracy of the laboratory
measurement process for in vitro allergy, asthma and autoimmunity testing.

Monthly Report
Every month, Quality Club members assay the serum from one or two of the
vials in the same way as patient samples and send the results, completed on a
Result Card, to Phadia AB, or register through Extranet. The samples should be
put randomly in the assay and analysed according to the normal routine. In
return, the members receive a detailed, confindental report of their performance
and can compare their test with others. The well-documented information helps
them to monitor performance and secure high standards of accuracy and
reliability.
Specific IgE results for each of the three allergens requested per month are
analysed by use of established statistical methods. The results are presented in
histograms with a class interval depending on the concentration level (see
histogram). Results outside ±3.5 SD are summarized in white bars. Results for
EliA Autoimmunity are presented in the same way as Specific IgE.
Results for Total IgE and ECP for each of the two serum samples are put together
using the same statistical methods as for Specific IgE. The results are presented
in a format similar to Specific IgE in order to facilitate the interpretation.
The monthly report is based on a computer analysis of the assay results. These
results are given as concentrations, percent deviation from common means and
deviation scores. In the histograms, the bars containing these laboratory results
are black.
The use of deviation score makes it possible to compare different allergens and
different concentration levels in spite of only single determinations. It provides
a standardized measure of the deviation of a laboratory in relation to the
performance of the group of laboratories. The deviation score is calculated as
shown below.

Example:
Common mean 28.8
Standard deviation 2.52
Lab result 31.32
Deviation score 31.32 - 28.8
= 1.0
2.52

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Phadia 100 - User Manual Quality Assurance

Results from all labs Cat dander (e1)

N (except outliers) 525 No of participating labs: 530
Median 28,9 kUA/l
Mean 28,8 kUA/l 25

SD 2,52 kUA/l
20
CV 8,74 %

Percent of all labs

Mean - 2 SD 23,8 kUA/l 15

Mean + 2 SD 33,9 kUA/l

Your results 29,8 kUA/l 5

Deviation from mean 3,34 %

Deviation score 0,38 0

Conc. of Specific IgE (kUA/l)

Summary Reports
In addition valuable summaries, called Summary reports are sent out after each
4-month cycle covering the last three cycles (12 month).
A 12 monthly trend statistics reflecting the long-term method performance in
8
the laboratory is also distributed. These data helps the laboratories to maintain
test procedures or improve them where necessary. They provide timely signals
of system errors, calibration problems or can indicate a need to improve
technican training.
For each laboratory the report is based on at most 36 (12x3) observations for
Specific IgE and EliA Autoimmunity, and 24 (12x2) observations for Total IgE
and ECP.
Any questions regarding the interpretation of the summary reports, please
contact your local sales office or Phadia AB.

Time Trend Plot

3
Deviation Score

2
Allergen 1
1

0
Allergen 2
-1

-2 Allergen 3
-3

-4
200501 200502 200503 200504 200505 200506 200507 200508 200509 200510 200511 200512

Month

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Quality Assurance Phadia 100 - User Manual

Quality Control with Phadia 100

Control Charts
The instrument software program uses control charts to monitor internal
quality control. There are two ways to define the limit lines.
When a new quality control sample is used, no expected values obtained in the
laboratory are available. In this case the ranges given in the package insert may
be used.
When about 20 or 30 observations have been collected, the laboratory mean and
SD should be used for the new control limits.
For further information see chapter 6, Assay Run Quality Control or
chapter 10, Printouts.

Quality Club
A special function for Quality Club sample requests and result card printout is
available.

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Phadia 100 - User Manual Quality Assurance

Expected Results

All in vitro allergy, asthma and autoimmunity testing are immunodiagnostic

procedures. For such procedures it is not possible to obtain the %CV in the same
range as for “classical” clinical chemistry analytes like sodium, glucose, etc. in
external quality assessment programs.
For most immunodiagnostic procedures, such programs normally give CV in
ranges of 10 to 15%. Normally only one, mostly well-defined molecule is
handled. For this molecule are also international reference preparations avail-
able.
For Total IgE, the WHO international reference preparation is the basis for all
calibrations. Thus Total IgE tests are comparable to other immunodiagnostic
tests from external quality assessment program point of view.
For Specific IgE the situation is somewhat different. The allergen preparations
used are of biological origin with no international reference preparations
available. They consist of a complex mixture of many different protein
components. As an example, peanut allergen consists of 25 different major and
minor allergenic components. There are many possibilities for batch-to-batch 8
variation of the allergen source material (natural variation).
These complex mixtures must be handled in a way to allow reproducibility
throughout the whole production process in order to secure high-quality test
results.
Although the process involves such complex mixtures, laboratories in more
than 10 different countries, use different production lots of allergen ImmunoCAP,
they obtain only slightly higher coefficients of variation in the Quality Club
program than for other immunodiagnostic procedures.
External quality assessment programs involving different specific IgE methods
show Phadia 100 to be the most robust user-independent and reproducible
specific IgE test on the market.

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Quality Assurance Phadia 100 - User Manual

Quality Costs

It is important to understand that the concept of quality costs is broader than the
cost of quality control. Without this basic understanding, the only costs
considered will be the costs associated with day-to-day quality control and
external quality assessment. Keep in mind that without any quality control
efforts the laboratory will have higher-quality costs and products and services
of lower quality. With a solid quality assurance program implemented in the
laboratory, the costs of inadequate quality will decrease and the quality of
products and services will increase.
RJ. Elin described the different components of quality costs in clinical labora-
tories in his book Elements of cost management for quality assurance. College
of American Pathologists 1980; 34: 182-3, 194.
Costs of securing good quality:
• Prevention costs: “expenses for developing, using and improving a planned
quality control program.” Examples are training, calibration and mainte-
nance.
• Appraisal costs: “expenses for the operation and maintenance of an internal
(intra-laboratory) quality assurance program and an external (inter-labora-
tory) quality assurance program.” Examples are inspection and quality
control.
Costs of inadequate quality:
• Internal failure costs: “expenses for reworking and/or discarding an entire
batch of specimen results or an individual specimen due to some element of
improper processing that leads to an erroneous result.” Examples are
repeated runs and repeated work efforts.
• External failure costs: “expenses for the investigation of all inquiries by the
physician or patient consumer as a result of the inability of the laboratory
result (or lack of result) to help solve the patient care problem.” Examples
are complaints, service and repeat requests.

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Phadia 100 - User Manual Methods, Test Panels, Article Management

Chapter 9 - Methods, Test Panels, Article

Management
This chapter describes how to add, edit
and delete methods, test panels and
article management

5.Method Setup* 2
5.1.Add Method 4
5.2.Edit Method 5
5.2.1.General Parameters 5
5.2.2.Reagents** 7
5.2.3.Reference 7
5.2.4.Presentation** 11
5.2.5.Calculation** 12
5.2.6.Report type 13
5.2.7.Tests 16
5.2.8.Unknowns 20
5.2.9.Quality control 21

5.3.Delete Method 25
5.4.Print Method 26
5.4.1.Summary of Methods 26
9
5.4.2.Specific Method 26
5.4.3.All Methods 26

5.5.Export Method 27
5.5.1.Specific Method 27
5.5.2.All Methods 28

5.6.Import Method 29
6.2.Test Panels 30
6.2.1.Add Test Panel 30
6.2.2.Edit Test Panel 31
6.2.3.Delete Test Panel 33

6.6.Article Management 34
6.6.1.Add Article 34
6.6.2.Edit Article 35
6.6.3.Delete Article 36

6.11.3.Create Instrument Event Log 37

* Functions that are accessible after login with the laboratory password. See page 9.2.
** Functions that are not accessible for the default methods. It is recommended to contact your local Phadia
representative before using them also for own created methods.

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Methods, Test Panels, Article Management Phadia 100 - User Manual

5.Method Setup*

The Phadia 100 instrument offers several methods to use:

• ImmunoCAP Specific IgE
• ImmunoCAP Specific IgE 0-100
• ImmunoCAP Total IgE
• ImmunoCAP ECP
• ImmunoCAP Tryptase
• ImmunoCAP Specific IgA
• ImmunoCAP Specific IgG
• ImmunoCAP Specific IgG4
• EliA IgA
• EliA IgG
• EliA IgM
• EliA Calprotectin
Mode 5 in the Menu Structure is the Method Setup. You have to login with the
laboratory password (the password at delivery is "unicap").
To get to Method Setup do the following:

1. In Install/Service mode 6.Install/Service

press yes. 1.Login/Logout?

2. Press yes. 6.1.Login/Logout

1.Login?

3. Type the laboratory pass- 6.1.1.Login

word. Confirm this step with Password:
enter.

A message occurs which tells 6.1.Login/Logut

you that you are logged in. LOGGED IN

4. Press the mode key until Phadia 100 Ver.3.0 14:10:17

this display appears. Then press 1.Prepare Run?
5.

5. Press yes. Phadia 100 Ver.3.0 14:10:17

5.Method Setup?

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Phadia 100 - User Manual Methods, Test Panels, Article Management

6. Press yes. 5.Method Setup

1.Add Method?

In Method Setup you can:

5.1.Add Method
5.2.Edit Method
5.3.Delete Method
5.4.Print Method
5.5.Export Method
5.6.Import Method
You can find the whole Method Setup structure in chapter 2.
To navigate in Method Setup you can use the no and yes key, or if you know
the number of the function you just type it. Confirm each step with enter.
To select an alternative just press no until your choice is displayed. Confirm
with yes.
To go upwards in the menu, use mode.

Warnings that may prevent entering

9
REMOTE MODE SELECTED
The method Setup menu could not be reached since the instrument is set in PC-
remote mode.
If you are using the IDM software, use the PC to edit the methods.

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Methods, Test Panels, Article Management Phadia 100 - User Manual

5.1.Add Method

Here you can add new methods

USE EXISTING METHOD AS TEMPLATE
The easiest way to create a new method is to select one of the existing. Confirm
with yes.
The new method will get all parameter settings from the template method. Some
of the parameters can be changed in 5.2.Edit Method.
If you do not select a existing method all parameters get default values.
Name:
Type the name of the new method. Confirm with enter.
Abbreviated Name:
Type the abbreviated name, confirm with enter.

Message that can occur

SAME NAME ALREADY EXISTS

The same method name or abbreviation is used for another method. Please, type
another name.

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Phadia 100 - User Manual Methods, Test Panels, Article Management

5.2.Edit Method

You can select to edit presentations, calculation, report types, tests, unknowns
and Quality Control. These functions are described in the following sections.

NOTE! It is not possible to edit general para-

meters, reagents, presentations and calculations
in the default methods, only in the copied or
added ones.

NOTE! When you leave Edit Methods the display will ask
SAVE CHANGES TO METHOD?
By pressing yes all changes are stored.
Select 5.2.Edit method, then:
Select Method, confirm with enter.

9
Warnings that may prevent entering

CANNOT EDIT OR DELETE METHODS NOW

It is not possible to edit or delete methods while there is a run prepared or started.

5.2.1.General Parameters

5.2.1.1.Name**

Type a new name, maximum 30 characters. Confirm with enter.

5.2.1.2.Abbreviated name**

Type the abbreviated name, confirm with enter.

** This menu can not be reached for the default methods.

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Methods, Test Panels, Article Management Phadia 100 - User Manual

5.2.1.3.Allow Monthly calibration**

Select monthly calibration or not with the yes or no keys. Confirm with yes.

5.2.1.4.Cal code on ImmunoCAP/EliA Well

Select yes if batches of ImmunoCAP and conjugate has to be connected, for

example Total IgE, ECP och Tryptase.

5.2.1.5.Sequence number**

The Sequence number is 1 for ImmunoCAP methods and 2 for EliA Well
methods. Type the sequence number and confirm with enter.

5.2.1.6.Method priority**

If there are more than one method in a run, the Method prority decides in which
order they will be allocated. The lowest number will be allocated first. Type a
number (between 0 and 1000) and confirm with enter.

5.2.1.7.Diluent**

Define the identity of the diluent. Some methods (IgG/IgA) use a special diluent.

5.2.1.8.Diluent in pos. G

Press yes or no.

5.2.1.9.Action list number**

Action list number is used to define text in action lists for a certain method.

5.2.1.10.Reverse Calibrators**

The normal is to load calibrators from low to high. If you want the reverse order
select yes.

5.2.1.11.Default Cut-off Concentration**

Type the wanted default cut-off concentration and confirm with enter.

** This menu can not be reached for the default methods.

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Phadia 100 - User Manual Methods, Test Panels, Article Management

5.2.2.Reagents**
You can set parameters about the volumes, incubation times and the identity of
the reagents.
First step is to select type of reagent; Sample, Conjugate, Development Solution,
or Stop Solution. Confirm with yes.

5.2.2.1.Volume**

Type the new volume in μl, up to 4 digits. Confirm with yes.

5.2.2.2.Incubation time**

PARAMETER NOT RELEVANT.

Not to be changed.

5.2.2.3.Identity**

Type the identity. Confirm with enter.

5.2.3.Reference
9

5.2.3.1.Curve control

You can Add, Edit and Delete Curve Controls.

5.2.3.1.1.Add Curve ctrl**

You can add a new curve control. You will be prompted to enter some
parameter, see 5.2.3.1.2.1-9 Edit Curve Ctrl.

5.2.3.1.2.Edit Curve ctrl

Select Curve Control, confirm with enter.

5.2.3.1.2.1.Status**

Define if the curve control should be allocated (active) to new assay runs or not.
You can choose between ACTIVE and INACTIVE. Confirm with yes.

** This menu can not be reached for the default methods.

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5.2.3.1.2.2.Identity**

Type the identity of the curve control. Confirm with enter.

5.2.3.1.2.3.Test name**

Type the Test name of the ImmunoCAP, maximum 5 characters, that will be used
together with the curve control, confirm with enter.

5.2.3.1.2.4.Replicate**

Type the number of replicates (normally 1), confirm with enter.

5.2.3.1.2.5.Concentration**

Type the expected concentration, confirm with enter.

5.2.3.1.2.6.Expected s

Expected standard deviation. Type the figure, confirm with enter.

The inner and outer limits for the curve control are expressed as a factor that will
be multiplied with the expected standard deviation.

5.2.3.1.2.7.Limit s Inner

Inner limit of the concentration of the curve control. This factor will be multiplied
with the Expected s. The limit is for both above and below expected concentra-
tion.
Any change will be printed on the laboratory report.

5.2.3.1.2.8.Limit s Outer

Outer limit of the concentration of the curve control. This factor will be
multiplied with the Expected s. The limit is for both above and below expected
concentration.
Any change will be printed on the laboratory report.

5.2.3.1.2.9.Log start date

Type the log start date in the displayed format (year-month-day). Confirm this
step with enter.
Any change will be printed on the laboratory report.

** This menu can not be reached for the default methods.

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Phadia 100 - User Manual Methods, Test Panels, Article Management

5.2.3.1.3.Delete Curve ctrl**

Select the Curve Control you want to delete by pressing no until it appears, then
press yes.
You will be prompted to
PRESS ENTER TO DELETE CURVE CTRL.
Press enter and the display confirms
CURVE CONTROL DELETED.

5.2.3.2.Calibrators

5.2.3.2.1.Test name**

The Test name of the ImmunoCAP to be used for the calibration curve.

5.2.3.2.2.Age until warning

Age until warning:

Type in the maximum number of days a curve is valid. If the number of days has
been exceeded it should not be used. Warning will be given during Create Assay
run and on the Laboratory Report.
Age until pre-warning:
9
Type some days lower than the previous, to get a warning in advance, that it is
time to run a new calibration curve.

5.2.3.2.3.Max. flagged time**

The maximum number of days a curve is allowed to be flagged (too old). When
it has exceeded that number of days it will be set to NOT OK in next assay,
regardless of the result.
It is set to 0 for all default methods and cannot be changed.

5.2.3.2.4.Max. reactivate time**

The maximum number of days a curve is allowed to be deactivated and once

more re-activated.
It is set to 0 for all default methods and cannot be changed.

5.2.3.2.5.Max. bad replicates**

If the number of replicates that are flagged by the norm-dose check exceeds this
number, no curve-fit will be done.

** This menu can not be reached for the default methods.

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5.2.3.2.6.Low RU on zero-point**

You can enable or disable this function. Disable for example when you run EliA
methods in order to avoid Low RU error.

5.2.3.2.7.Quotient Point

Define the default calibrator point to be used for calculating the quotient when
reporting results. Confirm by pressing enter.

5.2.3.2.8.Add Point**

Used to add a calibrator to the selected method.

Define identity, concentration**, replicate**, normal response, expected s,
limit s upper RU, limit s lower RU, limit s precision and limit s deviation.

5.2.3.2.9.Edit Point**

Here you can change some parameters for the calibrators. Select which
calibrator, confirm with yes.
You can change concentration**, replicate**, normal response, expected s,
limit s upper RU, limit s lower RU, limit s precision and limit s deviation.

5.2.3.2.10.Delete Point**

Select calibrator point to be deleted. Confirm with yes.

You will be prompted to
PRESS ENTER TO DELETE POINT.
Press enter and
POINT DELETED
is shown on the display.

5.2.3.3.Blank**

Select if the Blank should be subtracted or not.

** This menu can not be reached for the default methods.

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5.2.4.Presentation**
In this function you can change the presentation of results on the X and/or the
Y-axis.

5.2.4.1.X-axis**

Press the yes key to be able to change parameters of the X-axis of the calibration
curve graph.

5.2.4.1.1.Text**

Type the new text (up to 15 characters) and confirm with enter.

5.2.4.1.2.Scale**

Select
LOGARITHMIC
or
LINEAR
scale.
9
5.2.4.1.3.Unit**

Type the unit you want and press enter.

5.2.4.2.Y-axis**

Press the yes key to be able to change parameters of the Y-axis of the calibration
curve graph.

5.2.4.2.1.Text**

Type the new text (up to 15 characters) and confirm with enter.

5.2.4.2.2.Scale**

Select
LOGARITHMIC
or
LINEAR
scale

** This menu can not be reached for the default methods.

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Methods, Test Panels, Article Management Phadia 100 - User Manual

5.2.4.2.3.Unit**

Type the unit you want and press enter.

5.2.4.2.4.Fixed scale**

Select yes or no.

If yes enter min. and max. limits.

5.2.5.Calculation**
In this function you can change calculation-parameters.

5.2.5.1.Calculation type**

Select Curve-fit, confirm with enter.

You can select from Rodbard 5-parameter, Richards, Cut-off, Spline, Spline
(non-smooth), Rodbard 4-parameter.

5.2.5.2.Normal Weight**

A parameter that controls the curve-fit. Not to be changed.

5.2.5.3.Predicted Variance A**

A parameter that controls the curve-fit. Not to be changed.

5.2.5.4.Predicted Variance B**

A parameter that controls the curve-fit. Not to be changed.

5.2.5.5.Robust Weight**

A parameter that controls the curve-fit. Not to be changed.

5.2.5.6.Min. Coeff. of Correlation**

Lowest acceptable coefficiant of correlation to allow the curve to be drawn.

Default value is 0 (zero).

** This menu can not be reached for the default methods.

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Phadia 100 - User Manual Methods, Test Panels, Article Management

5.2.5.7.Zero-point

Here you define a curve with the lower part linear and the upper part curved.
Zero-point switch:
0 = Off
>0 = index for the calibrator where the curve switch from
linear regression to a logistic function.
Zero-point linear points: Number of calibrators to be included in the linear part.

5.2.5.8.Lowest concentration

Lowest concentration that will be reported. 0 (zero) means at lowest calibrator.

5.2.6.Report type
In this function you can change the cut-off and the reference curve.

5.2.6.1.Cut-off

Here the cut-off point is defined.

9
5.2.6.1.1.Cut-off point**

Type a number, confirm with enter.

5.2.6.1.2.Text below reference

Type the text you want below the reference, maximum 8 characters. Confirm
with enter.

5.2.6.1.3.Text above reference

Type the text you want below the reference, maximum 8 characters. Confirm
with enter.

5.2.6.2.Reference curve

In this function you can edit text for the reference curve and the different classes.

** This menu can not be reached for the default methods.

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5.2.6.2.1.Concentration unit**

Type the unit you want, confirm with enter.

5.2.6.2.2.Text below lowest

Type the text you want, confirm with enter.

5.2.6.2.3.Add Class border**

Define concentration and class text.

5.2.6.2.4.Edit Class border

Select class border, type the text for samples with results above.

Warnings that may prevent entering

MAX NO. OF CLASSES ALREADY USED

It is not possible to add another class border. All the available positions are filled.
NO CLASSES EXIST
There are no classes defined in the method.

5.2.6.2.5.Delete Class border**

Select class border, confirm with yes.

5.2.6.2.6.Quantitative Below

Type text for concentrations below lowest calibration point.

5.2.6.2.7.Quantitative Above

Type text for concentrations above highest calibration point.

5.2.6.2.8.Use Calc Quant Above

Select if the text for results above highest calibration point should be calculated
or not. Confirm with enter.

** This menu can not be reached for the default methods.

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Phadia 100 - User Manual Methods, Test Panels, Article Management

5.2.6.3.Cut-off 2 (for ASM class)

5.2.6.3.1.Text below lowest

Type text for below lowest cut-off 2/ASM class.

5.2.6.3.2.Add Class border**

Define limit and text for a new Class border.

5.2.6.3.3.Edit Class border

Select Class border, type new text for values above.

5.2.6.3.4.Delete Class border**

Select a cut-off 2/ASM Class border. Press yes to delete.

5.2.6.4.Extra Reference classes

It is possible to define 19 (2 - 20) more classes.

9
5.2.6.4.1.Text below lowest

5.2.6.4.2.Add Class border**

5.2.6.4.3.Edit Class border

5.2.6.4.4.Delete Class border**

5.2.6.5.Extra Cut-off 2 (or Extra ASM classes)

It is possible to define 19 (2 - 20) more cut-off 2/ASM classes.

5.2.6.5.1.Text below lowest

5.2.6.5.2.Add Class border**

** This menu can not be reached for the default methods.

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5.2.6.5.3.Edit Class border

5.2.6.5.4.Delete Class border**

5.2.7.Tests
In this function it is possible to add, edit, and delete tests, and to change report.

5.2.7.1.Add Test

Type a new test name, confirm with enter.

Warnings that may prevent entering

MAX NO. OF TESTS ALREADY USED

It is not possible to add any more tests.

Messages that can occur

SAME TEST NAME ALREADY EXISTS

The same test name is used for another test. Please, type another name.

Type the full name, confirm with enter.

Type the number of replicates (1 digit), confirm with enter.
Select report concentration, yes or no.
No means that no concentration is reported.
Type report class (0-20), confirm with enter.
Select if you want a cut-off to be reported, yes or no.
No means that no cut-off is reported.
Type Report cut-off 2 (0-20).
0 (zero) means: Do not report. Confirm with enter.
Select report quotient, YES, YES PERCENT, or NO. Confirm with yes.
Quotient is the ratio between a sample value and the class border.
The display tells you TEST ADDED.

** This menu can not be reached for the default methods.

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Phadia 100 - User Manual Methods, Test Panels, Article Management

5.2.7.2.Edit Test

Type the test name of the test you want to edit, confirm with enter.

Messages that can occur

ENTERED TEST DOES NOT EXISTS

The entered test does not exist. Please, check the spelling.

5.2.7.2.1.Test name

Type the test name, confirm with enter.

5.2.7.2.2.Full name

Type the full name, confirm with enter.

5.2.7.2.3.Replicate

Type the number of replicates (1 digit), confirm with enter. 9

5.2.7.2.4.Report concentration

Select report concentration, yes or no.

5.2.7.2.5.Report class

Type report class (0-20).

0 (zero) means: Do not report. Confirm with enter.

5.2.7.2.6.Report cut-off

Select if you want a cut-off to be reported, yes or no.

5.2.7.2.7.Report cut-off 2/Report ASM class

Type Report cut-off 2 (0-20).

0 (zero) means: Do not report. Confirm with enter.

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5.2.7.2.8.Report quotient

Select report quotient, YES, YES PERCENT, or NO. Confirm with yes.
Quotient is the ratio between a sample value and the class border.

5.2.7.2.9.Concentration unit**

5.2.7.2.10.Concentration factor**

5.2.7.2.11.Highest concentration**

5.2.7.2.12.Decimals for conc <10**

5.2.7.2.13.Use Lot Specific Code**

Select Lot Specific Code or not with the yes or no keys. Confirm with yes.

5.2.7.2.14.Dilution factor

Type a number between 1 and 999 for

PREDILUTED
or 1, 2, 5, 10, 20, 50 or 100 for
INSTRUMENT DILUTION
Confirm with enter.

5.2.7.2.15.Dilution method

Select
INSTRUMENT DILUTION or PREDILUTED
Confirm with yes.

5.2.7.2.16.Diluent**

Define the identity of the diluent. Some methods (IgG/IgA) use a special diluent.

5.2.7.2.17.Cut-off concentration*

Type a concentration. Confirm with yes.

* This menu can be reached if you are logged in with laboratory password.
** This menu can not be reached for the default methods.

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5.2.7.2.18.Emphasize on reports**

Select how the test shall be reported with the yes or no keys. Confirm with yes.

5.2.7.2.19.Quant Below undiluted

Type in text to be written on lab report. For undiluted tests below the curve.

5.2.7.2.20.Quant Above undiluted

Type in text to be written on lab report. For undiluted tests above the curve.

5.2.7.2.21.Quant Below diluted

Type in text to be written on lab report. For diluted tests below the curve.

5.2.7.2.22.Quant Above diluted

Type in text to be written on lab report. For diluted tests above the curve.

5.2.7.2.23.Diluent in pos. G

Press yes or no. 9

5.2.7.2.24.Quality Club Index

Not used.

5.2.7.2.25.Lower detection limit

5.2.7.3.Delete Test

Type the test name of the test you want to delete, confirm with enter.
The display tells you
TEST DELETED.

Messages that can occur

ENTERED TEST DOES NOT EXISTS

The entered test does not exist. Please, check the spelling.

** This menu can not be reached for the default methods.

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5.2.7.4.Change Report for All

In this function you can change report parameters for all tests within a method,
that have the same parameters.
To make the selection step through and define the parameters from Report
concentration to Report quotient.
After Report quotient you will get a message
XX MATCHING TESTS FOUND, CHANGE?
where XX is the number of matching tests.

Messages that can occur

NO MATCHING TESTS FOUND

There are no matching tests.

If you want to change one or more report paramaters for the matching tests,
press yes. You have to go through all the parameters again, change the one(s)
you want to change, and after pressing yes after Report quotient the display will
confirm
REPORTS CHANGED
NOTE! You can always leave the function by pressing mode.

5.2.8.Unknowns
You can define how to dilute, dilution factor and allowed variation of replicates.

5.2.8.1.Dilution method

Select
INSTRUMENT DILUTION or PREDILUTED
confirm with yes.

5.2.8.2.Dilution factor

Type a number between 1 and 999 for

PREDILUTED
or 1, 2, 5, 10, 20, 50 or 100 for
INSTRUMENT DILUTION
Confirm with enter.

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5.2.8.3.%CV limit**

Type the largest allowed %CV. This function will be disabled if you type 0.

5.2.9.Quality control
Here you define how you want controls to be handled in an assay. Once a control
is defined as Status ACTIVE in the method, the result will automatically be
logged. A total of 26 Quality Controls can be defined. For EliA all positive
controls are predefined.
Controls have to be defined before requests are typed in. Once preparation of
a run is started, changes in methods are not allowed.

Preferable way to run QC

5.2.9.1.Add QC 9

Warnings that may prevent entering

MAX NO. OF QUALITY CONTROLS ALREADY USED

It is not possible to add any more QC.

You have to define a lot of parameters, see 5.2.9.2.Edit QC for further

explanation.
The display will confirm with
QUALITY CONTROL ADDED
Recommendation:
If you are using Phadia AB controls, use minimum and maximum ranges and
leave a 0 for the expected concentration, expected standard deviation and limit
standard deviation. When you have at least 20 logged values, make a printout
of the Quality Control log. You will now get the calculated mean and standard
deviation for your measurements. Now edit Quality Control and use your
calculated mean as expected concentration, your calculated standard deviation
as expected standard deviation and 2 as limit standard deviation. Set minimum
and maximum ranges to 0.

** This menu can not be reached for the default methods.

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5.2.9.2.Edit QC

In the Edit mode it is possible to change status, identity, test name, replicate,
response, expected conc. and s, limit s, range minimum and maximum as well
as log start date and number.

Warnings that may prevent entering

NO QUALITY CONTROLS EXIST

There is no QC defined for the method.

Select the Quality Control you want to edit.

Select the parameter you want to edit.

5.2.9.2.1.Status

Select ACTIVE, MANUAL or INACTIVE: Confirm with yes.

Active means that it will be added in all assay runs. Inactive means that it will
not be added. Manual means that it will be added if you decide so when an assay
run is prepared.

5.2.9.2.2.Identity

Type identity. Confirm with enter.

Messages that can occur

SAME QUALITY CTRL IDENTITY ALREADY EXISTS

The identity is already used by another QC.

It is possible to use the same vial (= same identity) for different tests.

5.2.9.2.3.Test name

Type Test name. Confirm with enter.

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Phadia 100 - User Manual Methods, Test Panels, Article Management

Messages that can occur

ENTERED TEST DOES NOT EXIST

The test name does not exist for the method. Please, check the spelling.
SAME QC IDENTITY ALREADY EXISTS
The identity is already used by another QC.

5.2.9.2.4.Replicate

Type the number of replicates. Confirm with enter.

5.2.9.2.5.%CV limit resp

Type the maximal allowed % CV. Confirm with enter.

Typing 0 (Zero) means that the function is deactivated.

5.2.9.2.6.Expected conc

Type the expected concentration. Confirm with enter.

Typing 0 (Zero) means that the function is deactivated. 9

5.2.9.2.7.Expected s

Type the expected standard deviation. Confirm with enter.

Typing 0 (Zero) means that the function is deactivated.

5.2.9.2.8.Limit s

Type the maximal allowed standard deviation. Confirm with enter.

Typing 0 (Zero) means that the function is deactivated.

5.2.9.2.9.Range minimum

Type the lowest allowed concentration. Confirm with enter.

Typing 0 (Zero) means that the function is deactivated.

5.2.9.2.10.Range maximum

Type the maximal allowed concentration. Confirm with enter.

Typing 0 (Zero) means that the function is deactivated.

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5.2.9.2.11.Log start date

Type the the first date you want the QC to be included in the print-out. QC before
that date will not be printed.
Use the format year-month-day.
This function is not present in 5.2.9.1.

5.2.9.2.12.Lot number

Type the Lot number. Confirm with enter.

5.2.9.2.13.Predilution factor

Type the Dilution factor. Confirm with enter.

5.2.9.2.14.Instr. dilution factor

1, 2, 5, 10, 20, 50 or 100. Confirm with enter.

5.2.9.2.15.Type of QC

Select either Concentration, Quotient or qualitative. Confirm with enter.

5.2.9.2.16.Order

Type the allocation order for QC samples. Confirm with enter.

5.2.9.3.Delete QC

Warnings that may prevent entering

NO QUALITY CONTROLS EXIST

There is no QC defined for the method.

Select the QC you want to delete. Confirm with yes.

The display will prompt you to
PRESS ENTER TO DELETE QUALITY CONTROL.
Press enter and the display show
QUALITY CONTROL DELETED.

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Phadia 100 - User Manual Methods, Test Panels, Article Management

5.3.Delete Method

Select Method, confirm with yes.

The display will prompt you to
PRESS ENTER TO DELETE METHOD
Press enter, and you will get the message
METHOD DELETED
If you try to delete a default method the display shows
ILLEGAL OPERATION ON DEFAULT METHOD

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5.4.Print Method

In the Print Method mode it is possible to print summary, specific method or

all method. See chapter 10, Printout, for examples of the printing lists.

5.4.1.Summary of Methods
Selecting Summary of methods will give you a list of all methods that are defined
in the actual Phadia 100.

5.4.2.Specific Method
Select a method, confirm with yes.
All parameters for the selected method will be printed.

5.4.3.All Methods
Selecting All methods will give you a list of all parameters of all defined methods.

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Phadia 100 - User Manual Methods, Test Panels, Article Management

5.5.Export Method

In the Export Method mode it is possible to export methods to a USB memory,

an external USB hard drive or a diskette to store the data or distribute to another
instrument.

5.5.1.Specific Method

NOTE! Use only one of the USB ports on the

front at a time.

Select method, confirm with yes.

You will be prompted to
INSERT MEDIA AND PRESS ENTER
Press enter.

Messages that can occur

9
MEDIA ERROR, ABORT?
The USB memory, external USB hard drive or diskette is not formatted or it is
damaged. Format the media or change it. Press no to continue or press yes to
abort.
MEDIA FULL, ABORT?
The USB memory, external USB hard drive or diskette is full. Delete old files or
change media. Press no to overwrite data or press yes to abort.
DATA ON MEDIA, OVERWRITE?
Data is already stored on the USB memory, external USB hard drive or diskette.
Press yes to overwrite data or press no to change the USB memory, external
USB hard drive or diskette.
MEDIA NOT INSERTED, ABORT?
Insert a USB memory or a diskette, or connect an external USB hard drive. Press
no to continue or press yes to abort.

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MEDIA WRITE-PROTECTED, ABORT?

Remove the write protection or change the USB memory, external USB hard
drive or diskette. Press no to continue or press yes to abort.

5.5.2.All Methods
After selecting All methods you will be prompted to
INSERT MEDIA AND PRESS ENTER

NOTE! Use only one of the USB ports on the

front at a time.

Press enter.

Messages that can occur

MEDIA ERROR, ABORT?

The USB memory, external USB hard drive or diskette is not formatted or it is
damaged. Format the media or change it. Press no to continue or press yes to
abort.
MEDIA FULL, ABORT?
The USB memory, external USB hard drive or diskette is full. Delete old files or
change media. Press no to overwrite data or press yes to abort.
DATA ON MEDIA, OVERWRITE?
Data is already stored on the USB memory, external USB hard drive or diskette.
Press yes to overwrite data or press no to change the USB memory, external USB
hard drive or diskette.
MEDIA NOT INSERTED, ABORT?
Insert a USB memory or a diskette, or connect an external USB hard drive. Press
no to continue or press yes to abort.
MEDIA WRITE-PROTECTED, ABORT?
Remove the write protection or change the USB memory, external USB hard
drive or diskette. Press no to continue or press yes to abort.

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5.6.Import Method

In this mode it is possible to import methods from a USB memory, an external

USB hard drive or a diskette.
After selecting Import Method the display will prompt you to
INSERT MEDIA AND PRESS ENTER

NOTE! Use only one of the USB ports on the

front at a time.

Select method from the USB memory, the external USB hard drive or the diskette.

Messages that can occur

NO METHODS EXISTS
There are no methods on the USB memory, external USB hard drive or diskette.
9
"NAME" METHOD NOT SIMILAR, UPDATE?
The selected method on the USB memory, external USB hard drive or diskette
has the same name as a method already used in the instrument, but one or more
parameters in the methods differs. If you press yes the method imported will
overwrite the method in the instrument. If you press no the method is not
imported.
NO DATA ON MEDIA
There is no data stored on the USB memory, external USB hard drive or diskette.
MEDIA ERROR, ABORT?
The USB memory, external USB hard drive or diskette is not formatted or it is
damaged. Change the media. Press no to continue or press yes to abort.
MEDIA NOT INSERTED, ABORT?
Insert a USB memory or a diskette, or connect an external USB hard drive. Press
no to continue or press yes to abort.

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Methods, Test Panels, Article Management Phadia 100 - User Manual

6.2.Test Panels

If you want to create an assay run set up for repeated use, you can create test
panels. You can add a maximum of 50 test panels with 46 tests each. A panel
can consist of up to 4 methods. Some test panels comes predefined.

6.2.1.Add Test Panel

1. In Prepare Run mode se-

lect the number 6 key. You will
come to Install/Service mode.

2. In Install/Service mode
press 2.

3. In Test Panels mode select

the yes key. ImmunoCAP 100 Ver.3.0 14:10:17
1.Prepare Run?

4. Press yes.
ImmunoCAP 100 Ver.3.0 14:10:17
5. Type the name of the new 6.Install/Service?
test panel (up to five charac-
ters) and press the enter key.
The name cannot be the same 6.Install/Service
as a testname. 2.Test Panels?

6. Type the test name you 6.2.Test Panels

1.Add Test Panel?
want to add to the test panel
and press enter.
Press alt if you want to choose 6.2.1.Add Test Panel
another method. Enter Panel Name: _

7. If you press alt, choose a

method by pressing the key
below the name.
6.2.1.Add Test Panel
Enter Test: (sIgE) d1_
8. Type the number of
replicates you want and press
enter.

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9. Type another test name SELECT METHOD

(up to five characters) you want sIgE tIgE ECP sIgG sIgA Tryp
to add to the test panel. Con-
firm this step with enter.

6.2.1.Add Test Panel

Enter Replicate number:1

Messages that can occur

PANEL ALREADY EXIST 6.2.1.Add Test Panel

Enter Test: (sIgE) _
The identity is already used by another test panel.
TEST ALREADY ENTERED
The test has already been entered for this test panel.
ENTERED TEST DOES NOT EXIST
The entered test name does not exist, check the spelling.

6.2.2.Edit Test Panel

Go to 6.2.Test Panel (as described in the section Add Test Panel) and follow the
instructions below. 9
1. In the Test Panels mode 6.2.Test Panels
press 2. 1.Add Test Panel?

2. Press yes. 6.2.Test Panels

2.Edit Test Panel?

3. Press no until the test 6.2.2.Edit Test Panel

panel you want to edit appears. Select Panel: _
Press enter to select the test
panel you want to edit.

6.2.2.1.Add Test

4. Press yes if you want to 6.2.2.Edit Test Panel ["test panel"]

add a test to the test panel. 1.Add Test?

5. Type the test name you 6.2.2.1.Add Test ["test panel"]

want to add. Press enter to add Enter Test:(sIgE)
the test to the test panel. Press
alt if you want to choose an-
other method.

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6. If you press alt, choose a SELECT METHOD

method by pressing the key sIgE tIgE Phad ECP
below the name.

7. Type the number of repli- 6.2.2.1.Add Test ["test panel"]

cates you want and press en- Enter Replicate number: 1
ter.

8. Type another test name 6.2.2.1.Add Test ["test panel"]

you want to add to the test Enter Test:(sIgE)
panel. If you are done entering
tests press enter.

6.2.2.2.Delete Test

Go to 6.2.2.Edit Test Panel (as described in the section Add Test) and follow the
instructions below.

1. In the Edit Test Panel 6.2.2.Edit Test Panel ["test panel"]

mode press 2. 1.Add Test?

2. Press yes if you want to 6.2.2.Edit Test Panel ["test panel"]

delete a test from the test panel. 2.Delete Test?

3. Press no until the test you 6.2.2.2.Delete Test ["test panel"]

want to delete appears. Press Select Test:(sIgE) t3?
yes to delete the test from the
test panel.

4. Press enter to confirm

6.2.2.2.Delete Test ["test panel"]
that you want to delete the test
PRESS ENTER TO DELETE TEST
from the test panel.

Messages that can occur

PANEL ALREADY EXIST

The identity is already used by another test panel.
TEST ALREADY ENTERED
The test has already been entered for this test panel.
ENTERED TEST DOES NOT EXIST
The entered test name does not exist, check the spelling.

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6.2.3.Delete Test Panel

Go to 6.2.Test Panel (as described in the section Add Test Panel) and follow the
instructions below.

1. In the Test Panels mode 6.2.Test Panels

press 3. 1.Add Test Panel?

2. Press yes. 6.2.Test Panels

3.Delete Test Panel?

3. Press no until the test panel 6.2.3.Delete Test Panel

you want to delete appears. Select Panel:XXX?
Press enter to select the test
panel you want to delete.

4. Press enter if you want to 6.2.3.Delete Test Panel

delete the test panel. The dis- PRESS ENTER TO DELETE TEST PANEL
play shows when the test panel
is deleted. 6.2.3.Delete Test Panel
TEST PANEL DELETED

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Methods, Test Panels, Article Management Phadia 100 - User Manual

6.6.Article Management

6.6.1.Add Article
If you are working with a bar code reader and you receive a new article, for
example a new allergen you need to add the article package code to the
instrument. You must be logged in with laboratory password if you want to work
with articles.

1. In Prepare Run mode se- ImmunoCAP 100 Ver.3.0 14:10:17

lect 6. 1.Prepare Run?

2. Press yes. ImmunoCAP 100 Ver.3.0 14:10:17

6.Install/Service?

3. In Install/Service mode 6.Install/Service

select 6. 1.Login/Logout?

4. In Article Management 6.Install/Service

mode select yes. 6.Article Management?

5. Press yes. 6.6.Article Management

1.Add Article?

6. Type the new article ID 6.6.1.Add Article

(up to three characters) and Article ID: 123
press enter.

7. Press no until the option 6.6.1.Add Article

you want appears and press Article type: UNDEFINED?
yes.

8. Type the article method 6.6.1.Add Article

(up to four characters) and press Article Method:_
enter to confirm this step.

9. Type the article text (up 6.6.1.Add Article

to 16 characters) and confirm Article Text:_
this step with enter.

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10. Type the article pack size 6.6.1.Add Article

(up to five numbers) and press Article Pack Size: 1_
enter to confirm this step.

11. Press enter. 6.6.1.Add Article

Bar-code param.1:

12. Press enter. 6.6.1.Add Article

Bar-code param.2:

13. The display shows that 6.6.1.Add Article

the the article is added. ARTICLE ADDED

6.6.2.Edit Article
Go to 6.6.Article Management (as described in the section Add Article) and
follow the instructions below.

1. In the Article Manage- 6.6.Article Management

ment mode press 2. 1.Add Article?

2. Press yes. 6.6.Article Management

2.Edit Article?
9
3. Type the ID of the article 6.6.2.Edit Article
you want to edit (up to three Article ID:_
numbers). Press enter to con-
firm this step.

4. Press no until the article 6.6.2.Edit Article

type you want appears. Then Article type: UNDEFINED?
press yes.

5. Type the new article 6.6.2.Edit Article

method over the old one (up to Article Method: ECP_
four characters) and confirm
this step with enter.

6. Type the new article text 6.6.2.Edit Article

over the old one (up to 16 Article Text: XXX_
characters) and confirm this
step with enter.

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7. Type the new article pack 6.6.2.Edit Article

size over the old one (up to five Article Pack Size: 4_
characters) and confirm this step
with enter.

8. Press enter. 6.6.2.Edit Article

Bar-code param.1:

9. Press enter. 6.6.2.Edit Article

Bar-code param.2:

10. The display shows that 6.6.2.Edit Article

the article is edited. ARTICLE EDITED

6.6.3.Delete Article
Go to 6.6.Article Management (as described in the section Add Article) and
follow the instructions below.

1. In the Article Manage- 6.6.Article Management

ment mode press 3. 1.Add Article?

2. Press yes. 6.6.Article Management

3.Delete Article?

3. Type the ID of the article 6.6.3.Delete Article

you want to delete and press Article ID:_
enter.

4. Press enter to confirm this 6.6.3.Delete Article

step. The display shows that PRESS ENTER TO DELETE ARTICLE
the article is deleted.
6.6.3.Delete Article
ARTICLE DELETED

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6.11.3.Create Instrument Event Log

Use this function at troubleshooting, when you need to create an instrument event
log on a USB memory, an external USB hard drive or a diskette.

1. In Prepare Run mode se- ImmunoCAP 100 Ver.3.0 14:10:17

lect 6. 1.Prepare Run?

2. Press yes. ImmunoCAP 100 Ver.3.0 14:10:17

6.Install/Service?

3. In Install/Service mode 6.Install/Service

select 11. 1.Login/Logout?

4. Press yes. 6.Install/Service

11.Export Debug Files?

5. In Export Debug Files 6.11.Export Debug Files

mode select 3. 1.Export Debug Log Files?

9
6. Press yes. 6.11.Export Debug Files
3.Create Instrument Event Log?

7. Please wait while the in- 6.11.3.Create Instrument Event Log

strument creates the file. PLEASE WAIT...

8. Insert a USB memory or a 6.11.3.Create Instrument Event Log

diskette, or connect an external INSERT MEDIA AND PRESS ENTER
USB hard drive, and press en-
ter.

NOTE! Use only one of the USB ports on the

front at a time.

Messages that can occur

MEDIA ERROR, ABORT?

The USB memory, external USB hard drive or diskette is not formatted or it is
damaged. Format the media or change it. Press no to continue or press yes to
abort.

12-3501-20/12 Page 9.37

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Methods, Test Panels, Article Management Phadia 100 - User Manual

MEDIA FULL, ABORT?

The USB memory, external USB hard drive or diskette is full. Delete old files or
change media. Press no to overwrite data or press yes to abort.
DATA ON MEDIA, OVERWRITE?
Data is already stored on the USB memory, external USB hard drive or diskette.
Press yes to overwrite data or press no to change the USB memory, external USB
hard drive or diskette.
MEDIA NOT INSERTED, ABORT?
Insert a USB memory or a diskette, or connect an external USB hard drive. Press
no to continue or press yes to abort.
MEDIA WRITE-PROTECTED, ABORT?
Remove the write protection or change the USB memory, external USB hard
drive or diskette. Press no to continue or press yes to abort.

9. Please wait while the in- 6.11.3.Create Instrument Event Log

strument writes to the USB PLEASE WAIT...
memory, external USB hard
drive or diskette.

You may need several diskettes to save all data. The instrument will then display
a message to insert additional diskettes.

10. When the instrument re- 6.11.Export Debug Files

turns to Create Instrument 3.Create Instrument Event Log?
Event Log, the USB memory,
external USB hard drive or dis-
kette is ready for use.

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Phadia 100 - User Manual Printouts

Chapter 10 - Printouts
This chapter describes printouts and
results as they are listed by the instrument

Description of All Printouts 2

Request List 3
Consumption List 4
Distribution List 5
Laboratory Report 6
Patient Report 10
Calibrators 11
Quality Control Log 13
Curve Control Log 15
Run Summary 16
Method Summary 16
Action List 17
Blank Report 17
FluoroC Run Report 18
Method Setup 19

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Printouts Phadia 100 - User Manual

Description of All Printouts

In this chapter you will find all the reports and lists that can be printed from the
instrument. Each printout is described in detail together with a copy of the
printout.
The following reports and lists can be printed from the instrument:
• Request List
• Consumption List
• Distribution List
• Laboratory Report
• Patient Report
• Calibrators
• Quality Control Log
• Curve Control Log
• Run Summary
• Method Summary
• Action List
• Blank Report
• FluoroC Run Report
• Method Setup
Laboratory Reports and Patient Reports can be customized as described in the
parts Laboratory Report and Patient Report.

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Phadia 100 - User Manual Printouts

Request List
The request list contains all the unknown sample identities and their requested
tests from the latest prepared assay run. To print this list select 1.2.Print Lists,
REQUEST option on the instrument.

REQUEST LIST
Run sequence number
Run number: 18
Date and time of the first entered Run created: 090508 16:15
request
Run origin: Instrument The identity of the unknown
sample requested in the run
Run origin:
Instrument The run was cre- S01
ated in the instru-
ment Name of the method used for the
ImmunoCAP Specific IgE 0-100 requested tests
PC Remote The run was cre-
1 fx1 (f13 f17 f18 f20 f36)
ated on a PC using
an external soft-
1 e3 Horse dander Name of the requested tests
ware such as IDM 1 t1 Box-elder
ImmunoCAP Total IgE
Number of replicates
1 a-IgE Total IgE

10
S02

ImmunoCAP Specific IgE 0-100

1 d2 D. farinae
Method version number
ImmunoCAP Total IgE
2 a-IgE Total IgE
Instrument serial number
0354, 090508 16:20, 2.3, 032
Date and time of printout

Software version number

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Printouts Phadia 100 - User Manual

Consumption List
The consumption list contains all the components with the amounts needed in
the prepared assay run. To print this list select 1.2.Print Lists, CONSUMP
option on the instrument.

CONSUMPTION LIST
Run sequence number
Run number: 18
Date and time of the first entered Run created: 090508 16:15
request Name of the group of
Run origin: Instrument components

Run origin:
CURVE CONTROL Name of the components, listed
Instrument The run was cre- by method and identity
tIgE CC-1 40 μl
ated in the instru-
ment tIgE CC-2 40 μl
Amount needed for each compo-
PC Remote The run was cre- nent in the run
ated on a PC using CALIBRATORS
IDM
sIgE CAL-0.35 80 μl
sIgE CAL-0.70 80 μl
sIgE CAL-3.50 80 μl
sIgE CAL-17.5 80 μl
sIgE CAL-50.0 80 μl
sIgE CAL-100 80 μl

SAMPLE
(not including dead volume, see User Manual)
S01 40 μl
Lot number for QC
S02 22 μl
tIgE QC1 40 μl AWNA9
Quality Controls as added in the
Number of replicates
method setup
ImmunoCAP
sIgE a-IgE 12 Calibration code of ImmunoCAP
tIgE a-IgE 5 A3
The stated reagent volume in-
REAGENT cludes the dead volume. Vials
(including dead volume) used for sIgE conjugate and de-
sIgE - Conjugate 900 μl velopment solution have a dead
tIgE - Conjugate 550 μl A3 volume of approximately 300 µl.
Development Solution 1250 μl This dead volume is added to the
volume needed for the assay run.
Stop Solution 17300 μl
The dead volume will not be con-
Software version number
Diluent 522 μl sumed.

Instrument serial number Calibration code of conjugate

0354, 090508 16:22, 2.3, 032
Date and time of printout
Method version number

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Phadia 100 - User Manual Printouts

Distribution List
This printout lists the components and where they are placed in the instrument.
To print this list select 1.2.Print Lists, DISTR option on the instrument.

Run origin:
Instrument The run was created
DISTRIBUTION LIST in the instrument
Run sequence number PC Remote The run was created
on a PC using IDM
Run number: 1
Date and time of the first entered
Run created: 090508 16:15
request
Run origin: Instrument
Calibration Code of conjugate

Position in Sample Carousel SAMPLE CAROUSEL In case of dilution, the dilution

A sIgE Conjugate 1P method is printed here.
B tIgE Conjugate 3C The dilution method could be:
E Development solution
H Stop solution Instr Instrument dilution
01 S01 Sample Pre 20 Pre Prediluted
Component allocated to this po-
sition, listed by method and iden- 02 S02 Sample
tity (unknown listed by identity 03 S02 Empty Instr 10 Dilution factor for prediluted
only) 04 sIgE CAL-0.35 Cal sample
05 sIgE CAL-0.70 Cal
06 sIgE CAL-3.50 Cal Dilution factor for instrument di-
Type of sample allocated to this 07 sIgE CAL-17.5 Cal
position: luted sample
08 sIgE CAL-50.0 Cal
Sample Unknown 09 sIgE CAL-100 Cal
sample 10 tIgE CC-1 Curve control 10
Cal Calibrator 11 tIgE CC-2 Curve control
Curve control Curve control 12 sIgE QC-2 Quality controlAVMAB
Quality control Quality control 13 tIgE QC-1 Quality controlAWNA9
sample 14 Diluent
Empty Empty tube Lot number for QC
(for dilution)
Diluent Diluent ImmunoCAP CAROUSEL
solution 01 sIgE a_IgE <- 04 CAL-0.35
02 sIgE a_IgE <- 04 CAL-0.35 Position in Sample Carousel from
03 sIgE a_IgE <- 05 CAL-0.70 which sample will be dispensed
04 sIgE a_IgE <- 05 CAL-0.70 into the ImmunoCAP position
Position in ImmunoCAP Carousel 05 sIgE a_IgE <- 06 CAL-3.50
06 sIgE a_IgE <- 06 CAL-3.50 Identity of component to dis-
ImmunoCAP allocated to the po- 07 sIgE a_IgE <- 07 CAL-17.5 pense into the ImmunoCAP posi-
sition, listed by method and test 08 sIgE a_IgE <- 07 CAL-17.5 tion
09 sIgE a_IgE <- 08 CAL-50.0
10 sIgE a_IgE <- 08 CAL-50.0
11 sIgE a_IgE <- 09 CAL-100
If methods use calibration codes
12 sIgE a_IgE <- 09 CAL-100
on ImmunoCAP, these will be
13 tIgE a-IgE <- 10 CC-1 3C
printed here
14 tIgE a-IgE <- 11 CC-2 3C
15 sIgE e1 <- 12 QC-2
16 tIgE a-IgE <- 13 QC-1 Dilution factors for sample
17 tIgE a-IgE <- 01 S01 20
Software version number 18 tIgE a-IgE <- 01 S02 100

Instrument serial number Method version number

0354, 090508 16:22, 2.3, 032
Date and time of printout

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Printouts Phadia 100 - User Manual

Laboratory Report
The laboratory report contains the results from one assay run. It is automati-
cally printed after an assay run has been processed. It can also be printed for any
stored assay run by selecting 3.2.2.Specific Run or 3.2.3.Specific Run, select
Calibrators.
You can customize the laboratory report in 6.4.System Parameters as follows:
• Include calibration curve You can decide if you want the stored calibration
curve graph for a run to be printed or not. How-
ever, if calibrators were processed in the run the
calibration curve data will always be printed.
• Include calibrator data You can decide if you want the stored calibrator
data for a run to be printed or not. However, if
calibrators were processed in the run, the calibra-
tor data will always be printed.
• Unknown data order Unknown data can be listed by sample or by
method/test.
• Number of copies You can specify the number of laboratory report
copies to be automatically printed after each run.
You can select any number between 0 and 3.

Run sequence number

Run origin:
Date and time of the first entered LABORATORY REPORT Instrument The run was created
request
in the instrument
PC Remote The run was created
Date and time when the assay Run number: 18 on a PC using IDM
run process was started Run created: 090508 16:15
Process started: 090509 08:23
Date and time when the assay Process ended: 090509 11:19
run process was ended
Run origin: Instrument

Calibration code for this method

Each section begins with the ImmunoCAP and run
method name and contains all
the results of that method Specific IgE 0-100
Monthly calibration run:
Calibration code: AA
NO The calibration curve is
Monthly cal: NO
The sequence number used for included in the assay run
the calibration curve within the CALIBRATION INFORMATION YES The calibration curve is not
method included in the assay run
Calibration number: 3
Run date, time: 090508 08:23
Acceptance of the calibration
curve used: Calibration code: AA
Acceptance: OK Date and time when the Calibra-
OK Calibration curve Calculation type: Rodbard 5-parameters
tion curve was run
accepted
FLAGGED Calibration curve
flagged An error message is printed here
NOT OK Calibration curve if a Calibration Curve Error has
not accepted occured
Cont...

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Phadia 100 - User Manual Printouts

CURVE DATA
Expected dose and slope are only
ITEM--------VALUE printed if calculation type is other
than cut-off
ED-20 9.00
ED-50 27.0
ED-80 57.8
Slope 265

Response (RU)
100000

○
○
○

○
10000 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

○
○

○
Graphic image of the calibration

○
○

○
curve. If a point is rejected, it will

○
○

○
○
○

○
be printed as a cross

○
○

○
1000
This is only printed if calculation
○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

○
○

○
○
○

○
type is other than cut-off

○
○

○
○
○

○
100
○
○

○
○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
○
○

○
○
○

0.00 0.35 3.50 17.5 100

Concentration (kU/l)

CALIBRATOR DATA

NAME-----CONC--RESP--%CV--CALC--%CV 10
Identity of the calibrator point
Coefficient of variation of re-
sponses
Nominal concentration of calibra- CAL-0.00 0.001 20 0.00
tor point 20 0.00
mean 20 0.0 0.00 0.0 Calculated concentration of each
replicate and the mean value
CAL-0.35 0.35 184 0.35
Response of each replicate and 186 0.35
the mean value
mean 185 0.8 0.35 0.8
Coefficient of variation of calcu-
CAL-0.70 0.70 355 0.71 lated concentrations
343 0.69
mean 349 2.5 0.70 2.7

CAL-3.50 3.50 1641 3.55

1598 3.45
mean 1620 1.9 3.50 2.0

CAL-17.5 17.5 6903 17.2

7116 17.8
mean 7009 2.1 17.5 2.6

CAL-100 100 19630 90.9

Estimated and rejected response
values or warnings are written
here if an error has occured NAME------RESP----REMARK------------

CAL-100 20818 Rejected

Cont...

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Printouts Phadia 100 - User Manual

QUALITY CONTROLS Quality Controls:

OK Quality Control within
NAME----RESP--%CV--CONC--%CV-JUDGED limits
Identity of the QC sample
QC1 1465 3.60 OK HIGH Quality Control above
Response value for each QC repli- (t3) limit
cate LOW Quality Control below
QC2 2050 4.75 OK limit
If QC is NOT OK, the limits de- (d1) If no limits are defined, no judge-
fined for it are written here ment is made.

Calculated concentration
ImmunoCAP Total IgE
Calibration code: A3/A3
Monthly cal: YES
CALIBRATION INFORMATION
Calibration number: 1
Run date, time: 090509 12:34
Calibration code: A3/A3
Acceptance: OK
Calculation type: Rodbard 5-parameters
Coefficient of variation of calcu-
CURVE CONTROLS lated concentrations, if more than
one replicate
Identity of the curve control
NAME----RESP--%CV--CONC--%CV-JUDGED
Curve Controls:
Response and mean value of each
CC-1 160 10.1 OK
curve control replicate OK Curve Control within
CC-2 2381 200 OK inner limits
HIGH* Curve Control above
Coefficient of variation of re-
inner limits
sponses, if more than one repli- QUALITY CONTROLS LOW* Curve Control below
cate
inner limits
NAME----RESP--%CV--CONC--%CV-JUDGED HIGH Curve Control above
Calculated concentration and outer limits
mean value QC-1 3037 258 OK LOW Curve Control below
(a-IgE) outer limits

A message is printed here if a

Method requested for the patient SAMPLES Curve Control Error has occured
samples
-TEST---RESP---CONC---CLASS---QUOT-
Patient sample identity
S01 Depending on the method setup
Test requested for the patient ImmunoCAP Specific IgE (kUA/l) the test result will be presented
f1 239 0.53 1 in different ways

CV is too high! is printed here if fx1 208 Positive

the coefficient of variation is too LOW RU is printed instead of the
high for the specific test ImmunoCAP Total IgE (kU/l) response value if a LOW RU Error
a-IgE 94 4.40 has occured

ImmunoCAP Phadiatop (PAU/l)

phad 1455 3.58
S02
Software version number
Date and time of printout ImmunoCAP Specific IgE (kUA/l)
d3 97 <0.35 0

Instrument serial number t17 92 <0.35 0 Method version number

0354, 090509 10:12, 2.3, 032

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Phadia 100 - User Manual Printouts

At the end of the laboratory report Lot Information will be printed. All
registered bar-codes will be written next to all reagents and samples. If a bar-
code reader is not used there will be an empty line were the lot numbers can be
filled in by hand. This function can be disabled in 6.4.4.5.Print Lot information.
Below you find examples of printouts.

LOT INFORMATION
POS-MTH-TEST-SAMPLE-ImmunoCAP-CONJUGATE-CAL/CC/QC Lot number, ImmunoCAP
Position in ImmunoCAP Carousel [Lot Expiry] [Lot Expiry] [Lot Expiry]

1 sIgE a_IgECC-1 865T1 09/01! 9531C09/01! 700V1 09/01!

Method requested for the patient
2 sIgE a_IgECC-2 865T1 09/01! 9531C09/01! 700V1 09/01!
sample 3 tIgE a-IgECC-1 863T5 09/01! 943C209/01! 703V4 09/01!
Lot number, CAL/CC/QC
Name of the requested test ITEM Lot Expiry
Lot number, Conjugate
Development solution 939D1 09/01!
Patient sample identity Stop solution 940S1 The exclamation mark indicates
Washing Solution BGXWASH
that the reagent is expired
! MEANS THAT REAGENT IS EXPIRED

Example of Lot information for EliA test:

10
LOT INFORMATION
POS-MTH-TEST-SAMPLE-EliA Well-CONJUGATE-CAL/CC/QC Lot number, EliA Well
[Lot Expiry Code] [Lot Expiry] [Lot Expiry]
Position in ImmunoCAP Carousel
Lot Specific Code EliA
1 E1-G Gcal CC-1 BFN0309/10! 0000000 BFVA0 09/04!
Method requested for the patient 2 E1-G Gcal CC-1 BFN0309/10! 0000000 BFVA0 09/04!
sample 3 E1-G jo ANAPos 2S BFVA0 09/04!
4 E1-G dn ANAPos BFVA0 09/03 27 BFVA0 09/04! Lot number, CAL/CC/QC
Name of the requested test
ITEM Lot Expiry Lot number, Conjugate

Patient sample identity Development solution 939D1 10/10 The exclamation mark indicates
Stop solution 11/05
that the reagent is expired
Diluent (EliA Diluent)BFWA0 08/12!

! MEANS THAT REAGENT IS EXPIRED

If an error has occured information and recommended actions are printed at the
end of the Laboratory Report in order to help the operator to identify and
eliminate the error. For more information, see chapter 12, Error Handling.

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Printouts Phadia 100 - User Manual

Patient Report
The patient report lists the results for one patient. To get this printout select
3.1.1.All Samples in a Run or 3.1.2.Specific Sample on the instrument.
You can customize the patient report in 6.4.System Parameters as follows:
• Report comments You can write a text that will be printed on the top
of each patient report. The text can be up to three
lines of 40 characters each.

PATIENT REPORT
The customized text can be up to
three lines of 40 characters each
Laboratory XYZ
Address:...
Telephone:...

Patient sample identity

S01 The test result. Depending on the
method setup the results can be
Name of the method used for the
reported in different ways
requested tests ImmunoCAP Specific IgE 0-100--------
If more than one replicate is used,
f1 - Egg white only the mean value will be re-
Name of the requested tests Concentration: 2.53 kUA/l ported
Class: 2

fx1 - (f13 f17 f18 f20 f36)

Class: Positive

ImmunoCAP Total IgE-----------------

a-IgE - Total IgE

Concentration: 41.7 kU/l

ImmunoCAP Phadiatop ----------------

List of runs from where the pa-
phad - Phadiatop tient test result was included
Concentration: 3.58 PAU/l

Method version number

RESULTS FROM FOLLOWING RUNS:
Software version number 134 090507 15:13

Instrument serial number

0354, 090508 10:12, 2.3, 032
Date and time of printout

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Phadia 100 - User Manual Printouts

Calibrators
This printout lists the data of one stored calibration curve. If the calculation type
is other than cut-off, the calibration curve graph is also printed along with some
curve quality coefficients. To print this list select 4.3.1.Specific Calibrators.

CALIBRATORS
Acceptance of the calibration re-
Method name sult:
ImmunoCAP OK Calibration curve
The sequence number used for Specific IgE 0-100 accepted
the calibration curve within the FLAGGED Calibration curve
method Calibration number: 23 flagged
Run date, time: 090508 16:15 NOT OK Calibration curve
not accepted
Date and time of the run when Calibration code: 1P
the calibration curve was pro- Acceptance: OK
cessed Calculation type: Rodbard 5-parameters Calculation type defined by
method
Calibration code of the stored CURVE DATA
curve An error message is printed here
if a Calibration Curve Error has
ITEM--------VALUE occured

ED-20 9.00
ED-50 27.0 10
ED-80 57.8
Slope 265
Expected dose and slope are only
printed if calculation type is other
than cut-off Response (RU)
100000
○

○
○
○

10000 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
○
○

○
○
○

Graphic image of the calibration

○
○

curve. If a point is rejected, it will

○
○

○
○
○

1000 be printed as a cross.

○

○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
○

This is only printed if calculation

○
○

○
○
○

type is other than cut-off.

○
○

○
○
○

100
○
○

○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
○
○

○
○
○

0.00 0.35 3.50 17.5 100

Concentration (kU/l)

Cont...

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Printouts Phadia 100 - User Manual

CALIBRATOR DATA

NAME-----CONC--RESP--%CV--CALC--%CV

Identity of the calibrator point Coefficient of variation of re-

CAL-0.00 0.001 20 0.00
sponses
Nominal concentration of calibra- 20 0.00
tor point mean 20 0.0 0.00 0.0
Calculated concentration of each
CAL-0.35 0.35 184 0.35 replicate and the mean value
Response of each replicate and 186 0.35
the mean value mean 185 0.8 0.35 0.8 Coefficient of variation of calcu-
lated concentrations
CAL-0.70 0.70 355 0.71
343 0.69
mean 349 2.5 0.70 2.7

CAL-3.50 3.50 1641 3.55

1598 3.45
mean 1620 1.9 3.50 2.0

CAL-17.5 17.5 6903 17.2

7116 17.8
mean 7009 2.1 17.5 2.6

CAL-100 100 19630 90.9 Estimated and rejected response

values or warnings are written
here if an error has occured
NAME------RESP----REMARK------------
Software version number
CAL-100 20818 Rejected
Method version number
Instrument serial number
0354, 090508 17:12, 2.3, 032
Date and time of printout

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Phadia 100 - User Manual Printouts

Quality Control Log

This printout lists the data logged for one Quality Control point and a graph of
the logged data. To print the Quality Control log select 4.1.1.Quality control-
log on the instrument. The latest 100 logs are stored.

QUALITY CONTROL

Method name ImmunoCAP Identity of the QC

Specific IgE 0-100
Data listed here depends on how Test name of the QC
the limits are specified in the
Identity: Specific IgE Control t1
method Expected concentration as de-
Lot number: AVMAB
fined in the method
Expected conc: 0.70
Lot number for QC Expected s: 0.05
Limit s: 3.0 Expected standard deviation as
defined in the method
LOG GRAPH
Concentration (kUA/l) Maximum allowed standard de-
0.85 viation as defined in the method

•
•
• •
• •
•
0.70 • • •• •
Graphic presentation of the
•
• logged data for the selected

•
lotnumber. Each replicate is in-
cluded. Inactivated points are not
10
included. The format of the graph
0.55 depends on limits defined in the
• method.

090512 090514 090516 090518

LOG DATA
Date and time when each point
was logged Concentration of each logged
RUN DATE,TIME---LOT NO---CAL CODE--CONCENTRATION
point, in this example two repli-
Lot number of each logged point 090512 11:14 AVMAB 1F 0.72 0.65 cates
as stated on QC vial 090513 11:18 AVMAB 1T 0.66 0.68
090514 12:58 AVMAB 1T 0.61 0.69
090515 13:02 AVMAB 2T 0.70 0.69 Calibration code of used conju-
The asterisc indicates that a point gate for each logged point
090516 11:05 AVMAB 2T 0.73 0.69
has been inactivated and is not
plotted in the graph or included
090517 12:33 AVMAC 2T 0.72 0.75
in the mean, standard deviation
090518 12:53* AVMAC 2T <0.35 0.78
or % CV 090519 12:43 AVMAC 2T 0.77 0.74

Calculated mean concentration LOT NO------MEAN-------s-----%CV--- If a start date for the print is
and standard deviation for all QC AVMAB 0.68 0.03 5.1 defined, it is noted here
points with the same lot no AVMAC 0.75 0.02 2.8

Method version number

Instrument serial number
0354, 090520 10:12, 2.3, 032

Date and time of printout Software version number

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Printouts Phadia 100 - User Manual

Example of Quality Control for EliA test:

QUALITY CONTROL
Method name
Elia IgG
Identity of the QC

Identity: ANA Pos sy

Test name of the QC

LOG DATA

Lot number of each logged QC RUN DATE, TIME---LOT NO--CAL CODE--LIMIT-JUDGE Calibration code of used conju-
point gate for each logged point
090508 9:15 BFU7B A0 >1.00 OK
Date and time of the run 03460, 090508 19:03, 2.3, 032

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Phadia 100 - User Manual Printouts

Curve Control Log

This printout lists the data logged for one curve control and a graph of the logged
data. To print the Curve Control log select 4.1.2.Curve control-log on the
instrument. The latest 100 logs are stored.

CURVE CONTROL
Method name
ImmunoCAP
Specific IgE 0-100 Identity of the curve control

Identity: CC-1 Expected concentration as de-

Expected conc: 0.70 fined in the method
Expected s: 0.07
Limit s Inner: 2.2 Expected standard deviation
Limit s Outer: 3.5
Min/Max allowed standard de-
LOG GRAPH viation as defined in the method

Graphic presentation of the Concentration (kU/l)

logged data. Each replicate is in- 1.0
cluded. Inactivated points are
however not included
0.88 • •
• •
10
•
0.70
•
0.53 •
Inner limits Outer limits

0.40

•
090512 090514 090516 090518

LOG DATA
Concentration of each replicate
Date and time when each point RUN DATE,TIME--CAL CODE--CONCENTRATION in each logged point
was logged
090512 11:14 1F 0.72 Calibration code of used conju-
090513 11:18 1T 0.73 gate for each logged point
The asterisk indicates that a point
090514 12:58 1T 0.82
has been inactivated and is not
090515 13:02 2T 0.60
plotted in the graph or included
in the mean, standard deviation
090516 11:05 2T 0.81
or % CV 090517 12:33 2T 0.54
090518 12:53* 2T <0.35
090519 12:43 2T 0.77 Mean, standard deviation and
% CV for all active points in the
mean 0.71 log
Software version number s 0.05
%CV 14.8 If a start date for the print is
defined, it is noted here
Instrument serial number
0354, 090520 10:12, 2.3, 032
Date and time of printout Method version number

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Printouts Phadia 100 - User Manual

Run Summary
This printout lists processed runs stored in the instrument, with date and time
for assay run, methods, calibration code and mode. To print the Run Summary
select 3.2.1.Summary of Runs on the instrument.

RUN SUMMARY

-NO---DATE,TIME-----METHOD--CODE--MODE Methods included in the run

Sequence number of the run
134 090502 15:13 sIgE 34 Cal
Calibration code of used conju-
Date and time of the run tIgE 86 MC
gate for each method
ECP Cal

135 090503 13:54 sIgE 1F MC Mode of the run:

Software version number 136 090505 12:45 tIgE 86 MC Cal Calibrators included
ECP Cal MC Monthly Calibration
Concept. A monthly
Instrument serial number calibration run with
0354, 090508 10:12, 2.3, 032
curve controls
Date and time of printout

Method version number

Method Summary
This printout lists the names of the methods defined in the system. To print the
Method Summary select 5.4.1.Summary of Methods on the instrument.

METHOD SUMMARY

Name of each method NO--METHOD NAME--------------------

Abbreviated name of each method
01 ImmunoCAP Specific IgE 0-100(sIgE)
02 ImmunoCAP Total IgE (tIgE)
03 ImmunoCAP ECP (ECP)
04 ImmunoCAP Tryptase (Tryp)
05 ImmunoCAP Specific IgG (sIgG)
06 ImmunoCAP Specific IgA (sIgA)
07 EliA IgG (El-G)
08 EliA IgA (El-A)
09 EliA IgM (El-M)
Software version number 10 ImmunoCAP Specific IgG4 (IgG4)

Instrument serial number 0354, 090508 10:12, 2.3, 032

Method version number
Date and time of printout

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Phadia 100 - User Manual Printouts

Action List
The instrument will automatically print this list every time a Preparation Error
occurs. Action Lists can also be included in Laboratory Reports, FluoroC Run
Reports and Bland Reports if errors have occured. For more information about
Action Lists, see chapter 12, Error Handling.

Name of Preparation Error

LAMP VOLTAGE TOO LOW

Instructions on how to eliminate

the error
ACTION LIST
Check/replace fuse F904 and F906
Software version number
If error remains - contact Phadia representative
Instrument serial number
0354, 090508 10:12, 2.3, 032
Date and time of printout Method version number

Blank Report
The instrument will print this list every time an error has occured during the
Blank Check before an assay run is started. A Blank Report is also printed when
a Blank Check is run from 6.9.5.Run Blanks or when a Selftest, in which the
Blank Check is included, is performed from 6.9.6.Selftest. For more information 10
on how to run a Blank Check or a Selftest, see chapter 11, Maintenance.

Source:
Before assay The Blank run was
BLANK REPORT done before start of
run
Date and time of the Blank run Other The Blank run was
Run date, time: 090508 9:57 done separately
Remarks and an Action List are Source: Other
printed here if an error has
occured
Reagent Blank: 21.5 RU Measured values of Reagent
Rinse Blank: 12.6 RU Blank, Rinse Blank and Dark Blank
Software version number Dark Blank: 8.9 RU

0354, 090508 10:12, 3.2, 032

Instrument serial number
Method version number
Date and time of printout

If an error has occured, information and recommended actions are printed at the
end of the Blank Report in order to help the operator to identify and eliminate
the error. For more information, see chapter 12, Error Handling.

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Printouts Phadia 100 - User Manual

FluoroC Run Report

A FluoroC Run Report is printed when FluoroC is run from 6.9.3.FluoroC. For
more information on how to run FluoroC, see chapter 11, Maintenance.

FLUOROC RUN
Date and time of the FluoroC run FluoroC voltage and mean value

Measurement status: Run date, time: 090508 11:58 Coefficient of variation for
Measurement status: OK FluoroC
OK The measurement was Target value: DW (12500 RU)
accomplished
NOT OK The measurement could RESULTS-----------Value--Acceptance The rinse blank for the FluoroC
not be accomplished FluoroC voltage 1: 3923.0 mV run
FluoroC voltage 2: 3932.3 mV
FluoroC voltage 3: 3946.1 mV Judgement of acceptance can be
Target value stated on FluoroC FluoroC Mean voltage: 3933.8 mV OK or NOT OK
vial FluoroC %CV: 0.30 % OK
Rinse Blank voltage: 4.0 mV OK The final FluoroC mean voltage
An Action List is printed here if subtracted with Rinse blank
an error has occured Final FluoroC voltage: 3929.8 mV
Final FluoroC RU: 12280.5 RU
Deviation from target: -1.8 % OK The final FluoroC voltage con-
Software version number verted to RU
0354, 090508 12:12, 2.3, 032
Instrument serial number Deviation from target should not
exceed ±4%
Date and time of printout
Method version number

If an error has occured information and recommended actions are printed at the
end of the FluoroC Run Report in order to help the operator to identify and
eliminate the error. For more information, see chapter 12, Error Handling.

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Phadia 100 - User Manual Printouts

Method Setup
All the method data can be printed for each method defined in the system. To
print the method data select the option 5.4.2.Specific Method or 5.4.3.All
Methods on the instrument.
For USA; the methods ImmunoCAP ECP and ImmunoCAP Specific IgG4 are for
investigational use only. The performance characteristics of these products have
not been established.

Abbreviated name of the method

METHOD
Method name Monthly calibration:

ImmunoCAP Specific IgE 0-100 YES Monthly calibration is

Type of diluent possible
NO Monthly calibration is
Abbreviated name: sIgE not possible
Diluent in position G: Allow Monthly calibration: YES
Cal code on ImmunoCAP/Well: NO
YES The diluent bottle should Calibration code:
be placed in position G in
the Sample Carousel Diluent: Diluent YES Calibration code on
NO The instrument will posi- Diluent in pos. G: NO ImmunoCAP/EliA Well
tion the diluent bottle in NO No calibration code on
one of positions 2-48 in
REAGENTS ImmunoCAP/EliA Well
the Sample Carousel de-
pending on the setup of NAME--VOLUME (μl)-INC (min)-IDENTITY
the run Incubation time for each compo-
Sample
Conj
40
50
30
24 sIgE
nent 10
Dev sol 50 9
Stop sol 600 Identity stated on vial
Amount needed for each compo-
nent per determination CURVE CONTROLS
Status can be set to ACTIVE, IN-
Status: ACTIVE ACTIVE or MANUAL
Identity: CC-1
Test name: a_IgE Identity of the curve control
Replicate: 1
Concentration: 0.70 Number of replicates for the curve
Expected s: 0.084 control
Limit s Inner: 2.2
Limit s Outer: 3.5
Log start date: Concentration of the curve con-
trol
Status: ACTIVE
Identity: CC-2 Expected standard deviation and
Test name: a_IgE inner and outer limits
Replicate: 1
Concentration: 17.5
Expected s: 1.75
Limit s Inner: 2.2
Limit s Outer: 3.5
Log start date:

Cont...

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Printouts Phadia 100 - User Manual

Number of days before a flagged

calibration curve turns NOT OK. 0
means that the function is inacti- CALIBRATORS Number of days until the calibra-
vated tion curve is too old
Test name: a_IgE
Age until warning: 28
Number of days it is possible to Age until pre-warning: Number of days before the in-
21 strument will request you to run
change a calibration curve la- Max. flagged time: 0
belled NOT OK to OK. 0 means Max. reactivate time: a new calibration curve
0
that the function is inactivated Max. bad replicates: 3
Maximum number of bad repli-
NAME----------CONC-------REPL.------ cates in each calibration curve
Identity of the calibrator point assay
CAL-0.35 0.35 2
Nominal concentration of calibra-
CAL-0.70 0.70 2
tor point
CAL-3.50 3.50 2
CAL-17.5 17.5 2 Number of replicates
CAL-50.0 50.0 2
CAL-100 100 2

BLANK
Subtraction of reagent blank:
Subtract: YES YES The reagent blank is
Parameters for graphic presenta- subtracted
PRESENTATION NO The reagent blank is
tion of the calibration curve
not subtracted
X-axis text: Concentration
X-axis scale: LOGARITHMIC
X-axis unit: kU/l
Y-axis text: Response
Y-axis scale: LOGARITHMIC
Y-axis unit: RU

CALCULATION

Calculation type:Rodbard 5-parameters

Information regarding methods Normal Weight: Predicted
of calculation of the calibration
Robust Weight: None
curve
Predicted Variance A: 1.847208
Predicted Variance B: 0.000574
Min. Coeff. of Correlation: 0.00000

Zero-point switch (0=off): 0

Lowest concentration: 0.00
Selection of cut-off point. In this
CUT-OFF case 0.35, which is the first cali-
brator point
Cut-off point: 1
Text below reference: Negative Text on Laboratory Report and
Text above reference: Positive Patient Report for values above
and below the cut-off point
Parameters for presentation of CALIBRATION CURVE
values outside the calibration
curve range Concentration unit A: kUA/l
Quantitative Below: <0.35
Qantitative Above: >100
Text below lowest: 0
LIMIT----------TEXT ABOVE LIMIT-----

Concentration limits for sample 0.35 1

classes 0.70 2 Sample classes
3.50 3
17.5 4
50.0 5
100 6

Cont...

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Phadia 100 - User Manual Printouts

Alternative scoring method for

samples
CUT-OFF 2

Text below lowest: 0

Limits for classes of sample re- LIMIT----------TEXT ABOVE LIMIT-----
sponse, calculated as percentage
of the lowest calibrator point
65.0 0/1
90.0 1
150.0 2
360.0 3
960.0 4
4000.0 5 Dilution method:
25000.0 6 INSTRUMENT Instrument
dilution
Default parameters for samples UNKNOWNS PREDILUTED No instrument
dilution
Dilution method: PREDILUTED
Dilution factor: 1
%CV limit resp: 16.5 Limit for message CV too high!

TESTS
Choice of presentation for test
List of all tests included in the NAME--FULL NAME-------REPL--REPORT-- results
method
c1 Penicilloyl G 1 Conc Class
c2 Penicilloyl V 1 Conc Class
Abbreviated name of test c206 ACTH 1 Conc Class
c207 Protamine 1 Conc Class
d1 D. pteronyssinus 1 Conc Class
d2 D. farinae 1 Conc Class
e1 Cat epithelium and dander1 Conc Class
e2 Dog epithelium 1 Conc Class
e205 Horse serum proteins 1 Conc Class
e206 Rabbit serum proteins 1 Conc Class
e211 Rabbit, urine proteins 1 Conc Class
e3 Horse dander 1 Conc Class
10
e5 Dog dander 1 Conc Class
e84 Hamster epithelium 1 Conc Class
f13 Peanut 1 Conc Class
f14 Soya bean 1 Conc Class
f17 Hazel nut 1 Conc Class
f2 Milk 1 Conc Class
f24 Shrimp 1 Conc Class
f245 Egg 1 Conc Class
f256 Walnut 1 Conc Class
f26 Pork 1 Conc Class
f3 Fish (cod) 1 Conc Class
f342 Olive 1 Conc Class
f4 Wheat 1 Conc Class
f79 Gluten 1 Conc Class
f96 Avocado 1 Conc Class
g6 Timothy 1 Conc Class
i206 Cockroach, American 1 Conc Class
m3 Aspergillus fumigatus 1 Conc Class
m6 Alternaria alternata 1 Conc Class
t19 Acacia 1 Conc Class
t203 Horse chestnut 1 Conc Class
t3 Common silver birch 1 Conc Class
t9 Olive 1 Conc Class
w1 Common ragweed 1 Conc Class
w206 Camomile 1 Conc Class
w21 Wall pellitory (P.judaica)1 Conc Class
w8 Dandelion 1 Conc Class

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Phadia 100 - User Manual Maintenance

Chapter 11 - Maintenance
This chapter describes the maintenance of
Phadia 100

Maintenance
Daily Maintenance
2
3
2
Daily Rinse 3
Emptying of the Waste Bottle 4
Emptying of ImmunoCAP Waste Container 4
Cleaning of the Processing Chamber 4

Weekly Maintenance 6
Monthly Maintenance 7
Monthly Maintenance Procedure 7
Lubrication of O-rings 9
Cleaning of the Sample Carousel 10
Outside Cleaning 10
Restart the Instrument 10

5
Semiannual Maintenance 11
Replace Washing and Rinse Tubings 11
Replace Drainage Filter 12

Unscheduled Maintenance 13
Actions Before Shutdown and Startup 13

6
Selftest 13
Blank Run 15
11
FluoroC Run 17
Load Printer Paper 19
Replace Fuses 20
Replace broken Bottle Holders on the Sample Carousel 21
Replace broken Tube Holders on the Sample Carousel 22
6.9.4.System Rinse 24

Log for Maintenance 25

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Maintenance Phadia 100 - User Manual

Maintenance

Maintenance has to be done regularly in order to keep the instrument in good

condition and to secure the instrument performance.
Negligence of maintenance leads to Processing Errors as well as Assay Result
Errors. The best way to avoid errors is to perform maintenance regularly
according to this chapter. To help the laboratory to check that maintenance is
performed, a maintenance log is provided at the end of this chapter.
Maintenance has to be done with different time intervals:
• Daily
• Weekly
• Monthly
• Semiannual
• Unscheduled
If maintenance is not performed regularly, the instrument will display a message
requesting the appropriate maintenance. You may also be prompted to perform
maintenance on Action Lists. Daily maintenance has to be done each day an
assay run has been performed, otherwise it is not possible to use the instrument.
Please read the information in this chapter thoroughly and make sure to
perform the necessary maintenance regularly.

WARNING! Phadia 100 pipettes human body

fluids, which might be infected. When servicing
and maintaining Phadia 100, take precautions to
avoid direct contact with parts that have been in
contact with samples. Wear protective gloves!

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Phadia 100 - User Manual Maintenance

Daily Maintenance

The following points are included in the daily maintenance:

2
• Daily Rinse
• Emptying of the Waste Bottle
• Emptying of ImmunoCAP Waste Container
• Cleaning of the Processing Chamber

Daily Rinse
Daily rinse is done in order to prevent from blockage, growth and carry over.
Perform it at the end of each day you have used Phadia 100.
Disconnect the Washing Solution Bottle by using the quick release. Replace the
Washing Solution Bottle with a beaker filled with approximately 300 ml
purified water. Unscrew the cap from the Washing Solution Bottle and connect
it to the quick release. Put the wash tubing in the beaker with purified water.

WARNING! Washing Solution may cause

sensitization by skin contact. Wear protective
gloves!
5
Check that the Waste Bottle is empty before you start the process.

1. In Install/Service mode
press the number 9 key.
6.Install/Service
6
11

1.Login/Logout?

2. Press the yes key. 6.Install/Service

9.Maintenance?

3. Press the yes key. 6.9.Maintenance

1.Daily Maintenance?

4. Press the enter key to 6.9.1.Daily Maintenance

confirm this step. The process PRESS ENTER TO START PROCESS
takes approximately six min-
utes.

When the maintenance is completed, empty the Waste Bottle and the beaker.
NOTE! Do not unscrew the cap from the bottles if the tubings are still
connected. This can lead to insufficient distribution of Washing and Rinse
Solution due to twisted tubings inside the instrument. Never put the wash tubing
into the Rinse Solution Bottle.

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Maintenance Phadia 100 - User Manual

Emptying of the Waste Bottle

Empty the Waste Bottle to prevent owerflow and contamination.

WARNING! Phadia 100 Waste Bottle collects

waste liquids containing human body fluids,
which might be infected. When emptying and
cleaning the Waste Bottle, take precautions to
avoid direct contact with the liquids.
Wear protective gloves!
For disposal follow local procedures for biohaz-
ard material!

Emptying of ImmunoCAP Waste

Container
The ImmunoCAP Waste Container is located in the Processing Chamber, to the
left.
Press lid open and open the Processing Lid.
Pull out the container, empty it and put it back again.
NOTE! The ImmunoCAP Waste Container has to be emptied after every assay
run because it can only hold ImmunoCAP/EliA Wells from one full run. If you

WARNING! Waste bottle, ImmunoCAP waste

container and process chamber may be
contaminated by potentially infectious,
biohazard material - take appropriate actions.
Wear protective gloves!

do not empty it, it may lead to loose ImmunoCAP/EliA Wells in the Processing
Chamber.

Cleaning of the Processing Chamber

Cleaning of the Processing Chamber includes cleaning of the Elution Wells Disc,
ImmunoCAP Holder Disc and Processing Lid.
NOTE! The ImmunoCAP Holder Disc is fragile and should be handled as glass.
Press lid open and open the Processing Lid.
Take out the ImmunoCAP Holder Disc and Elution Wells Disc and rinse them
in purified water. Dry them carefully, preferably with compressed air. If not

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Phadia 100 - User Manual Maintenance

available, leave to dry upside down, preferably not on paper (paper dust can be
fluoroscent).
Wipe off the Processing Chamber with a tissue. If a lot of water remains in the
Processing Chamber, highten the instrument by unscrewing the feet a few
millimeters on the printer side. It is important to keep the Processing Chamber
clean and dry.
Wipe off the underside of the Processing Lid with purified water in order to secure
the ImmunoCAP/ELiA Well transfer.
Install the Elution Wells Disc and ImmunoCAP Holder Disc. Make sure not to
exchange the Elution Wells Disc between instruments.
2
NOTE! Before closing the Processing Lid, check that the wash rake is well above
the ImmunoCAP Carousel, otherwise it might break something inside. The wash
rake can be moved manually.

WARNING! Phadia 100 processing chamber is

exposed to human body fluids, which might be
infected. When servicing and maintaining Phadia
100, take precautions to avoid direct contact
with parts that have been in contact with
samples. Wear protective gloves!

5
6
11

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Maintenance Phadia 100 - User Manual

Weekly Maintenance

The weekly maintenance is done in order to clean the Washing Solution, Rinse
Solution and Waste Bottles and the beaker used in daily maintenance to prevent
blockage, growth and carry over.
In general, it is the same procedure as the daily maintenance, but with one
important additional item: Disconnect the Washing Solution, Rinse Solution and
Waste Bottle by using the quick release. Empty and rinse the bottles and the
beaker three times with purified water.
NOTE! Do not unscrew the cap from the bottles if the tubings are still connected.
This can cause problems with insufficient distribution of Washing and Rinse
Solutions due to twisted tubings inside the instrument.
Fill the Washing Solution and Rinse Solution Bottles with approximately 300 ml
purified water and connect them to Phadia 100. Also connect the Waste Bottle
to the instrument.

1. In Maintenance mode 6.9.Maintenance

press the number 7 key. 1.Daily Maintenance?

2. Press the yes key. 6.9.Maintenance

7.Weekly Maintenance?

3. Press the enter key to 6.9.7.Weekly Maintenance

confirm this step. The rinsing PRESS ENTER TO START PROCESS
procedure takes approxi-
mately six minutes.

4. When the weekly mainte- EMPTY AND CLEAN WASH AND RINSE BOTTLES
nance procedure is finished, PRESS ENTER TO CONFIRM THE ACTION
empty and clean the Washing
Solution and Rinse Solution
Bottles. Press the enter key to
confirm this step.

WARNING! Washing Solution may cause

sensitization by skin contact. Wear protective
gloves!

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Phadia 100 - User Manual Maintenance

Monthly Maintenance

The following points are included in the monthly maintenance:

2
• Monthly Maintenance Procedure
• Lubrication of o-rings
• Cleaning of the Sample Carousel
• Outside cleaning
• Deletion of instrument log files
To perform Monthly Maintenance you need ImmunoCAP Maintenance Solution
Kit (10-9476-01). For preparing the Maintenance Solution add one ampule (23
ml) of Maintenance Concentrate to 1500 ml purified water. Mix gently in a glass
beaker. Please read and follow the warnings and instructions carefully. Monthly
Maintenance is also used as a corrective action, see Action List.

Monthly Maintenance Procedure

A cleaning of Phadia 100 has to be done once a month. When handling

5
Maintenance Solution protective gloves should be used.

1. In Maintenance mode 6.9.Maintenance

press the number 2 key. 1.Daily Maintenance?

2. Press the yes key.

3. Press lid open and open

6.9.Maintenance
2.Monthly Maintenance?

6.9.2.Monthly Maintenance
6
11

the Processing Lid. Place four LOAD 4 CheckCAP IN POS 1-4

CheckCAP in position 1 to 4 in
the ImmunoCAP Holder Disc
and close the Processing Lid.
Press enter to confirm this step.

NOTE! ImmunoCAP Holder Disc is fragile and should be handled as glass.

4. Fill a clean and empty 6.9.2.Monthly Maintenance

conjugate vial (diameter 22 LOAD MAINT SOLUTION IN POS.G
mm) with 5 ml Maintenance
Solution and place the vial in
the Sample Carousel in posi-
tion G. Press the enter key to
confirm this step.

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Maintenance Phadia 100 - User Manual

5. Add 1 ml of antifoam in 6.9.2.Monthly Maintenance

the Waste Bottle. Press the LOAD WASTE WITH ANTIFOAM
enter key to confirm this step.

6. Fill the empty Rinse Solu- 6.9.2.Monthly Maintenance

tion, Washing Solution and LOAD RINSE/WASH/WASTE WITH MAINT SOL
Waste Bottles, each with 200
ml Maintenance Solution.
Shake the bottles gently and
connect them to the instrument.
Also fill the beaker used in daily
maintenance with Maintenance
Solution. Confirm this step by
pressing the enter key.

7. Press the enter key to start 6.9.2.Monthly Maintenance

the process. The procedure PRESS ENTER TO START PROCESS
takes approximately 30 min-
utes.

8. When the process is fin- MONTHLY MAINTENANCE WASH

ished rinse the Washing Solu- EMPTY AND CLEAN WASH/RINSE
tion and Rinse Solution Bottles
and their bottle caps and the
beaker carefully five times with
tap water and finally one time
with purified water. Press the
enter key to confirm this step.

9. Press the enter key. Fill MONTHLY MAINTENANCE WASH

the Rinse Solution and Wash- LOAD RINSE/WASH WITH PURIFIED WATER
ing Solution Bottles with
350 ml of purified water each.

10. Press the enter key. The MONTHLY MAINTENANCE WASH

Monthly Maintenance Wash PRESS ENTER TO START PROCESS
takes approximately 30 min-
utes.

11. When the Monthly Main- MONTHLY MAINTENANCE WASH

tenance Wash is finished press REMOVE ImmunoCAP HOLDER/ELUT.WELL DISK
lid open and open the Process-
ing Lid.

Take out the ImmunoCAP Holder Disc and discard the four CheckCAP. Take
out the Elution Wells Disc and the Drainage Filter and place them in Mainte-
nance Solution. Leave them in the Maintenance Solution for 30 minutes. Press
enter to confirm this step.
NOTE! The ImmunoCAP Holder Disc is fragile and should be handled as glass.

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Phadia 100 - User Manual Maintenance

12. Disconnect and empty the MONTHLY MAINTENANCE WASH

Washing Solution, Rinse Solu- CLEAN PROCESS CHAMBER/EMPTY ALL BOTTLES
tion and Waste Bottle. Press
enter to confirm this step.

NOTE! Do not unscrew the caps from the bottles if the tubings are still
connected. This can cause problems with insufficient distribution of Washing
and Rinse Solution due to twisted tubings inside the instrument.
After the 30 minutes incubation time in the Maintenance Solution, rinse the
ImmunoCAP Holder Disc and Elution Wells Disc thoroughly with purified
water. Dry them carefully, preferably with compressed air. If not available,
2
leave to dry upside down, preferably not on paper (paper dust can be fluoroscent).
Rinse the Drainage Filter with purified water.
Wipe off the Processing Chamber and the Processing Lid with a tissue moistened
with Maintenance Solution.
NOTE! See semiannual maintenance for information how to remove the
drainage filter.
Reinstall the Drainage Filter, the Elution Wells Disc and the ImmunoCAP
Holder Disc in the Processing Chamber.
NOTE! Before closing the processing lid, check that the wash rake is well above
the ImmunoCAP Carousel, otherwise it might break something inside. The
wash rake can be moved manually.

Lubrication of O-rings 5
The lubrication of the o-rings is important in order to secure the connection and
make it smooth.

13. Disconnect the tubings

from the Washing Solution,
Rinse Solution and Waste
MONTHLY MAINTENANCE WASH
LUBRICATE O-RINGS ON BOTTLES CONNECTIONS
6
11

Bottles. Lubrication
Lubricate the O-rings on the Points
bottle connections of the rinse
and waste bottle tubings, and
the connection on the Washing
Solution Bottle with vacuum
grease (12-3505-12). Use only
a small amount of vacuum
grease to avoid the lubricant
from entering the bottles. Press
enter to confirm this step.

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Maintenance Phadia 100 - User Manual

Cleaning of the
Sample Carousel
Remove the Sample Carousel. Place it in
prepared Maintenance Solution. Leave it in
the Maintenance Solution for 30 minutes.
Rinse the Sample Carousel thoroughly with Optical
tap water and dry it with a paper tissue. Sensors
Wipe off the compartment with a tissue,
moistened with prepared Maintenance Solu-
tion.
NOTE! Be careful not to damage the optical
sensors located in the compartment.

Outside Cleaning
Wipe off the instrument with a tissue, moistened with prepared Maintenance
Solution. Do not forget to wipe off the area where the bottles are placed.

Restart the Instrument

Restart the instrument to maintain a good performance of the internal harddisk.
For Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the instruc-
tions displayed to safely shut down the instrument. Switch Phadia 100 off, wait
10 seconds and switch the instrument on again.

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Phadia 100 - User Manual Maintenance

Semiannual Maintenance

The following points are included in the semiannual maintenance:

2
• Replacement of the Wash and Rinse tubings
• Replacement of the Drainage Filter.

1. In Maintenance mode 6.9.Maintenance

press the number 8 key. 1.Daily Maintenance?

2. Press the yes key. 6.9.Maintenance

8.Semiannual Maintenance?

3. When the filters are re- 6.9.8.Semiannual Maintenance

placed press the enter key to REPLACE BOTTLE FILTERS/DRAINAGE FILTER
confirm this step.

Replace Wash and Rinse Tubings

In each of the Washing Solution and Rinse Solution Bottles there are tubings with
bottle filters at the end that prevent particles from entering valves. It is advisable
to replace these tubings and filters once every six months.
5
Disconnect the Washing Solution and the Rinse Solution Bottles by using the

6
quick release. Unscrew the caps from the bottles.

11
WARNING! Washing Solution may cause
sensitization by skin contact. Wear protective
gloves!

Unscrew the nut under each cap and pull the tubing from the nipple.
Push a new tubing on firmly and screw the nut back in position.
Screw the caps back on the bottles before you connect them to the instrument.

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Maintenance Phadia 100 - User Manual

Replace Drainage
Filter
At the bottom of the Processing Chamber
there is a drainage filter (12-3500-75) that
prevents particles from entering valves. It
is advisable to replace it every six months.
Press lid open and open the Processing
Lid.
Pull out the drainage filter from the Pro-
cessing Chamber using a pair of forceps
or pliers. Replace it with a new drainage
filter. In case waste does not disappear
from the processing chamber the drain-
age filter can be changed more often.

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Phadia 100 - User Manual Maintenance

Unscheduled Maintenance

The following points are included in the unscheduled maintenance:

2
• Actions before Shutdown and Startup
• Selftest
• Blank Run
• FluoroC Run
• Loading of Printer Paper
• Changing of Fuses
• System Rinse

Actions Before Shutdown and Startup

For Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the instruc-
tions displayed to safely shut down the instrument.
Before switching Phadia 100 off for longer than a month a daily maintenance has

5
to be processed twice. The first rinse has to run with purified water, followed by
a run without any liquid at all.
Wipe off any remaining liquid from the Processing Chamber.
Before starting up again, perform a monthly maintenance and a selftest.

Selftest 6
11

The selftest checks various functions of the instrument.

WARNING! Washing Solution may cause

sensitization by skin contact. Wear protective
gloves!

To run a selftest you need Development Solution and Stop Solution. Make sure
that the Washing Solution and Rinse Solution Bottles are filled and connected to
the instrument.

1. In Prepare Run mode se- Phadia 100 Ver.3.0 07:55:06

lect the number 6 key. 1.Prepare Run?

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Maintenance Phadia 100 - User Manual

2. Press the yes key. Phadia 100 Ver.3.0 07:55:06

6.Install/Service?

3. In Install/Service mode
select the number 9 key. 6.Install/Service
1.Login/Logout?

4. Press the yes key.

6.Install/Service
9.Maintenance?
5. In Maintenance mode se- 6.9.Maintenance
lect the number 6 key. 1.Daily Maintenance?

6. Press the yes key. 6.9.Maintenance

6.Run Selftest?

7. Press the enter key to start

6.9.6.Run Selftest
the selftest. PRESS ENTER TO START A BLANK CHECK

8. Load the Development 6.9.6.Run Selftest

Solution vial in position E. Press LOAD DEV SOL IN POS E
the enter key to confirm this
step.

9. Load the Stop Solution 6.9.6.Run Selftest

vial in the given position. Press LOAD STOP SOL IN POS H
the enter key to confirm this
step.

10. Press the enter key to start

6.9.6.Run Selftest
the process. PRESS ENTER TO START PROCESS

After the selftest is finished the instrument will automatically print a Blank
Report where you can see the result of the selftest. If you have received a section
on the printout with remarks you have a Blank Error. An action list will then be
printed at the end of the report, with instructions on how to eliminate the error.
For more information on how to eliminate the error, see chapter 12, Error
Handling.

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Phadia 100 - User Manual Maintenance

Example of a Blank Report:

BLANK REPORT

Run date, time:

Source:

Reagent Blank:
090513 11:13
Other

14.2 RU
2
Rinse Blank: 12.3 RU
Dark Blank: 7.9 RU

00847,090513 11:13, 2.3, 032

Blank Run
The Blank Run checks the cuvette and reagents. The Blank Run is included in
6.9.6.Run Selftest.
To perform a Blank Run you need Development Solution and Stop Solution.
5
Make sure that the Washing solution and Rinse Solution Bottles are filled and
connected to the instrument.

WARNING! Washing Solution may cause

sensitization by skin contact. Wear protective
6
11

gloves!

1. In Prepare Run mode press Phadia 100 Ver.3.0 07:55:06

the number 6 key. 1.Prepare Run?

2. Press the yes key. Phadia 100 Ver.3.0 07:55:06

6.Install/Service?

3. In the Install/Service 6.Install/Service

mode press the number 9 key. 1.Login/Logout?

4. Press the yes key. 6.Install/Service

9.Maintenance?

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Maintenance Phadia 100 - User Manual

5. In the Maintenance mode 6.9.Maintenance

select the number 5 key. 1.Daily Maintenance?

6. Press the yes key.

6.9.Maintenance
5.Run Blanks?
7. Press the enter key to start
6.9.5.Run Blanks
the Blank Run.
PRESS ENTER TO START A BLANK CHECK

8. Load the Development

6.9.5.Run Blanks
Solution vial in position E.
LOAD DEV SOL IN POS E
Confirm this step by pressing
the enter key.

9. Load the Stop Solution

6.9.5.Run Blanks
vial in position H. Confirm this
LOAD STOP SOL IN POS H
step by pressing the enter key.

10. Press the enter key to start 6.9.5.Run Blanks

the process. PRESS ENTER TO START PROCESS

After the Blank Run is finished the instrument will automatically print a Blank
Report where you can see the result of the Blank Run. If you have received a
section on the printout with remarks you have a Blank Error. An action list will
then be printed at the end of the report, with instructions on how to eliminate
the error. For more information on how to eliminate the error, see chapter 12,
Error Handling.
Example of a Blank Report:

BLANK REPORT

Run date, time: 090507 9:57

Source: Other

Reagent Blank: 21.5 RU

Rinse Blank: 12.6 RU
Dark Blank: 8.9 RU

0354, 090507 10:12, 2.3, 032

A blank report will automatically be printed

after 6.9.6.Run Selftest and 6.9.5.Run Blanks or
if an error has occured during the Load and
Start.

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Phadia 100 - User Manual Maintenance

FluoroC Run
The FluoroC run is used for service and trouble shooting, and checks the
performance of the fluorometer.
To run FluoroC you need FluoroC Solution and Stop Solution. The FluoroC vial
must be at room temperature before the run. Use only new FluoroC vials in each
run.
Make sure that the Washing Solution and Rinse Solution Bottles are filled and
connected to the instrument. 2
WARNING! Washing Solution may cause
sensitization by skin contact. Wear protective
gloves!

The FluoroC run takes approximately seven minutes regardless of the warm-up
time.

1. In the Prepare Run mode Phadia 100 Ver.3.0 07:55:06

select the number 6 key. 1.Prepare Run?

5
2. Press the yes key. Phadia 100 Ver.3.0 07:55:06
6.Install/Service?

3. In the Install/Service 6.Install/Service

mode select the number 9 key. 1.Login/Logout?

4. Press the yes key.

5. In the Maintenance mode

6.Install/Service
9.Maintenance? 6
11

6.9.Maintenance
select the number 3 key. 1.Daily Maintenance?

6. Press the yes key. 6.9.Maintenance

3.FluoroC?

7. Press the yes key. 6.9.3.FluoroC

1.FluoroC Run?

8. Check the target value of 6.9.3.1.FluoroC Run Target:DW_

the FluoroC and load the LOAD 1890 ul FLUOROC IN POS F
FluoroC vial in the given posi-
tion.

FluoroC target
value (on the vial)

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Maintenance Phadia 100 - User Manual

If the displayed target value is to be used, press the enter key.

If a new target value is to be entered, type the value and press the enter key.
Confirm the new target value by typing it again and pressing the enter key.

9. Load the Stop Solution 6.9.3.1.FluoroC Run

vial in the given position. Con- LOAD 180 ul STOP SOL IN POS H
firm this step by pressing the
enter key.

10. To start the process press 6.9.3.1.FluoroC Run

the enter key. PRESS ENTER TO START PROCESS

After the FluoroC run is finished the instrument will automatically print a
FluoroC Run Report. On the report you can see the result of the FluoroC run.
If you have received a NOT OK on the printout for FluoroC %CV, Rinse Blank
voltage, or Deviation from target, you have a FluoroC error. Follow the short
instructions on the action list on the printout to eliminate the error.
For further information on how to eliminate the error, see chapter 12, Error
Handling.
Example of a FluoroC Run Report:

FLUOROC RUN

Run date, time: 090513 11:53

Measurement status: OK
Target value: DW (12500 RU)

RESULTS------------Value--Acceptance
FluoroC voltage 1: 3923.0 mV
FluoroC voltage 2: 3932.3 mV
FluoroC voltage 3: 3946.1 mV
FluoroC Mean voltage: 3933.8 mV
FluoroC %CV: 0.30 % OK
Rinse Blank voltage: 4.0 mV OK

Final FluoroC voltage: 3929.8 mV

Final FluoroC RU: 12280.5 RU
Deviation from target: -1.8 % OK

0354, 090513 12:12, 2.3, 032

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Phadia 100 - User Manual Maintenance

Load Printer Paper

Turn the instrument on. Open the printer lid and take out the old paper roll.

2
View from above with
Printer lid open

1. Take new Printer Paper

(ArtNo.12-3501-05). Cut the
end of the new paper roll to
form an arrow. Fit the roll pin
in the new paper roll.
View from the right hand
side of the Printer

2. Unroll ~10 cm of paper

from the roll. Insert the end of
the paper into the paper inlet of
the paper holder. Place the pa-
Instrument
body 5
per roll in position.

6
Paper roll
Paper holder
3. When the paper is visible 11
in the paper collection area of
the paper holder, push it for-
ward.

4. When you can see the tip

of the paper coming out of the
printer, do not pull it out by
hand. Use instead the paper
feed button which you find on
the right side of the keyboard. If
the paper is pulled out by hand,
the printer is easily damaged.

Extra paper rolls (ArtNo. 12-3501-05) are included in the accessories box.
NOTE! Make sure that the paper roll is inserted in the right direction.

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Maintenance Phadia 100 - User Manual

Replace Fuses
Extra primary and secondary fuses are included in the accessory box.
NOTE! Replace only with fuses of specified type and rating.

Primary Fuses

1. Disconnect the mains

power cord.

2. Open the fuse/voltage se-

lector cover using a screwdriver.
Insert the screwdriver at the
top center and apply pressure.

3. Take out the fuse holders

from the instrument and re-
move the old fuses.

4. Place new fuses in the fuse

holders and install them in both
the left- and right-hand posi-
tion in the instrument.

5. Close the cover.

6. Connect the mains power

cord.

NOTE! Phadia 100 must only be connected to a

grounded power outlet (protective ground).

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Phadia 100 - User Manual Maintenance

Secondary Fuses

1. Disconnect the mains

power cord.

2. Use a screwdriver to open

2
the fuse holder. Put the screw-
driver in the vertical slot in the
fuse holder and turn it counter-
clockwise.

3. Take out the fuse holder

from the instrument and re-
move the old fuse.

4. Place a new fuse in the

fuse holder and install it in the
instrument.

5. Connect the mains power

cord.

NOTE! Phadia 100 must only be connected to a

grounded power outlet (protective ground).
5
Replace broken Bottle Holders on the
6
11

Sample Carousel

1. Push the Bottle holder

back towards the edge of the
Sample Carousel. Lift the front
of the Bottle holder and turn
the holder sideways. Pull the
Bottle holder up. Fig. 1.

Fig.1
2. Place a new Bottle holder
in the position where the bro-
ken one was placed.

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Maintenance Phadia 100 - User Manual

3. Press it downwards until

it is in position. Be careful not
to break the holder at the front
of the Bottle holder (marked by
being encircled in Fig. 2).

Fig.2

Replace broken Tube Holders on the

Sample Carousel

1. Unscrew the center screw.

Fig. 3.

Fig.3

2. Lift the upper part of the

Sample Carousel. Fig. 4.

Fig.4

3. Remove the broken Tube

holder and replace it with a
new one. Fig. 5.

Fig.5

4. Remove the Tube holder

guide from inside the Sample
Carousel bowl. Fig. 6.

Fig.6

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Phadia 100 - User Manual Maintenance

5. Place the upper part of the

Sample Carousel upside down
on a table.
Fig. 7.

2
Fig.7

6. Put the Tube holder guide

that you removed from inside
the Sample Carousel bowl, on
top of the upper part of the
Sample Carousel. Fig. 8.

Fig.8

7. While holding the two

parts together, turn them up-
side again. Fig.9

8. Insert the two parts to-

Fig.9
5
gether inside the Sample Car-
ousel bowl. Fig.10

6
11

Fig.10

9. Insert the center screw

again. Fig. 11.

Fig.11

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Maintenance Phadia 100 - User Manual

6.9.4.System Rinse
A completed assay run ends with a System Rinse automatically. If the process
have been aborted by a processing error, you have to perform 6.9.4.System
Rinse.
Make sure that there is enough Rinse and space in the Waste Bottle (it normally
should if it was enough at the start of the assay run).

1. In Maintenance mode 6.9.Maintenance

press the number 4 key. 1.Daily Maintenance?

2. Press the yes key. 6.9.Maintenance

4.System Rinse?

3. Press the enter key to con- 6.9.4.System Rinse

firm this step. PRESS ENTER TO START PROCESS

When the System Rinse is done finish off as after a completed assay run.

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Phadia 100 - User Manual Maintenance

Log for Maintenance

Please, copy this form and make a note every time you perform maintenance.

Date Action Signature

5
6
11

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Maintenance Phadia 100 - User Manual

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Phadia 100 - User Manual Error Handling

Chapter 12 - Error Handling

This chapter describes different error cases
and how they are eliminated

Introduction 2
Start Up Errors and Start Up Warnings 3
Start Up Errors 3
Start Up Warnings 3

Operator Interaction Messages 4

Preparation Errors 6
Processing Errors 14
Assay Result Errors 37
Calibration Curve Errors 37
Curve Control Errors 41
Quality Control Errors 47
Blank Errors 49
LOW RU Errors 51
FluoroC Errors 53

Explanation of Actions 56
Mechanical and Electrical Malfunction 62
No Power On 62
No Display Text 62
Communication Errors 62
No Print Out 63
Bad Print Out 63
Leakage 63
12

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Error Handling Phadia 100 - User Manual

Introduction

This chapter describes the different errors you might receive while operating
Phadia 100. During operation Phadia 100 continuously checks that the system
is working properly. If an abnormality is found, it results in an error or warning.
Many of these errors can be avoided if maintenance of
Phadia 100 is done carefully according to chapter 11, Maintenance, and reagents
are handled according to chapter 3, Reagent and Sample Handling.
There are six types of errors:
• Start up errors and warnings
• Operator interaction messages
• Preparation errors
• Processing errors
• Assay result errors
• Mechanical and electrical malfunction
Depending on the error type the operator will be provided with different kinds
of information regarding the error and how to eliminate it. In some cases the
instrument will stop the process until the error is eliminated. In other cases the
assay run will be aborted and the instrument will not produce any results.
Sometimes the instrument will produce results for the assay run, but it is up to
the operator to decide if the results are to be used.
Before contacting your local Phadia representative, please make a note of the
complete error message including the error code. Also note the instrument serial
number and software version number.

WARNING! Phadia 100 pipettes human body

fluids, which might be infected. When servicing
and maintaining Phadia 100, take precautions to
avoid direct contact with parts that have been in
contact with samples. Wear protective gloves!

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Phadia 100 - User Manual Error Handling

Start Up Errors and Start Up Warnings

When the system is started, a number of checks are made to ensure that
everything is running correctly. If an abnormality is found, it results in a Start
up error or a Start up warning.

Start Up Errors
Errors are normally issued for serious malfunctions when there is no meaning of
continuing the start up. If an error is displayed, the system halts and the operator
is instructed to call for service. Start by switching
Phadia 100 off, wait 10 seconds and switch the instrument on again.
If the error returns make a note of the error code and contact your local Phadia
representative.
Example of a start up error:
STARTUP ERROR #1201
Startup was aborted. Call service...

Start Up Warnings
If the malfunction is of a less serious type, a warning is issued. The operator is
instructed to note the warning and then press any key. Example of a start up
warning:
STARTUP WARNING #2301
Note warning, then press Any key...

When a key has been pressed, the startup continues. 12

If the warning returns contact your local Phadia representative.

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Error Handling Phadia 100 - User Manual

Operator Interaction Messages

These types of messages can be shown when operating Phadia 100 using the
keyboard. Common sources of problems are disk access, that a specific file on
the harddisk cannot be read or written or that there is a problem accessing the
USB memory, external USB hard drive or diskette.
Example of an operator interaction message:

3.4.Import Data
E010: MEDIA NOT INSERTED, ABORT?

There are three types of operator interaction messages:

Information type error Pressing any key will continue.
Continue/abort error Press yes or no to answer the question.
Fatal error This is indicated by FE instead of E by the error
number. The system stops at this type of error.

E009: MEDIA WRITE-PROTECTED, ABORT?

If you receive this error remove the write protection or change USB memory,
external USB hard drive or diskette. Press no if you want to continue or yes if
you want to abort.

E010: MEDIA NOT INSERTED, ABORT?

If you receive this error insert a a USB memory, an external USB hard drive or
a diskette. Press no if you want to continue or yes if you want to abort.

E011: MEDIA ERROR, ABORT?

If you receive this error the USB memory, the external USB hard drive or the
diskette is not formatted or it is damaged. Format the media or change it. Press
no if you want to continue or yes if you want to abort.

E012: MEDIA FULL, ABORT?

If you receive this error the USB memory, the external USB hard drive or the
diskette is full. Delete old files on the media or change it. Press no if you want
to continue or yes if you want to abort.

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Phadia 100 - User Manual Error Handling

FILE NOT FOUND

ACCESS DENIED
FILE INVALID
CANNOT CREATE FILE
NO METHODS DEFINED
FUNCTION NOT IMPLEMENTED YET
These errors can occur with error codes between 001-002 and 101-611. For
Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the instructions
displayed to safely shut down the instrument. Switch Phadia 100 off, wait 10
seconds and switch it on again.
If the error returns, please make a note of the error code, and contact your local
Phadia representative.

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Error Handling Phadia 100 - User Manual

Preparation Errors

These errors may occur during the preparation of an assay run. An Action List
with short instructions will be printed every time a message is displayed.
Example of a preparation error:

1.3.Load and Start

LAMP VOLTAGE TOO LOW

The following Action List will be generated:

The Preparation Error is printed

here
LAMP VOLTAGE TOO LOW
Action List with instructions on
how to eliminate the error
ACTION LIST
Check/replace fuse F904 and F906

If error remain - contact Phadia representative

0354, 090507 10:12, 2.3, 032

Follow the instructions and perform the necessary steps to eliminate the error.
If needed you will find more detailed information in this chapter. When the error
is eliminated you will be able to continue assay preparation.

SAMPLE CAROUSEL COVER IS NOT PRESENT

What can cause the problem:
The black device on the left side of the Sample Carousel has not been pushed in.
Indicating that that Sample Carousel Cover is not present/in position.
Corrective actions:
Put the Sample Carousel Cover in position. Will minimize evaporation from
samples and reagents and also to protect them from contamination.

PROCESSING LID IS NOT CLOSED

What can cause the problem:
The sensor in the Process Chamber gets information that the Processing Lid is
not closed. If the Processing Lid is not closed several functions in the instrument
will not work.
Corrective actions:
Close the Processing Lid properly and make sure nothing is obstructing the lid.

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Phadia 100 - User Manual Error Handling

PROCESSING LID IS NOT LOCKED

What can cause the problem:
Processing Lid is not locked.
Corrective actions:
Make sure that the Processing Lid is locked properly.

ImmunoCAP CAROUSEL IS NOT PRESENT

Place the ImmunoCAP Carousel in the Processing Chamber.

LAMP VOLTAGE TOO LOW

What can cause the problem:
The Fluorometer Lamp Voltage is too low.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Check fuse F904 and F906, and replace them if necessary. For additional
information see Chapter 11, Replace fuses.
If the error remains contact your local Phadia representative.

LAMP VOLTAGE TOO HIGH

What can cause the problem:
The Fluorometer Lamp Voltage is too high.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Check fuse F905, and replace it if necessary. For additional information see
Chapter 11, Replace fuses.
If the error remains contact your local Phadia representative.
12
PRESSURE TOO LOW (nnnn hPa)
The system pressure is too low. The system pressure has to be at a certain level
(above 1200 hPa) in order for the system to produce reliable results. nnnn is the
actual pressure in hPa.
If the error remains contact your local Phadia representative.

ImmunoCAP NOT DISPENSED #n

What can cause the problem:
The instrument cannot detect an ImmunoCAP in the specified position.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
If the error remains contact your local Phadia representative.

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Error Handling Phadia 100 - User Manual

EliA WELL NOT DISPENSED #n

What can cause the problem:
The instrument cannot detect an EliA Well in the specified position.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
If the error remains contact your local Phadia representative.

CHECK ImmunoCAP DISPENSE #n

What can cause the problem:
The ImmunoCAP Carousel cannot move.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Check for any ImmunoCAP/Well blocking the movement. Check the processing
chamber for loose ImmunoCAP/EliA Wells, look under the Elution Wells Disc
check also under the Wash Rake.
If the error remains contact your local Phadia representative.

CHECK EliA WELL DISPENSE #n

CONTROLLER BOARD TEMPERATURE TOO HIGH

What can cause the problem:
The temperature around the Controller Board in the upper part of the instrument
is too high. If you receive this error the ambient temperature might be too high
or the cooling fan might have stopped.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Check if the fan in the top box is running. Check by holding the hand on the back
of the instrument upper left side. If no air stream the fan has stopped.
If the error remains contact your local Phadia representative.

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Phadia 100 - User Manual Error Handling

TEMPERATURE SENSORS DIFFER

What can cause the problem:
There is a difference in temperature between the sensors in the upper and lower
parts of the instrument.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Check if the fan in the top box is running. Check by holding the hand on the back
of the instrument upper left side. If no air stream the fan has stopped.
If the error remains contact your local Phadia representative.

CHECK CAPS ON VIALS

There is a vial cap left on one or more of the vials in the Sample Carousel.
Make sure that all vial caps are removed. This message is inactivated by default.
If the error remains contact your local Phadia representative.

WASH/RINSE CHECK NOT OK

What can cause the problem:
The distribution of Washing Solution is insufficiant. Washing Solution might not
have been loaded. This error will also occur if either Rinse Solution or Washing
Solution have been loaded in both bottles. The error can also occur when the
Washing Solution has not been mixed thoroughly.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Make sure that the tubing from the Washing and Rinse Solution bottles are not
twisted and that the tubings are properly connected to the bottles. To avoid
twisted tubes, connect tubings after Washing and Rinse Solution bottles have
been recapped. Check that the tubings to the bottle filters are connected
properly. For additional information see Chapter 11, Semiannual Maintenance.
12
Check that Rinse Solution is loaded in Rinse bottle and Washing Solution is
loaded in Washing Solution Bottle. Shake both Washing and Rinse Solution
bottle, the bottle with Washing Solution will foam.
Always make sure to mix the Washing Solution according to the Directions for
Use for Washing Solution.
If the error remains contact your local Phadia representative.

WASH/RINSE HAVE BEEN MIXED

What can cause the problem:
Washing Solution and Rinse Solution bottles or connections have been mixed or
Rinse Solution could be contaminated.

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Error Handling Phadia 100 - User Manual

Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Ensure that Washing Solution and Rinse Solution are properly prepared. The
Washing Solution Concentration is of big importance for several tests. Always
prepare according to Directions for Use. Always use purified water when
preparing Washing Solution and Rinse Solution.
Check that Rinse Solution is loaded in Rinse bottle and Washing Solution is
loaded in Washing Solution Bottle. Shake both Washing and Rinse Solution
bottle, the bottle with Washing Solution will foam.
If the error remains contact your local Phadia representative.

INTERNAL ERROR
There is an internal system error. It is not possible to start the assay run.
Contact your local Phadia representative.

DAILY MAINTENANCE NOT PERFORMED

The daily maintenance has not been performed within 24 hours after the last
completed run. It is important to perform daily maintenance in order to keep the
instrument in good condition.
Please perform daily maintenance every day, see chapter 11, Maintenance.

WEEKLY MAINTENANCE NOT PERFORMED

The weekly maintenance is required. It is important to perform weekly
maintenance in order to keep the instrument in good condition.
Please perform weekly maintenance once a week, see chapter 11, Maintenance.

MONTHLY MAINTENANCE NOT PERFORMED

The monthly maintenance is required. It is important to perform monthly
maintenance in order to keep the instrument in good condition.
Please perform monthly maintenance once a month, see chapter 11, Mainte-
nance.

BLANK CHECK ERROR

Blank Errors might be detected when the instrument performs a Blank Check. The
Blank Check is used to test the reagent blank, which is subtracted from the results
obtained in the assay run. The Blank Check also tests the quality of the Rinse Solution
and the function of the cuvette and fluorometer. When Blank Check Error is
displayed a blank report will automatically be printed.

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Phadia 100 - User Manual Error Handling

Example of a blank report:

BLANK REPORT

Run date, time: 090507 10:00

Source: Before Assay

Reagent Blank: 13.5 RU

Rinse Blank: 11.7 RU
Dark Blank: 9.4 RU

REMARKS The Blank Check errors are printed

here
THE DIFFERENCE BETWEEN REAGENT BLANK
AND RINSE BLANK IS TOO LOW

SEE ACTION LIST FOR CORRECTIVE ACTIONS

Action List with instructions on

how to eliminate the error
ACTION LIST
The Cuvette is probably broken
Run Selftest, menu 6.9.6.

If Blank Error remain - Contact Phadia representative

The blank check errors are specified underneath Remarks on the Blank Report.
At the end of the Blank Report you find the action list with instructions on how
12
to eliminate the errors.
0354, 090507 10:12, 2.3, 032
Four different blank check errors can occur:

REAGENT BLANK IS TOO HIGH

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Error Handling Phadia 100 - User Manual

NORMAL VALUES
For ImmunoCAP between 10 - 20 RU and for EliA between 15 - 35 RU.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Clean and dry (not with Paper tissue) Elution Wells Disc, see Chapter 11,
Cleaning of the process chamber.
Avoid mixing up the Development Solution vial cap and the Conjugate vial cap.
Small amounts of Conjugate coming in contact with the Development Solution
affects the background signal of the Development Solution. Residues of
conjugate on the vial cap is enough to affect the Development Solution function
next time it will be used.
Perform Monthly Maintenance as corrective action before next run in order to
clean the instrument. Monthly Maintenance should be done even if the regular
Monthly Maintenance has been done recently. Something has happened during
the run and the instrument needs to be cleaned, like after Rinse Solution and
Washing Solution distribution problems, lack of maintenance or vacuum
problems. After going trough all other actions on the list first and thereby
eliminate the error it could be that Monthly Maintenance can be skipped this
time.
If the error remains contact your local Phadia representative.

THE DIFFERENCE BETWEEN REAGENT BLANK

AND RINSE BLANK IS TOO LOW
The difference between the Reagent Blank and Rinse Blank is less than 1.875 RU
which is too low.
What can cause the problem:
Broken cuvette. Rinse Solution or Washing Solution in both bottles. Rinse
Solution that is contaminated.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Check visually if the Cuvette is broken. Is the Cuvette broken, clean up the
Processing Chamber. Make sure there is no glass in the process chamber, check
Elution Wells Disc, lift up and look underneath also. Look for misplaced
ImmunoCAP/EliA Well on Elution Wells Disc, under Elution Wells Disc and
under Wash Rake. If ImmunoCAP/EliA Well is found, that is probably the
cause.
If ImmunoCAP not dispensed and Check ImmunoCAP Dispense have occurred
prior to this error situation, that can be an indication of future problems when
there has been ImmunoCAP Dispense errors. Always check that no misplaced
ImmunoCAP/EliA Well is in the Processing Chamber after this error message.
Always empty the ImmunoCAP Waste Container after every run.

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Phadia 100 - User Manual Error Handling

RINSE BLANK IS TOO HIGH

If the Rinse blank is >31.25 RU this error will occur.
What can cause the problem:
This error might be caused by contamination of the Rinse Solution or that the
Rinse Bottle has been filled with the wrong solution. Dirty cuvette or Elution
Wells Disc can also cause the error.
NORMAL VALUES
5 - 20 RU
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Perform Monthly Maintenance as corrective action before next run in order to
clean the instrument. Monthly Maintenance should be done even if the regular
Monthly Maintenance has been done recently. Something has happened during
the run and the instrument needs to be cleaned, like after Rinse Solution and
Washing Solution distribution problems, lack of maintenance or vacuum
problems. After going through all other actions on the list first and thereby
eliminate the error it could be that Monthly Maintenance can be skipped this
time.
If the error remains contact your local Phadia representative.

DARK BLANK IS TOO HIGH

If the Dark blank is >15.625 RU this error will occur.
NORMAL VALUES
12
5 - 10 RU
What can cause the problem:
This error might be caused by too much light in the Processing Chamber.
Corrective actions:
Make sure the instrument is not placed in direct sunlight.
If the error remains contact your local Phadia representative.

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Error Handling Phadia 100 - User Manual

Processing Errors

Processing Errors may occur during processing of the assay run. The amount of
Processing Errors and the affected positions in the ImmunoCAP Carousel are printed
underneath PROCESS ERRORS on the Laboratory Report. You find a list of the
errors underneath ERROR LIST. The Error List is followed by an Action List with
short instructions on how to eliminate the errors.
You may receive more than one Processing Error on the Error List. The short
instructions will then be combined into one Action List.

PROCESS ERRORS
The number of errors in the speci-
The positions in the ImmunoCAP POS-METHOD-TEST--SAMPLE ID----#ERROR fied position is printed here
Carousel which are affected by
the errors are printed here 01 sIgE a-IgE CAL-0.35 1
15 sIgE t3 32418 2

ERROR LIST The Processing Errors are printed

here
1.00001 FATAL #30.00 090507 11:57:21 Position:15 CANNOT FIND SAMPLE
2.00001 FATAL #39.00 090507 11:57:23 Position:15 SAMPLE TUBE EMPTY
3.00001 WARN #25.81 090507 12:04:21 Position: 1 BENT PIPETTE

Action List with instructions on

how to eliminate the errors ACTION LIST
See User Manual, Index: Error case descriptions
Ensure sufficient volume in reagent vials, See User Manual, Index: Dead volumes
If a position is specified: it refers to a position in the ImmunoCAP Carousel
Check/place the Sample Carousel Cover in correct position
The Pipette or the Pipette Arm might have been touched during run
Check that tubes have proper shape, See User Manual, Index: Tube shapes
Vial/tube missing. Check according to Distribution List
Check that the Processing Lid is properly closed
Check if ImmunoCAP/Well has been in incorrect position in ImmunoCAP Carousel

If error message #30 remain - Contact Phadia representative

If error message #39 remain - Contact Phadia representative
Rerun the results that have not been reported

There might have been air bubbles in reagent/sample vials/tubes

If no reason for error message #25 found - Contact Phadia representative

0354, 090507 17:53, 2.3, 032

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Phadia 100 - User Manual Error Handling

Example of an Error List and an Action List printed at the end of a Laboratory Report:
A question mark (?) is printed on the Laboratory Report indicating that a
Processing Error has occured for the calibrator, curve control, Quality Control
or sample.

SAMPLES
-TEST---RESP---CONC---CLASS---QUOT--

32418
ImmunoCAP Specific IgE (kUA/l)
t3 1591? 7.09 3
The question mark indicates
which result the processing error SEE ACTION LIST FOR CORRECTIVE ACTIONS
has affected

Example of a question mark printed on the Laboratory Report:

If a Processing Error has occured, a Distribution List is automatically printed
after the Laboratory Report. By comparing the information underneath PROC-
ESS ERRORS with the information on the Distribution List you can identify the
affected position in the Sample Carousel and the component involved in the
error. With this information it might be easier to identify and eliminate the cause
of the error. Note that one sample might be found in several positions in the
ImmunoCAP Carousel.

DISTRIBUTION LIST

Run number: 1
12
Run created: 090507 14:29
Process started: 090507 15:23
Process ended: 090507 17:51
Run origin: Instrument

SAMPLE CAROUSEL
A sIgG Conjugate
E Development solution
G IgA/IgG diluent Diluent
H Stop solution
01 sIgG CAL-0.02 Cal
02 sIgG CAL-0.04 Cal
03 sIgG CAL-0.1 Cal
04 sIgG CAL-0.3 Cal
05 sIgG CAL-1.0 Cal
06 sIgG CAL-2.0 Cal
Cont...

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Error Handling Phadia 100 - User Manual

09 32418 Sample
10 33279 Sample The position in the Sample Car-
11 34703 Sample ousel in which the component
12 34703 Empty Instr 10 involved in the error is placed.

The position in the ImmunoCAP

Carousel which is affected by the
ImmunoCAP CAROUSEL
error. 01 sIgG AGcal <- 01 CAL-0.02
02 sIgG AGcal <- 01 CAL-0.02
Type of component involved in
03 sIgG AGcal <- 02 CAL-0.04 the error.
04 sIgG AGcal <- 02 CAL-0.04
05 sIgG AGcal <- 03 CAL-0.1
06 sIgG AGcal <- 03 CAL-0.1
07 sIgG AGcal <- 04 CAL-0.3
08 sIgG AGcal <- 04 CAL-0.3
09 sIgG AGcal <- 05 CAL-1.0
10 sIgG AGcal <- 05 CAL-1.0
11 sIgG AGcal <- 06 CAL-2.0
12 sIgG AGcal <- 06 CAL-2.0

0354, 090507 17:53, 2.3, 032

Example of a Distribution List:

Follow the instructions and perform the necessary steps. Do not empty the
instrument before you perform the actions listed on the Action List since this
might complicate identification of the cause of the error. Make sure that you
have used the correct reagents and that they are placed in the right positions in
the Sample Carousel. A more detailed information on each Processing Error is
provided in this chapter.
Processing Errors will often lead to Assay Result Errors. Eliminating the
Processing Errors can then automatically lead to elimination of the Assay Result
Errors.
The Processing Errors can be labelled FATAL, WARN or ERROR.
If a Processing Error is fatal the instrument will stop the processing of
ImmunoCAP, or EliA Wells, and in some cases abort the assay run. The
instrument will not produce any results for that specific test.
If a Processing Error is just a warning the instrument will produce results for the
assay run. However if the error is generated by Curve Controls or Calibrators,
their limits will take over and advise the operator. Please note that warnings can
cause Assay Result Errors.
If a Processing Error is labelled error the instrument will not produce any results
for that specific test.
Before contacting your local Phadia representative, always make a note of the
complete error message including the error code. Also note the instrument serial
number and software version number. Use 6.11.3.Create Instrument Event Log
to create an instrument event log on a diskette. This log file can then be sent to
your local Phadia representative to make troubleshooting easier.

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Phadia 100 - User Manual Error Handling

General explanation of abbreviations

XX: Indicate sub-code number
Stepper Motor table:
XX.x1 Pipette Z Motor
XX.x2 Pipette R Motor
XX.x3 Pipette Pump Motor
XX.x4 Fluorometer Motor
XX.x5 ImmunoCAP Carousel Motor
XX.x6 Sample Carousel Motor
XX.x7 Wash Rake Motor
XX.x8 ImmunoCAP Transfer Motor

R: Pipette motor, right to LEFT MOVEMENT

PipetteR-position table:
XX.1x At Serum position
XX.2x At Conjugate position
XX.3x At Development position
XX.4x At FluoroC position
XX.5x At Stop Solution position
XX.6x At Diluent position
XX.7x At Reagent Dispense position
XX.8x At Stop Solution Dispense position
XX.9x At Pipette Wash position

Assay Process Step table

12
XX.01 Pre Wash
XX.02 Incubation #1
XX.03 Serum Wash
XX.04 Incubation #2
XX.05 Conjugate Wash
XX.06 Incubation #3
XX.07 Serum Pipetting
XX.08 Conjugate Pipetting
XX.09 Development Solution Pipetting
XX.10 Stop Solution Pipetting
XX.11 Fluorometer Reading

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Error Handling Phadia 100 - User Manual

nn: Indicates ImmunoCAP/EliA Well position

time: Tells you Number of seconds the incubation has been exceeded with
Z: Pipette motor, up and down movement
Sometimes Z [nnn] is displayed together with the error message. [nnn] indicates
the position of pipette. This information is for service purpose only.

FATAL #01.00 CODE FF EXECUTED

What can cause the problem:
This error is caused by an external disturbance or it has occurred an error in the
electronics. The assay run is aborted.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Empty instrument manually and run Monthly Maintenance. Unload Sample
Carousel, open Processing lid and lift up ImmunoCAP holder disc. Throw away
ImmunoCAP or EliA Wells. Check that no ImmunoCAP or EliA Wells are left
in or under the Elution Wells Disc. Check also under Wash Rake. After
emptying the instrument, perform a complete Monthly Maintenance, see
Chapter 11.
Load old run and rerun Samples. Check that sample and reagent volumes are
enough for the rerun. Look at consumption list and include dead volume for the
sample tubes. Rerun the results that have not been reported. Load the assay run
again by first using 1.5.Load Old Run.
If the error remains contact your local Phadia representative.

FATAL #02.00 SPURIOUS HARDWARE INTERRUPT

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Phadia 100 - User Manual Error Handling

FATAL #03.00 SPURIOUS NMI INTERRUPT

FATAL #04.00 CONTROLLER HALTED

What can cause the problem:
This error is caused by an external disturbance or it has occurred an error in the
electronics.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Empty instrument manually and run Monthly Maintenance. Unload Sample
Carousel, open Processing lid and lift up ImmunoCAP holder disc. Throw away
ImmunoCAP or EliA Wells. Check that no ImmunoCAP or EliA Wells are left
in or under the Elution Wells Disc. Check also under Wash Rake. After
emptying the instrument, perform a complete Monthly Maintenance, see
Chapter 11.
12
Load old run and rerun Samples. Check that sample and reagent volumes are
enough for the rerun. Look at consumption list and include dead volume for the
sample tubes. Rerun the results that have not been reported. Load the assay run
again by first using 1.5.Load Old Run.
If the error remains contact your local Phadia representative.

WARN #05.00 POWER TEMPORARY LOST

A short power down (<10 msec) has occurred. The processing has not been
disturbed.
What can cause the problem:
If this error occurs frequently it is an indication of a bad mains supply, or that
something is wrong in the power supply unit.

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Error Handling Phadia 100 - User Manual

Corrective actions:
A solution to this problem can be to install an uninterruptable power supply unit
(UPS).

FATAL #10.XX-12.XX INC EXCEEDED WITH [time] S

What can cause the problem:
This message occurs when one of the incubations has been too long. There are
three incubations and the message is printed as:
FATAL #10.00 Position: [nn] INC1 EXCEEDED WITH [time] S
FATAL #11.00 Position: [nn] INC2 EXCEEDED WITH [time] S
FATAL #12.00 Position: [nn] INC3 EXCEEDED WITH [time] S
If these errors occur, it indicates timing problems in the level detection or other
processing steps, like bent pipette arm. It is common that these errors occur
together with other errors.
Corrective actions:
If these errors occur without any other errors at the same time or if they return
contact your local Phadia representative.

FATAL #13.XX Position: [nn] PROCEDURE

What can cause the problem:
This error occurs if the program cannot be executed. It could happen if there is
something wrong with the diskette drive or the hard disk, if there is something
wrong with the files, communication between the PC and Controller Board, or
memory problems on the Controller Board. The assay run is aborted.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Load old run and rerun Samples. Check that sample and reagent volumes are
enough for the rerun. Look at consumption list and include dead volume for the
sample tubes. Rerun the results that have not been reported. Load the assay run
again by first using 1.5.Load Old Run.
If the error remains contact your local Phadia representative.

FATAL #14.XX NOT INITIALIZED

What can cause the problem:
One of the motors is not initialized and the assay run could be aborted.
Contact your local Phadia representative.

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Phadia 100 - User Manual Error Handling

FATAL #15.XX NOT CALIBRATED

What can cause the problem:
One of the motors is not calibrated.
Contact your local Phadia representative.

#16.XX CAN'T FIND FLAG

One of the motors seems not to work due to an electronical or mechanical
malfunction.
There might be some obstruction or locking jam that prevents the movement to
be completed.

FATAL #16.01 PIPETTE Z MOTOR CAN'T FIND FLAG

What can cause the problem:
The Pipette Z motor does not seem to work. Make sure that nothing is blocking
the up and down movement of the pipette arm.
Corrective actions:
For Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the instruc-
tions displayed to safely shut down the instrument. Switch Phadia 100 off, wait
10 seconds and switch on again.
Follow instructions in Action List in order to identify or eliminate the errors.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

FATAL #16.02 PIPETTE R MOTOR CAN'T FIND FLAG

What can cause the problem:
12
The Pipette R motor does not seem to work. Make sure that nothing is blocking
the left and right movement of the pipette arm.
Corrective actions:
For Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the instruc-
tions displayed to safely shut down the instrument. Switch Phadia 100 off, wait
10 seconds and switch on again.
Follow instructions in Action List in order to identify or eliminate the errors.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

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Error Handling Phadia 100 - User Manual

FATAL #16.03 PIPETTE PUMP MOTOR CAN'T FIND FLAG

What can cause the problem:
The Pipette Pump motor does not seem to work.
Corrective actions:
Contact your local Phadia representative.

FATAL #16.04 FLUOROMETER MOTOR CAN'T FIND FLAG

What can cause the problem:
The Fluorometer motor does not seem to work.
Corrective actions:
Contact your local Phadia representative.

FATAL #16.05 CAP CAROUSEL MOTOR CAN'T FIND FLAG

What can cause the problem:
The ImmunoCAP Carousel motor does not seem to work. Make sure that nothing
is blocking the movement of the ImmunoCAP Carousel.
Corrective actions:
For Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the instruc-
tions displayed to safely shut down the instrument. Switch Phadia 100 off, wait
10 seconds and switch on again.
Follow instructions in Action List in order to identify or eliminate the errors.
Check/Remove if the movement of the ImmunoCAP Carousel has been ob-
structed. Check the processing chamber for loose ImmunoCAP/EliA Wells, look
under the Elution Wells Disc, check also under the Wash Rake. Clean the
processing chamber. If problem persist call service.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

FATAL #16.06 SAMPLE CAROUSEL MOTOR CAN'T FIND FLAG

What can cause the problem:
The Sample Carousel motor does not seem to work. Make sure that the Sample
Carousel is placed in its right position and that nothing is blocking the
movement.
Corrective actions:
For Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the instruc-
tions displayed to safely shut down the instrument. Switch Phadia 100 off, wait
10 seconds and switch on again.

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Phadia 100 - User Manual Error Handling

Follow instructions in Action List in order to identify or eliminate the errors.

Check/remove if the movement of the Sample Carousel has been obstructed.
Make sure that nothing is blocking the movement by rotating the Sample
Carousel. Switch the Phadia 100 off, wait 10 seconds and switch on again. Clean
under the sample carousel if needed.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

FATAL #16.07 WASH RAKE MOTOR CAN'T FIND FLAG

What can cause the problem:
The Wash Rake motor does not seem to work. Make sure that nothing is blocking
the up and down movement of the Wash Rake.
Corrective actions:
For Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the instruc-
tions displayed to safely shut down the instrument. Switch Phadia 100 off, wait
10 seconds and switch on again.
Follow instructions in Action List in order to identify or eliminate the errors.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

FATAL #16.08 CAP TRANSFER MOTOR CAN'T FIND FLAG

The ImmunoCAP Transfer motor does not seem to work.
Contact your local Phadia representative.
12
#17.XX OUT OF RANGE
What can cause the problem:
One of the motors is not correctly calibrated.

#17.01-17.08
Sub code see Stepper Motor table
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
If the error remains contact your local Phadia representative.

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Error Handling Phadia 100 - User Manual

#17.09
Contact your local Phadia representative.

FATAL #18.00 Position: [nn] ABORTED

The operator has aborted the processing.

#24.XX CAN'T POS FLAG

One of the motors does not seem to work due to an electronical or mechanical
malfunction. There might be some obstruction or locking jam that prevents the
movement to be completed.

FATAL #24.01 PIPETTE Z MOTOR CAN'T POS FLAG

What can cause the problem:
The Pipette Z motor does not seem to work.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

FATAL #24.02 PIPETTE R MOTOR CAN'T POS FLAG

What can cause the problem:
The Pipette R motor does not seem to work.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

FATAL #24.03 PIPETTE PUMP MOTOR CAN'T POS FLAG

The Pipette Pump motor does not seem to work.
Contact your local Phadia representative.

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Phadia 100 - User Manual Error Handling

FATAL #24.04 FLUOROMETER MOTOR CAN'T POS FLAG

The Fluorometer motor does not seem to work.
Contact your local Phadia representative.

FATAL #24.05 CAP CAROUSEL MOTOR CAN'T POS FLAG

What can cause the problem:
The ImmunoCAP Carousel motor does not seem to work. Make sure that nothing
is blocking the movement of the ImmunoCAP Carousel.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Check/Remove if the movement of the ImmunoCAP Carousel has been ob-
structed. Check the processing chamber for loose ImmunoCAP/EliA Wells, look
under the Elution Wells Disc, check also under the Wash Rake. Clean the
processing chamber. If problem persist call service.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

FATAL #24.06 SAMPLE CAROUSEL MOTOR CAN'T POS FLAG

What can cause the problem:
The Sample Carousel motor does not seem to work. Make sure that the Sample
Carousel is placed in its correct position and that nothing is blocking the
movement.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Check/remove if the movement of the Sample Carousel has been obstructed.
Make sure that nothing is blocking the movement by rotating the Sample 12
Carousel. For Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the
instructions displayed to safely shut down the instrument. Switch the Phadia 100
off, wait 10 seconds and switch on again. Clean under the sample carousel if
needed.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

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Error Handling Phadia 100 - User Manual

FATAL #24.07 WASH RAKE MOTOR CAN'T POS FLAG

What can cause the problem:
The Wash Rake motor does not seem to work. Make sure that nothing is blocking
the up and down movement of the Wash Rake.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

FATAL #24.08 CAP TRANSFER MOTOR CAN'T POS FLAG

The ImmunoCAP Transfer motor does not seem to work.
Contact your local Phadia representative.

#25.XX Position: [nn] BENT PIPETTE

The pipette has touched something. Check that the pipette arm can move freely.
Several different sub-codes exist for Error #25.
Depending on the sub-code different actions have to be taken:
CAP Carousel:
25.7x (x=1,2,5) Reagent dispense position
25.8x (x=1,2,5) Stop Solution dispense position
For x see Stepper Motor table.
Caused by:
ImmunoCAP/EliA Well in wrong position.
Lack of maintenance.
Wash Rake Z level too low.
Sample Carousel
25.1x (x=1,2,6) Serum position
25.2x (x=1,2,6) Conjugate Position
25.3x (x=1,2,6) Development position
25.4x (x=1,2,6) FluoroC position
25.5x (x=1,2,6) Stop Solution position
25.6x (x=1,2,6) Diluent Position
For x see Stepper Motor table.

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Phadia 100 - User Manual Error Handling

Caused by:
Wrong positioning of tube or reagent vial. Touching the pipette arm.
Sample Carousel Cover in wrong position.
Pipette Wash Position
25.9x (x=1,2)
For x see Stepper Motor table.
Caused by:
Something blocking the Wash Position.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
Contact your local Phadia representative.

#27.XX Position: [nn] ALREADY IN

FLUID
Sub code see Pipette R- position table.
What can cause the problem:
The level detector detects fluid when it is not
supposed to. A droplet of fluid may be stuck
between the electrodes and the pipette aspi-
rates air. There might be fluid around the
Pipette tubing connection.
Corrective actions: Removal and refitting of Pipette Arm
cover.
Follow instructions in Action List in order to
identify or eliminate the errors.
12
Wipe off the pipette tip carefully with a tissue. Remove the cover from the Pipette
Arm by pulling it from the back. Wipe off any fluid around the connection
between the tubing and the Pipette with a tissue.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

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Error Handling Phadia 100 - User Manual

#28.XX Position: [nn] CANNOT LEAVE FLUID

Sub code see Pipette R- position table.
What can cause the problem:
The level detector detects fluid when it is not supposed to. A droplet of fluid may
be stuck between the electrodes and the pipette aspirates air. There might be fluid
around the Pipette tubing connection.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Wipe off the pipette tip carefully with a tissue. Remove the cover from the Pipette
Arm by pulling it from the back. Wipe off any fluid around the connection
between the tubing and the Pipette with a tissue.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

#30.XX Position: [nn] CANNOT FIND SAMPLE

What can cause the problem:
This error indicates that the sample tubes may be out of fluid. The pipette goes
to the bottom of the tube and aspirates. Then it continues with the next position.
The pipette might not have aspirated the correct volume.
Depending on the sub-code different actions have to be taken:

#30.00
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Wipe off the pipette tip carefully with a tissue. Remove the cover from the Pipette
Arm by pulling it from the back. Wipe off any fluid around the connection
between the tubing and the Pipette with a tissue.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

#30.03
Corrective actions:
Contact your local Phadia representative.

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Phadia 100 - User Manual Error Handling

#31.XX Position: [nn] CANNOT FIND CONJUGATE

What can cause the problem:
This error indicates that the conjugate vial may be out of fluid. The pipette goes
to the bottom of the vial and aspirates. Then it continues with the next position.
The pipette might not have aspirated the correct volume.
Depending on the sub-code different actions have to be taken:

#31.00
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

#31.03
Corrective actions:
Contact your local Phadia representative.

#32.XX Position: [nn] CANNOT FIND DEVSOL

What can cause the problem:
This error indicates that the development solution vial may be out of fluid. The
pipette goes to the bottom of the vial and aspirates. Then it continues with the
next position. The pipette might not have aspirated the correct volume.
Depending on the sub-code different actions have to be taken:

#32.00 12
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

#32.03
Corrective actions:
Contact your local Phadia representative.

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Error Handling Phadia 100 - User Manual

#33.XX Position: [nn] CANNOT FIND STOP SOL

What can cause the problem:
This error indicates that the stop solution vial may be out of fluid. The pipette
goes to the bottom of the vial and aspirates. Then it continues with the next
position. The pipette might not have aspirated the correct volume.
Depending on the sub-code different actions have to be taken:

#33.00
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

#33.03
Corrective actions:
Contact your local Phadia representative.

ERROR #34.XX CANNOT FIND FLUOROC

What can cause the problem:
This error indicates that the FluoroC vial may be out of fluid. The pipette goes
to the bottom of the vial and aspirates. Then it continues with the next position.
The pipette might not have aspirated the correct volume.
Depending on the sub-code different actions have to be taken:

#34.00
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

#34.03
Corrective actions:
Contact your local Phadia representative.

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Phadia 100 - User Manual Error Handling

FATAL #36.00 NO LIQUID FOUND

What can cause the problem:
This error indicates that the vial of Maintenance Solution may be out of fluid.
The pipette goes to the bottom of the vial and aspirates. The pipette might not
have aspirated the correct volume.
Corrective actions:
Make sure that the vial of Maintenance Solution is placed in position G in the
Sample Carousel. Rerun the cleaning procedure.
If the error returns contact your local Phadia representative.

#37.XX Position: [nn] CANNOT FIND DILUENT

What can cause the problem:
This error indicates that the sample diluent vial may be out of fluid. The pipette
goes to the bottom of the vial and aspirates. Then it continues with the next
position. The pipette might not have aspirated the correct volume.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

#39.00 Position: [nn] SAMPLE TUBE EMPTY

What can cause the problem:
The level detector has detected fluid before aspiration but not afterwards when
it is leaving the sample tube. This warning indicates that the specified sample
tube may be out of fluid. The pipette might not have aspirated correct volume.
There might have been an air bubble in the sample tube which has been popped 12
when the Pipette tip went through it.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

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Error Handling Phadia 100 - User Manual

FATAL #40.00 Position: [nn] DILUENT VIAL/TUBE EMPTY

What can cause the problem:
The level detector has detected fluid before aspiration but not afterwards when
it is leaving the diluent vial or tube. This warning indicates that the diluent vial
or tube may be out of fluid. The pipette might not have aspirated correct volume.
There might have been an air bubble in the diluent vial or tube which has been
popped when the Pipette tip went through it.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

#41.00 Position: [nn] CONJUGATE VIAL EMPTY

What can cause the problem:
The level detector has detected fluid before aspiration but not afterwards when
it is leaving the conjugate vial. This warning indicates that the conjugate vial
may be out of fluid. The pipette might not have aspirated correct volume. There
might have been an air bubble in the conjugate vial which has been popped when
the Pipette tip went through it.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

#42.00 Position: [nn] DEVSOL VIAL EMPTY

What can cause the problem:
The level detector has detected fluid before aspiration but not afterwards when
it is leaving the development solution vial. This warning indicates that the
development solution vial may be out of fluid. The pipette might not have
aspirated correct volume. There might have been an air bubble in the develop-
ment solution vial which has been popped when the Pipette tip went through it.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

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Phadia 100 - User Manual Error Handling

#43.00 Position: [nn] STOP SOLUTION VIAL EMPTY

What can cause the problem:
The level detector has detected fluid before aspiration but not afterwards when
it is leaving the stop solution vial. This warning indicates that the stop solution
vial may be out of fluid. The pipette might not have aspirated correct volume.
There might have been an air bubble in the stop solution vial which has been
popped when the Pipette tip went through it.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

ERROR #44.00 FLUOROC VIAL EMPTY

What can cause the problem:
The level detector has detected fluid before aspiration but not afterwards when
it is leaving the FluoroC vial. This warning indicates that the FluoroC vial may
be out of fluid. The pipette might not have aspirated correct volume. There might
have been an air bubble in the FluoroC vial which has been popped when the
Pipette tip went through it.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
If the error remains contact your local Phadia representative.

ERROR #45.XX PRESSURE TOO LOW

Sub code see Assay step table.
What can cause the problem: 12
The pressure in the system is too low which has affected the reliability and thus
no results will be presented. This error might be caused by a mechanical
malfunction in the pressure system.
Corrective actions:
Contact your local Phadia representative.

#46.XX Position: [nn] CAN'T BE POS

This error indicates that the optical sensors have detected that a carousel has
moved to a wrong position.
Two different sub-codes exist:

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Error Handling Phadia 100 - User Manual

FATAL #46.05 CAP CAROUSEL MOTOR CAN'T BE POS

What can cause the problem:
The optical sensors have detected that the ImmunoCAP Carousel has moved to
the wrong position. This error might be caused by alluvion around the Drive
Plate of the ImmunoCAP Carousel.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Check/Remove if the movement of the ImmunoCAP Carousel has been ob-
structed. Check the processing chamber for loose ImmunoCAP/EliA Wells, look
under the Elution Wells Disc, check also under the Wash Rake. Clean the
processing chamber. If problem persist call service.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

FATAL #46.06 SAMPLE CAROUSEL MOTOR CAN'T BE POS

What can cause the problem:
The optical sensors have detected that the Sample Carousel has moved to the
wrong position.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Check/remove if the movement of the Sample Carousel has been obstructed.
Make sure that nothing is blocking the movement by rotating the Sample
Carousel. For Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the
instructions displayed to safely shut down the instrument. Switch the Phadia 100
off, wait 10 seconds and switch on again. Clean under the sample carousel if
needed.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

FATAL #50.00 LAMP VOLTAGE TOO LOW

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Phadia 100 - User Manual Error Handling

#51.XX LAMP VOLTAGE TOO HIGH

What can cause the problem:
The lamp voltage is too high. This error might be caused by a defect fuse or the
lamp beeing too old.
Depending on the sub-code different actions have to be taken:

WARN #51.00
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
If the error remains contact your local Phadia representative.

FATAL #51.01
Corrective actions:
Check fuse 905 and replace it.
Follow instructions in Action List in order to identify or eliminate the errors.
If the error remains contact your local Phadia representative.

FATAL #52.00 TOO LITTLE WASH LOADED

What can cause the problem:
To little wash loaded or insufficient Washing Solution distribution. Rinse
Solution could be contaminated.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Make sure that the tubing from the Washing and Rinse Solution bottles are not
twisted and that the tubings are properly connected to the bottles. To avoid
twisted tubes connect tubings after Washing and Rinse Solution bottles have
been recapped.
12
NOTE! When running ImmunoCAP Specific IgA or ImmunoCAP Specific IgG
with a full sample carousel, 1 l of Washing Solution is not enough. Fill up the
bottle with Washing Solution.
Check how much Washing and Rinse Solution is left. If the consumption is
unreasonably low, contact your local Phadia representative.
If the error remains contact your local Phadia representative.

FATAL #53.00 WASH/RINSE HAVE BEEN MIXED

What can cause the problem:
Washing Solution and Rinse Solution bottles or connections have been mixed or
Rinse Solution could be contaminated.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.

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Error Handling Phadia 100 - User Manual

Ensure that Washing Solution and Rinse Solution are properly prepared. The
Washing Solution Concentration is of big importance for several tests. Always
prepare according to Directions for Use. Always use purified water when
preparing Washing Solution and Rinse Solution.
Check that Rinse Solution is loaded in Rinse bottle and Washing Solution is
loaded in Washing Solution Bottle. Shake both Washing and Rinse Solution
bottle, the bottle with Washing Solution will foam.
If the error remains contact your local Phadia representative.

ERROR #54.00 INRUSH RELAY OFF

What can cause the problem:
The inrush current protection is not working properly.
Corrective actions:
For Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the instruc-
tions displayed to safely shut down the instrument. Switch Phadia 100 off.
Contact your local Phadia representative.

DATA
This error is caused by a malfunction during transfer of data in the internal
communication. An error message is printed underneath #ERROR in the section
PROCESS ERRORS on the Laboratory Report:

PROCESS ERRORS
POS-METHOD-TEST--SAMPLE ID----#ERROR DATA is printed here to indicate
The position in the ImmunoCAP an error
Carousel which is affected by
the error is printed here 01 GliG AGcal CAL-0.02 DATA
25 sIgE t3 32418 2

No data has been received by the reporting software. There will be no results
calculated and printed. If the data error concerns the curve controls the
calibration curve will still be valid and stored with status OK.
For Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the instruc-
tions displayed to safely shut down the instrument. Switch Phadia 100 off, wait
10 seconds and switch it on again. Rerun the results that have not been reported.
If the error remains contact your local Phadia representative.

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Phadia 100 - User Manual Error Handling

Assay Result Errors

Assay Result Errors may occur during the processing of an assay run. They are
divided into six different groups:
Calibration Curve Errors
Curve Control Errors
Quality Control Errors
Blank Errors
LOW RU Errors
FluoroC Errors
The Assay Result Errors are printed on different places on the reports depending
on the error group. At the end of the reports you find the Action Lists with
instructions on how to eliminate the errors.
You may receive more than one Assay Result Error or Assay Result Errors
together with Processing Errors. The instructions will then be combined into one
Action List.
Follow the instructions and perform the necessary steps. Do not empty the
instrument before you perform the actions listed on the Action List since this
might complicate identification of the cause of the error. A more detailed
information on each Assay Result Error is provided in this chapter.
Assay Result Errors are sometimes caused by one or more Processing Errors that
have occured during the assay run. Eliminating the Processing Errors can then
automatically lead to elimination of the Assay Result Errors.

Calibration Curve Errors

Calibration Curve Errors occur when the Calibration Curve is outside the limits,
if the CV is too high for the calibrator replicates or if the Calibration Curve is
too old. 12

Upper RU limit
RU
Ideal curve

Lower RU Limit

kU/l

If the Calibration Curve is outside the limits, the CV is too high or the Calibration
Curve is too old, you get NOT OK after Acceptance underneath Calibration
Information on the Laboratory Report.

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Error Handling Phadia 100 - User Manual

CALIBRATION INFORMATION
Calibration number: 23
Run date, time: 090507 16:15
Acceptance of the calibration Calibration code: 1P
curve used: Acceptance: NOT OK
OK Calibration curve Calculation type: Rodbard 4-parameters
accepted The Calibration Curve Errors are
FLAGGED Calibration curve CALIBRATOR ABOVE RANGE! printed here
flagged
NOT OK Calibration curve
not accepted
CURVE DATA

ITEM--------VALUE

ED-20 36.3
ED-50 84.8
ED-80 146
Slope 90.4

Response (RU)
100000 Graphic image of the calibration
Rejected calibrator point curve. If a point is rejected, it will
○

○
○

be printed as a cross
○

○
○

○

○
○

10000
○

○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
○

○
○

Estimated calibrator point

○

○
○

1000 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
○

○
○

100
2.00 5.00 15.0 100 200
Concentration (ug/l)

CALIBRATOR DATA

NAME------CONC--RESP--%CV--CALC--%CV

CAL-2.00 2.00 100 1.96

105 2.07
mean 103 3.7 2.01 3.8

CAL-5.00 5.00 293 5.19

Estimated response 261 4.71
mean 277 8.2 4.95 6.9 Estimated concentration

CAL-15.0 15.0 1126 15.5

CAL-100 100 9271 100

9042 97.5
mean 9156 1.8 98.8 1.9

CAL-200 200 15859 202

15867 202
mean 15863 0.0 202 0.1
Cont...

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Phadia 100 - User Manual Error Handling

NAME---------RESP----REMARK---------
Estimated and rejected response
values are printed here.
CAL-15.0 1126 Estimated
CAL-15.0 15721 Rejected
CAL-15.0 16048 Rejected

Example from a Laboratory Report:

For further information regarding the Calibration Curve assay, see
chapter 7, Monthly Calibration, and regarding the Laboratory Report, see
chapter 10, Printouts.

CV IS TOO HIGH FOR CALIBRATOR REPLICATES!

What can cause the problem:
In some cases, although there is no problem, the calculation will exclude a
replicate to get a better calibration fit. Pipetting or Wash problem can cause the
assay result error. For ImmunoCAP Specific IgA, ImmunoCAP Specific IgG,
ImmunoCAP Specific IgG4 and EliA insufficient Maintenance can cause the
error.
Corrective actions:
Check Action List with instructions on how to identify or eliminate the errors. For
additional information see Explanation of Actions, number, 18, 24, 26.
If the error remains contact your local Phadia representative.

LOWER PART OF CURVE IS TOO HIGH!

What can cause the problem:
In some cases, pipetting Stop Solution or problem with Washing Solution can
cause the assay result error. For ImmunoCAP Specific IgA, ImmunoCAP Specific
12
IgG, ImmunoCAP Specific IgG4 and EliA insufficient Maintenance or no
Washing Concentrate in Washing Solution also can cause the error. For EliA,
contamination problems can cause the problem (most likely contamination of
conjugate or CAL-0.0 vial with sample).
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 7, 18, 24, 25, 26, 27,
30, 32.
If the error remains contact your local Phadia representative.

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Error Handling Phadia 100 - User Manual

FLAT CALIBRATION CURVE!

What can cause the problem:
No Washing Solution going to the Wash Rake. For EliA, wrong Lot Specific
Code, no Washing Concentrate in Washing Solution or contamination prob-
lems (most likely contamination of conjugate with sample).
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 7, 18, 22, 24, 25,
26.
If the error remains contact your local Phadia representative.

CALIBRATOR ABOVE RANGE!

What can cause the problem:
Missed pipetting Stop Solution, mix-up of calibrator vials. For ImmunoCAP
Specific IgA, ImmunoCAP Specific IgG, ImmunoCAP Specific IgG4 and EliA
contamination problems (most likely contamination of calibrator vial with
sample). For EliA, wrong Lot Specific Code or used Specific IgG Conjugate, can
cause this error. Running Total IgE method using Specific IgE Conjugate can
give this error message.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 3, 4, 7, 18, 22, 24,
27, 30, 32.
If the error remains contact your local Phadia representative.

CALIBRATOR BELOW RANGE!

What can cause the problem:
Missed pipetting or mix-up of calibrator vials or problem with Rinse Solution
distribution. For EliA, there is a possibility that wrong Lot Specific Code has been
used or wrong storage conditions for EliA Wells. Missing adding Washing
Solution Additive to Washing Solution can lead to this message. Running
Specific IgE method using Total IgE Conjugate, can give this error message.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 3, 4, 7,8, 12, 18, 22,
24, 25, 26, 29.
If the error remains contact your local Phadia representative.

NO RISING TREND!
What can cause the problem:
Mix up between calibrators in the Sample Carousel, pipetting problem or
alluvion in the nozzles of the Wash Rake. For ImmunoCAP Specific IgA,

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Phadia 100 - User Manual Error Handling

ImmunoCAP Specific IgG, ImmunoCAP Specific IgG4 and EliA, contamination

problems.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 7, 22, 24, 38.
If the error remains contact your local Phadia representative.

CALIBRATION CURVE OLDER THAN RECOMMENDED

What can cause the problem:
The Calibration Curve is too old.
Corrective actions:
Run a new Calibration Curve in the next assay run.

Curve Control Errors

Curve Control Errors occur when Curve Controls are outside the inner limits of
the Calibration Curve.

If the Curve Controls are outside the inner limits, you get HIGH*, HIGH, LOW*
or LOW under Curve Controls on the Laboratory Report.

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Error Handling Phadia 100 - User Manual

Example from a Laboratory Report:

OK, HIGH, LOW, HIGH or LOW

The Curve Control Error is printed is printed here
here CURVE CONTROLS

NAME----RESP--%CV--CONC--%CV--JUDGED

CC-1 4696 0.51 HIGH

CC-2 988 0.096 LOW

CALIBRATION CURVE IS NOT OK

THE SAMPLE RESULTS ARE PROBABLY NOT OK

SEE ACTION LIST FOR CORRECTIVE ACTIONS

AND/OR JUDGEMENT OF RESULTS.

For further information regarding Curve Controls, see chapter 7, Monthly

Calibration, and regarding the Laboratory Report, see chapter 10, Printouts.

CC-1 HIGH and CC-2 HIGH

What can cause the problem:
No Washing Solution going through Wash Rake, or lack of Stop Solution. For
ImmunoCAP Specific IgA, ImmunoCAP Specific IgG and EliA, contamination
problems (most likely contamination of conjugate or CC vial with sample). For
EliA, wrong Lot Specific Code, no Washing Concentrate in Washing Solution or
using Specific IgG Conjugate can cause this error. Running Total IgE method
using Specific IgE Conjugate, can give this error message. For Specific IgE
method wrong Curve Controls can have been used.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 3, 7, 18, 22, 24, 25,
26, 27, 30, 32.
If the error remains contact your local Phadia representative.

CC-1 HIGH and CC-2 OK

What can cause the problem:
Insufficient wash or use of wrong Curve Control. For ImmunoCAP Specific IgA,
ImmunoCAP Specific IgG, ImmunoCAP Specific IgG4 and EliA it can also be a
contamination problem (most likely contamination of conjugate or CC vial with
sample).

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Phadia 100 - User Manual Error Handling

Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 7, 18, 24, 25, 26, 27.
If the error remains contact your local Phadia representative.

CC-1 HIGH and CC-2 LOW

What can cause the problem:
Mostly, switching Curve Controls. For ImmunoCAP ECP, ImmunoCAP Tryptase,
EliA this error is very uncommon and probably caused by more than one error.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 5, 7, 24.
If the error remains contact your local Phadia representative.

CC-1 HIGH and CC-2 HIGH*

What can cause the problem:
Insufficient wash. For ImmunoCAP Specific IgA, ImmunoCAP Specific IgG,
ImmunoCAP Specific IgG4 and EliA it also can be a contamination problem
(most likely contamination of conjugate or CC vial with sample). For EliA,
wrong Lot Specific Code.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 7, 18, 22, 24, 25,
26, 27, 30, 32.
If the error remains contact your local Phadia representative.

CC-1 HIGH and CC-2 LOW*

What can cause the problem: 12
Insufficient wash. For ImmunoCAP Specific IgA, ImmunoCAP Specific IgG,
ImmunoCAP Specific IgG4 and EliA it can also be a contamination problem.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 7, 18, 24, 26, 27.
If the error remains contact your local Phadia representative.

CC-1 LOW and CC-2 LOW

What can cause the problem:
Pipetting problem caused by lack of Rinse Solution and/or a dirty instrument. For
EliA, wrong Lot Specific Code or wrong storage conditions for EliA Wells.
Running Specific-IgE method and using Total-IgE Conjugate can give this error
message. Also running ImmunoCAP Total IgE method and using ImmunoCAP

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Error Handling Phadia 100 - User Manual

Specific IgE Curve Controls.

Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 4, 7, 18, 22, 24, 25,
26, 29.
If the error remains contact your local Phadia representative.

CC-1 LOW and CC-2 OK

What can cause the problem:
Wrong vial in CC-1 position. Pipetting problem caused by lack of Rinse Solution,
risk for a dirty instrument. For EliA, ImmunoCAP ECP and ImmunoCAP
Tryptase air bubbles in reagents is most possible cause.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 4, 7, 24.
If the error remains contact your local Phadia representative.

CC-1 LOW and CC-2 HIGH

What can cause the problem:
This error is very uncommon and is probably caused by more than one error.
Corrective actions:
No corrective actions proposed.
If the error remains contact your local Phadia representative.

CC-1 LOW and CC-2 LOW*

What can cause the problem:
Pipetting problem caused by lack of Rinse Solution, risk of a dirty instrument.
For EliA it is possible that wrong Lot Specific Code has been used or wrong
storage condition of EliA Wells.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 7, 18, 22, 24, 25,
26, 29.
If the error remains contact your local Phadia representative.

CC-1 LOW and CC-2 HIGH*

What can cause the problem:
This error is very uncommon and is probably caused by more than one error.

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Phadia 100 - User Manual Error Handling

Corrective actions:
No corrective actions proposed.
If the error remains contact your local Phadia representative.

CC-1 HIGH* and CC-2 HIGH*

What can cause the problem:
This error might be caused by improper placement of the instrument, but the
results might be acceptable. For EliA it can be a contamination problem (mostly
contamination of conjugate or CC vial whith sample) or wrong Lot Specific
Code.
Corrective actions:
It is recommended though, that the reliability of the results be judged using QC
results. For additional information see Explanation of Actions, number 7, 22, 26,
30, 32.
If the error remains contact your local Phadia representative.

CC-1 HIGH* and CC-2 LOW*

What can cause the problem:
This error is very uncommon and is probably caused by more than one error.
Corrective actions:
No corrective actions proposed, except for EliA methods.
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 7, 18, 24.
If the error remains contact your local Phadia representative.

CC-1 HIGH* and CC-2 HIGH

What can cause the problem:
12
For EliA it can be a contamination problem (mostly contamination of conjugate
or CC vial whith sample) or wrong Lot Specific Code. For other methods this
error is very uncommon and is probably caused by more than one error.
Corrective actions:
No corrective actions proposed, except for EliA methods.
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 7, 18, 22, 24, 25,
26, 27, 30, 32.
If the error remains contact your local Phadia representative.

CC-1 HIGH* and CC-2 LOW

What can cause the problem:
This error is very uncommon and is probably caused by more than one error.

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Error Handling Phadia 100 - User Manual

Corrective actions:
No corrective actions proposed, except for EliA methods.
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 7, 18, 24.
If the error remains contact your local Phadia representative.

CC-1 LOW* and CC-2 LOW*

What can cause the problem:
This error might be caused by inproper placement of the instrument but the
results might be acceptable. For EliA it is possible that wrong Lot Specific Code
has been used or wrong storage conditions of EliA Wells.
Corrective actions:
It is recommended though, that the reliability of the results be judged using QC
results.
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 7, 22, 26, 29.
If the error remains contact your local Phadia representative.

CC-1 LOW* and CC-2 HIGH*

What can cause the problem:
This error is very uncommon and is probably caused by more than one error.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Rerun the results that have not been reported. Check that sample volume is
enough including the sample tube dead volume, otherwise new patient sample
is needed. Use 1.1.Enter requests and put in the requests that have not been
reported.
If the error remains contact your local Phadia representative.

CC-1 LOW* and CC-2 LOW

What can cause the problem:
Pipetting problem. For EliA it is possible that wrong Lot Specific Code has been
used or wrong storage conditions of EliA Wells.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 7, 22, 24, 26, 29.
If the error remains contact your local Phadia representative.

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Phadia 100 - User Manual Error Handling

CC-1 LOW* and CC-2 HIGH

CC-1 OK and CC-2 HIGH

What can cause the problem:
Stop Solution Pipetting problem. Use of wrong Curve Control vial in CC-2
position. For EliA it can be a contamination problem (most likely contamination
of CC vial with sample).
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 4, 7, 18, 24.
If the error remains contact your local Phadia representative.

CC-1 OK and CC-2 LOW

What can cause the problem:
Pipetting problem. For methods with two Curve Controls use of wrong Curve
Control vial in CC-2 position. For EliA, Washing Solution Additive missing in
Washing Solution can lead to this message.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors. For 12
additional information see Explanation of Actions, number 4, 24, 26, 27.
If the error remains contact your local Phadia representative.

Quality Control Errors

If you are using Quality Controls you get limits and CV for the Quality Control
from the Quality Control kit. It is also possible for each laboratory to calculate
its own specific limits and CV. If these limits are exceeded you receive Quality
Control Errors.
When the results are outside the limits, you get HIGH or LOW underneath
Quality Control on the Laboratory Report.
Sometimes Quality Control Errors are caused by Processing Errors. By eliminat-
ing the Processing Errors you will then also eliminate the Quality Control Errors.

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Error Handling Phadia 100 - User Manual

Example from a Laboratory Report:

QUALITY CONTROLS
OK, HIGH or LOW is printed here
NAME----RESP--%CV--CONC--%CV--JUDGED

QC1 206 0.46 LOW

(t3)

QC1 203 0.45 LOW

(d1)
NAME----EXP CONC--S--LIMIT--MIN--MAX

QC1 5.00 0.00 3.0 2.70 6.30

QC1 0.00 0.00 1.0 2.00 5.00

Make sure that all reagents and samples are in their right positions according
to the Distribution List and contain sufficient fluid according to the Consumption
List.
If the error remains contact your local Phadia representative.

Quality Control HIGH

What can cause the problem:
Evaporation from QC bottle causing to high concentration in bottle. Problem
with Stop Solution pipetting. Wrong QC limits or wrong QC bottle used. Wrong
ImmunoCAP/EliA Well dispensed. For some EliA QCs (specially dsDNA) and
Gliadin QC results is sensitive to concentration of Washing Solution. For EliA
it is possible that wrong Lot Specific Code has been used. EliA QCs are designed
for single use only.
Corrective actions:
No corrective actions proposed in Action List , except for EliA methods.
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 17, 25, 26.
If the error remains contact your local Phadia representative.

Quality Control LOW

What can cause the problem:
Pipetting problem caused by that Washing and Rinse Solution distribution is
affected. Too small volume QC loaded (big dead volume in QC bottle) or air
bubbles in QC bottle. EliA QCs are designed for single use only. Wrong QC limits
or QC bottle used. Wrong ImmunoCAP/EliA Well dispensed. For EliA it is
possible that incorrect Lot Specific Code has been used or wrong storage
conditions of EliA Wells. For some QC results (specially EliA dsDNA) concen-
tration of Washing Solution is critical.

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Phadia 100 - User Manual Error Handling

Corrective actions:
No corrective actions proposed in Action List, except for EliA methods.
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 7, 17, 25, 26, 29.
If the error remains contact your local Phadia representative.

Quality Control CV IS TOO HIGH

What can cause the problem:
Problem with Pipetting or Washing can cause the assay result error. If not enough
volume loaded it also can cause pipetting problems.
Corrective Actions:
Run Monthly Maintenance.
If the error remains contact your local Phadia representative.

Blank Errors
Blank Errors might be detected when the instrument performs a Blank Check.
The Blank Check is also used to test the reagent blank, which is subtracted from
the results obtained in the assay run. The Blank Check tests the quality of the rinse
and the function of the cuvette and fluorometer.
The Blank Errors are specified underneath Remarks on the Laboratory Report.
At the end of the Laboratory Report you find the Action List with instructions on
how to eliminate the errors.
Example from a Laboratory Report:

The Blank Error is printed here

REMARKS
REAGENT BLANK IS TOO HIGH
The Blank value is printed here 12
(190)

SEE ACTION LIST FOR CORRECTIVE ACTIONS

Action List with instructions

on how to eliminate the error ACTION LIST
See User Manual, Index: Error handling Blanks
Discard the Development Solution vial

Perform Monthly Maintenance

Clean and dry (not with Paper tissue) Elution Wells Disc

Rerun with new fresh Development Solution vial

Avoid mixing up the Development Solution vial cap and the Conjugate vial cap
If Blank Error remain - Contact Phadia representative

0354, 090507 12:12, 2.3, 032

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Error Handling Phadia 100 - User Manual

REAGENT BLANK IS TOO HIGH

If the Reagent blank is >187.5 RU this error message will occur.
What can cause the problem:
This error might be caused by contamination of the Development Solution or the
Elution Wells Disc might need cleaning.
Normal values
For ImmunoCAP between 10 - 20 RU and for EliA between 15 - 35 RU.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 18, 19, 31.
If the error remains contact your local Phadia representative.

RINSE BLANK IS TOO HIGH

If the Rinse blank is > 31.25 RU this error will occur.
What can cause the problem:
This error might be caused by contamination of the Rinse Solution or that the
Rinse Bottle has been filled with the wrong solution. Dirty cuvette or Elution
Wells Disc can also cause the error.
Normal values
5 - 20 RU
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors.
Perform Monthly Maintenance as corrective action before next run in order to
clean the instrument. Monthly Maintenance should be done even if the regular
Monthly Maintenance has been done recently. Something has happened during
the run and the instrument needs to be cleaned, like after Rinse Solution and
Washing Solution distribution problems, lack of maintenance or vacuum
problems. After going trough all other actions on the list first and thereby
eliminate the error it could be that Monthly Maintenance can be skipped this
time.
If the error remains contact your local Phadia representative.

THE DIFFERENCE BETWEEN REAGENT BLANK

AND RINSE BLANK IS TOO LOW
What can cause the problem:
Broken cuvette. Rinse Solution or Washing Solution in both bottles. Rinse
Solution that is contaminated.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number, 11, 26.
If the error remains contact your local Phadia representative.

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Phadia 100 - User Manual Error Handling

DARK BLANK IS TOO HIGH

If the Dark blank is >15.625 RU this error will occur.
Normal values
5 - 10 RU
What can cause the problem:
This error might be caused by too much light in the Processing Chamber.
Corrective actions:
Make sure the instrument is not placed in direct sunlight.
If the error remains contact your local Phadia representative.

LOW RU Errors
LOW RU Errors occur when RU is less than 5, for the whole ImmunoCAP
Carousel or for a single position. If LOW RU is printed instead of results for
samples on the Laboratory Report, it means that you have a LOW RU Error.
This kind of error never occurs for calibrators, curve controls and Quality
Controls.
When a LOW RU Error occurs it will affect the assay run in different ways,
depending on where the error occurs. If the error concerns a calibrator, the
calibration curve will still be judged according to the criterias for curve
acceptance. If the error concerns a curve control, no patient results will be
reported, but the validity of the calibration curve will not be affected. If the error
concerns a sample only the result for that sample is affected.
The Reagent Blank value (RU) is printed underneath Remarks on the Laboratory
Report to help you check the Reagent Blank.
At the end of the Laboratory Report you find the Action List with instructions
on how to eliminate the errors.

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Error Handling Phadia 100 - User Manual

Example from a Laboratory Report:

SAMPLES
-TEST---RESP---CONC---CLASS---QUOT--
LOW RU is printed instead of the
response. No results are pre-
sented 32418
ImmunoCAP Specific IgE (kUA/l)
t3 LOW RU --.-- ----

33279
ImmunoCAP Specific IgE (kUA/l)
w6 1591 7.09 3

SEE ACTION LIST FOR CORRECTIVE ACTIONS

The Reagent Blank value is printed
REMARKS here

REAGENT BLANK VALUE (14)

SEE ACTION LIST FOR CORRECTIVE ACTIONS

Action List with instructions on
how to eliminate the error
ACTION LIST
See User Manual, Index: Error handling LOW RU
Check/remove misplaced ImmunoCAP/Wells in the ImmunoCAP Carousel
Check if Reagent Blank has increased. See Laboratory Report, REMARKS

Rerun the results that have not been reported

0354, 090507 10:12, 2.3, 032

LOW RU
Check the Reagent Blank under Remarks on the Laboratory Report. If the
Reagent Blank is higher than expected (>20 RU for ImmunoCAP and >35 RU for
EliA Wells), the error might be caused by insufficiently cleaned Elution Wells
Disc or that Stop Solution has not been pipetted at the end of the run.
If the reagent blank is higher than expected, perform a complete Daily
Maintenance.
Open the Processing Lid and check for any ImmunoCAP or EliA Wells blocking
the movement of the ImmunoCAP Carousel. If there is a misplaced ImmunoCAP
or EliA Well remove it. If the ImmunoCAP or EliA Wells are still in their inner
positions there is a mechanical malfunction.
If you have received LOW RU for all positions, load the assay run again by using
1.5.Load Old Run and rerun the samples.
If you have received LOW RU for some positions, rerun the results that have not
been reported.

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Phadia 100 - User Manual Error Handling

If the error remains contact your local Phadia representative.

Low RU, Whole carousel

What can cause the problem:
Cuvette broken. Missed pipetting because no Rinse Solution available or no
Conjugate, Development Solution or Stop Solution loaded. Stop Solution
loaded instead of Washing Solution Concentrate or Washing Solution Additive
instead of Development Solution.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 10, 11, 24.
If the error remains contact your local Phadia representative.

Low RU, Single position

What can cause the problem:
This error might be caused by contamination of the Development Solution or the
Elution Wells Disc might need cleaning. Missed pipetting of Conjugate or
Development Solution.
Missed ImmunoCAP/EliA Well dispensing. The Reagent Blank measured too
high caused by problems with Reagent distribution. For EliA missed raw serum
in serum dilution.
Corrective actions:
Follow instructions in Action List in order to identify or eliminate the errors. For
additional information see Explanation of Actions, number 7, 10, 12, 24.
If the error remains contact your local Phadia representative.

FluoroC Errors
12
FluoroC Errors may occur when you have performed a FluoroC run in order to
check the Fluorometer. If you get NOT OK on the FluoroC Run Report, which
is printed after the FluoroC run is finished, it means that you have a FluoroC
Error. At the end of the FluoroC Run Report you find the Action List with
instructions on how to eliminate the errors.

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Error Handling Phadia 100 - User Manual

Example of a FluoroC Run Report:

FLUOROC RUN
The Measurement status can be
OK or NOT OK
Run date, time: 090507 9:57
Measurement status: OK
Target value: DW (12500 RU)

RESULTS------------Value--Acceptance
FluoroC voltage 1: 3923.0 mV The FluoroC %CV can be OK or
FluoroC voltage 2: 3932.3 mV NOT OK
FluoroC voltage 3: 3946.1 mV
FluoroC Mean voltage: 3933.8 mV The Rinse Blank voltage can be
FluoroC %CV: 0.30 % OK OK or NOT OK
Rinse Blank voltage: 11.0 mV NOT OK

Final FluoroC voltage: 3929.8 mV The Deviation from target can be

Final FluoroC RU: 12280.5 RU OK or NOT OK
Deviation from target: -1.8 % OK

Action List with instructions on

how to eliminate the error
ACTION LIST
See User Manual, Index: Error handling FluoroC
Clean and dry (not with Paper tissue) Elution Wells Disc
Replace the Rinse with new fresh Rinse Solution before next run
Run Blanks, menu 6.9.5
Run FluoroC, menu 6.9.3.1
If FluoroC Error remain - Contact Phadia representative

0354, 090507 10:12, 2.3, 032

Measurement status: NOT OK

If you get NOT OK after Measurement status on the FluoroC Run Report, rerun
FluoroC using new room temperated vials of FluoroC and Stop Solution.
If the error remains contact your local Phadia representative.

Rinse Blank voltage: NOT OK

If you get NOT OK after Rinse Blank Voltage on the FluoroC Run Report the
Elution Wells Disc might need cleaning.
Clean and dry Elution Wells Disc.
Replace the Rinse before next assay run.
Run 6.9.5.Run Blanks. For further instructions see chapter 11, Maintenance.
Rerun FluoroC using new room temperated vials of FluoroC and Stop Solution.
Make sure to put the correct cap onto the correct vial to avoid carry over.
If the error remains contact your local Phadia representative.

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Phadia 100 - User Manual Error Handling

FluoroC %CV: NOT OK

If you get NOT OK after FluoroC %CV on the FluoroC Run Report the
instrument might have run out of FluoroC solution during the FluoroC run or
there might be a problem with the pipette.
Make sure that the tubings from the Washing Solution and Rinse Solution
Bottles are not twisted and that the tubings are properly connected to the bottles.
Perform a complete cleaning procedure according to Monthly Maintenance. For
further instructions see chapter 11, Maintenance.
Rerun FluoroC using new room temperated vials of FluoroC and Stop Solution.
If the error remains contact your local Phadia representative.

Deviation from target: [±4-10%] NOT OK

If you get NOT OK after Deviation from Target on the FluoroC Run Report and
the deviation is between 4% and 10% or -4% and -10%, rerun FluoroC using
new room temperated vials of FluoroC and Stop Solution.
If the error remains contact your local Phadia representative.

Deviation from target: [>+10% or <-10%] NOT OK

If you get NOT OK after Deviation from Target on the FluoroC Run Report and
the deviation is more than 10% or less than -10%, the instrument might be out
of Stop Solution.
Make sure that the tubings from the Washing Solution and Rinse Solution Bottles
are not twisted and that the tubings are properly connected to the bottles.
Run 6.9.6.Selftest. For further instructions see chapter 11, Maintenance.
Clean and dry Elution Wells Disc.
Rerun FluoroC using new room temperated vials of FluoroC and Stop Solution.
If the error remains contact your local Phadia representative.

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Error Handling Phadia 100 - User Manual

Explanation of Actions

1 Check that there is enough space under instrument

Do not tighten the feet of the instrument too much. Leave about 8-12 mm of
threads visible. If the feet are screwed on too tight this will cause problem with
temperature regulation and transferring of used ImmunoCAP/EliA Well to
ImmunoCAP/EliA Well Waste Container. Make sure that the ImmunoCAP/EliA
Well Waste Container is not touching the table.

2 Check/remove if the movement of the Sample Carousel

has been obstructed
Make sure that nothing is blocking the movement by rotating the Sample
Carousel. For Phadia 100 Ver.3.0, use the menu 6.13.Shutdown and follow the
instructions displayed to safely shut down the instrument. Switch Phadia 100 off,
wait 10 seconds and switch on again. Clean under the sample carousel if needed.

3 Check that the correct conjugate has been used

Check reagents used before unloading them from instrument. Print Distribution
List if not already printed Check that right method conjugate is in right position
according to Distribution List. Check that the Cal Code printed on Laboratory
Report is the same as on the bottle in the Conjugate position in the sample
carousel. Always check that the assay run is loaded according to the Distribu-
tion List.

4 Check that right reagents are in the correct posi-

tion
Check reagents used before unloading them from instrument. Print Distribution
List if not already printed. Check that right reagents are in right position
according to Distribution List. Always check that the assay run is loaded
according to the Distribution List.

5 Check mix-up of CC1 and CC2. If mix-up confirmed, re-

evaluate
Make sure that you have not mixed up the vials for Curve Control 1 and Curve
Control 2 in the Sample Carousel. If they are mixed up the results need to be re-
evaluated. Print a new Laboratory Report in 3.2.Print Laboratory Report.
Switch Curve Controls.

6 Check Tubings:Connections and that they are not twisted

Make sure that the tubing from the Washing and Rinse Solution bottles are not
twisted and that the tubings are properly connected to the bottles. To avoid
twisted tubes, connect tubings after Washing and Rinse Solution bottles have

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Phadia 100 - User Manual Error Handling

been recapped. Check that the tubings to the bottle filters are connected properly.
See Chapter 11, Semiannual Maintenance.

7 Check Wash/Rinse: Consumption, Tubings:Connections

and that they are not twisted
Make sure that the tubing from the Washing and Rinse Solution bottles are not
twisted and that the tubings are properly connected to the bottles. To avoid
twisted tubes connect tubings after Washing and Rinse Solution bottles have
been recapped.
NOTE! When running ImmunoCAP Specific IgA or ImmunoCAP Specific IgG
with a full sample carousel, 1 l of Washing Solution is not enough. Fill up the
bottle with Washing Solution.
Check how much Washing and Rinse Solution is left. If the consumption is
unreasonably low, contact your local Phadia representative.

8 Check/clean the Pipette tip - See User Manual,

Index: Pipette, clean
See Processing Errors #27.XX and #28.XX in this chapter.

9 Check/Remove if the movement of the ImmunoCAP Car-

ousel has been obstructed
Check the processing chamber for loose ImmunoCAP/EliA Wells, look under the
Elution Wells Disc check also under the Wash Rake. Clean the processing
chamber. If problem persist call service.

10 Check/remove misplaced ImmunoCAP/Wells in the

ImmunoCAP Carousel
Open processing lid carefully to see that all ImmunoCAP/EliA Wells are in the
inner position of the ImmunoCAP holder disc. If the positioning is not correct for
one ImmunoCAP/EliA Well but it is in the right line, correct the positioning after
checking that the identity is correct according to the Distribution List. Put in new
12
ImmunoCAP/EliA Wells manually if the identity is not possible to check or
several ImmunoCAP/EliA Wells are loose.

11 The Cuvette is probably broken

Check visually if the Cuvette is broken. Is the Cuvette broken, clean up the
Processing Chamber. Make sure there is no glass in the process chamber, check
Elution Wells Disc, lift up and look underneath also. Look for misplaced
ImmunoCAP/EliA Well on Elution Wells Disc, under Elution Wells Disc and
under Wash Rake. If ImmunoCAP/EliA Well is found, that is probably the
cause. If ImmunoCAP not dispensed and Check ImmunoCAP Dispense have
occurred prior to this error situation. That can be an indication of future

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Error Handling Phadia 100 - User Manual

problems when there has been ImmunoCAP Dispense errors. Always check that
no misplaced ImmunoCAP/EliA Well is in the Processing Chamber after this
error message. Always empty the ImmunoCAP Waste Container after every
run.

12 Check if Reagent Blank has increased. See Labora-

tory Report, REMARKS
See Chapter 12. Compare value printed on Laboratory Report with normal
values under Reagent blank is too high in this chapter.

13 Check for any ImmunoCAP/Well blocking the movement

Check the processing chamber for loose ImmunoCAP/EliA Wells, look under
the Elution Wells Disc check also under the Wash Rake.

14 Check if the fan in the top box is running

Check by holding the hand on the back of the instrument upper left side. If no air
stream the fan has stopped.

15 Check/replace fuse F904 and F906

Please read Chapter 11, Replace fuses.

16 Check /replace fuse F905

Please read Chapter 11, Replace fuses.

17 Check Lot Specific Code for EliA Wells

Check on Laboratory Report that right Lot Specific Code has been used.
Lot Specific Code is written for every EliA Well position.

18 Perform Monthly Maintenance

Perform Monthly Maintenance as corrective action before next run in order to
clean the instrument. Monthly Maintenance should be done even if the regular
Monthly Maintenance has been done recently. Something has happened during
the run and the instrument needs to be cleaned, like after Rinse Solution and
Washing Solution distribution problems, lack of maintenance or vacuum
problems. After going trough all other actions on the list first and thereby
eliminate the error it could be that Monthly Maintenance can be skipped this
time.

19 Clean and dry (not with Paper tissue) Elution Wells

Disc
See Chapter 11 Cleaning of the process chamber.

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Phadia 100 - User Manual Error Handling

20 Empty instrument manually and run Monthly Maintenance

Unload Sample Carousel, open Processing lid and lift up ImmunoCAP holder
disc. Throw away ImmunoCAP or EliA Wells. Check that no ImmunoCAP or
EliA Wells are left in or under the Elution Wells Disc. Check also under Wash
Rake. After emptying the instrument, perform a complete Monthly Mainte-
nance, see Chapter 11.

21 Check if Wash Sol/Rinse have been mixed

Shake gently both Washing and Rinse Solution bottles, the bottle with Washing
Solution will foam.

22 Check Lot Specific Code for calibrator EliA wells

Check on Laboratory Report that right Lot Specific Code has been used. Lot
Specific Code is written for every EliA Well position.

23 Load old run and rerun Samples

Check that sample and reagent volumes are enough for the rerun. Look at
consumption list and include dead volume for the sample tubes. Rerun the
results that have not been reported. Load the assay run again by first using
1.5.Load Old Run.

24 Rerun the results that have not been reported

Check that sample volume is enough including the sample tube dead volume,
otherwise new patient sample is needed. Use 1.1.Enter requests and put in the
requests that have not been reported.

25 Replace the Washing Solution and the Rinse Solu-

tion before next run
Clean the bottles thoroughly before preparing new fresh solutions.
12
26 Ensure that Wash Sol/Rinse are properly prepared
The Washing Solution Concentration is of big importance for several tests.
Always prepare according to Directions for Use. Always use purified water
when preparing Washing Solution and Rinse Solution.

27 Rerun with new fresh Conjugate vial

Rerun the results that have not been reported. Load the assay run again by first
using 1.5.Load Old Run. If only part of the assay run is not approved, patient
requests need to put in once again 1.1.Enter Requests. Avoid contamination of
conjugate vial with sample. See Chapter 3, Reagent and Sample Handling.

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Error Handling Phadia 100 - User Manual

28 If the error remains, perform Monthly Maintenance

It is essential to have a clean instrument for good performance and accepted
results.This should be done even if Monthly Maintenance has been done
recently on regular basis. Go to Chapter 11 and perform according to instruc-
tion.

29 Ensure proper storage conditions for EliA wells

EliA Wells have to be put back into the foil bag immediately after use. The
desiccant bags have to remain in the foil bag, and the zip lock has to be closed
properly. The EliA Wells have to be stored refrigerated. Storage of EliA Wells
in a ImmunoCAP-Rack is not permissible.

30 Avoid contamination of conjugate, calibrators and

curve control by serum sample
See Chapter 3, Reagent and Sample Handling.

31 Avoid mixing up the Development Solution vial cap

and the Conjugate vial cap
Small amounts of Conjugate coming in contact with the Development Solution
affects the background signal of the Development Solution. Residues of conju-
gate on the vial cap is enough to affect the Development Solution function next
time it will be used.

32 Avoid touching the threads of the vials

After handling samples change to new gloves.

33 Daily Maintenance is an important procedure in

order to keep the instrument in good condition
Always perform Daily Maintenance, read instruction in Chapter 11. Daily
Maintenance should be performed after last run each day, in order to prevent
adherence of residuals of sample, reagents and Washing Solution to instrument
parts. Insufficient Maintenance can cause problems with ImmunoCAP Carousel
movements and problems with contamination of Calibrators and Curve Controls
for IgG and IgA methods.

34 The System pressure has been too low to ensure the

reliability of the results
Contact your local Phadia representative.

35 If no other error messages except #10,#11,#12 -

Contact your local Phadia representative.

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Phadia 100 - User Manual Error Handling

36 Check if Washing Solution is loaded

Shake Washing Solution bottle gently. The bottle with Washing Solution will
foam. Make sure bottle connection is ok.

37 Check that Rinse Solution is loaded in Rinse bottle

and Washing Solution is loaded in Washing Solution Bottle
Shake both Washing and Rinse Solution bottle, the bottle with Washing Solution
will foam.

38 Check mix-up between calibrators

Check reagents used before unloading from instrument. Print Distribution List if
not already printed. Check that right reagents are in assigned position according
to Distribution List. Always compare loaded run to Distribution List.

39 Check serum sample for IgA deficiency

If a "Low RU" message occurs in an EliA IgA test, this is a strong hint for IgA
deficiency, which is relatively frequent in celiac disease patients. In such samples
the total IgA level should be determined and EliA Celikey IgG and/or EliA
Gliadin IgG should be tested, if celiac disease is suspected.

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Error Handling Phadia 100 - User Manual

Mechanical and Electrical Malfunction

The operator might on some occasions face practical problems that provide no
information from the instrument. These problems are often of mechanical or
electrical kind. Please read the instructions below before you contact your local
Phadia representative.

No Power On
If you switch Phadia 100 on and the power LED to the right of the display is not
lit up, check that the mains power cord is connected and that the cord is
undamaged. Connect or replace the cord if necessary.
Check that the fuses are not blown. Replace blown fuses, see chapter 11,
Maintenance.
If the error remains contact your local Phadia representative.

No Display Text
If you cannot see any text on the display, check that the power is switched on and
that the power LED is lit. If the power LED is not lit, check that the mains power
cord is connected and that the cord is undamaged. Connect or replace the cord
if necessary.
Check that the fuses are not blown. Replace blown fuses, see chapter 11,
Maintenance.
The contrast setting might be to bright. Press the mode key and keep it pressed
down, then press the enter key. First release the mode key, and then the enter
key. This will set the contrast to default.
If the error remains contact your local Phadia representative.

Communication Errors
Communication errors may occur in communication between the internal PC,
the keyboard, and the process controller. Phadia 100 may also be connected to
an external computer. The communication parameters may not be the same in
Phadia 100 as in the connected equipment.
Check the following parameters:
• Baud rate
• Parity
• Data bits
• Stop bits

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Phadia 100 - User Manual Error Handling

For more information see Communication Parameters, chapter 1, Instrument

Specification and Installation, and Phadia IDM User Manual.
Check that the communication cables are properly connected and not damaged.
Connect or replace the cables if necessary.
If the error remains, please contact your local Phadia representative.

No Print Out
If you do not receive a printout, check that the instrument has not run out of
paper. Load a new paper roll if necessary, see chapter 11, Maintenance. If there
is paper in the printer switch Phadia 100 off, wait 10 seconds and switch it on
again.
If the error remains contact your local Phadia representative.

Bad Print Out

If there is no text on the printout or the text is difficult to read, check the printer
contrast setting, see chapter 2, Routine Assay Run. Be sure that the right side of
the paper is facing up, see chapter 11, Maintenance.
If the error remains contact your local Phadia representative.

Leakage
If process chamber is overflowing, check the drainage filter. Clean or replace the
drainage filter according to chapter 11, Maintenance.
If the error remains contact your local Phadia representative.

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Error Handling Phadia 100 - User Manual

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Phadia 100 - User Manual Repacking

Chapter 13 - Repacking
This chapter describes the cleaning report
and the repacking instructions

Repacking 2
Cleaning Report 2
Phadia 100 Cleaning Report 2
Repacking Instructions 3

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Repacking Phadia 100 - User Manual

Repacking

Cleaning Report
In order to obtain a good safety against transmission of infectious diseases, please
make a copy of the cleaning report and fill it in every time you send Phadia 100
to another operator or to Phadia AB.
The cleaning report shows the receiver that Phadia 100 was cleaned according to
the manual before it was repackaged and transported.
Perform the cleaning procedure in accordance with Monthly Maintenance in
chapter 11, Maintenance and make notes on the Cleaning Report. If everything
is in order, please write OK in the corresponding squares on the Cleaning Report.
Do not forget to put your signature on the Cleaning Report.
Please, copy this form and use it!

Phadia 100 Cleaning Report

Phadia 100 serial number:

Cleaned according to the X Sign Notes

Phadia 100 User Manual

Processing Chamber

ImmunoCAP Carousel

Bottles (Waste container-Biohazard

label removed)

Sample Carousel Compartment

Wash Rake and pipette

Outside

Phadia 100 has not been used

with patient samples

Phadia 100 Instrument has been cleaned according to the Phadia 100 User Manual and
the accessories box is repacked and included in the Package Box.
Date ________________________________________
Company ________________________________________
Address ________________________________________
City ________________________________________
Country ________________________________________
Signature ________________________________________
Name (block letters) ________________________________________

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Phadia 100 - User Manual Repacking

Repacking Instructions

1. Take out the ImmunoCAP Waste Con- 2. Make sure the Washing Solution, Rinse Solution and
tainer from the Processing Chamber. Empty Waste Bottles are empty.
it and put it in the accessory box.
Remove the Biohazard label from the Waste Container.
Take out the Elution Wells Disc and the
Fasten the Sample Carousel Cover, the Printer Lid and the
ImmunoCAP Holder Disc from the process-
Rinse Solution, Washing Solution and Waste Bottles with
ing chamber and put them in the accessory
tape.
box.
Remove the Sample Carousel from the in-
strument and put it in the accessory box.

3. Put the cushion under the Pipette Arm. Place it on the

Sample Carousel Cover and fasten it with tape.

4. Put tape around the instrument to re- 5. Place the instrument on a table, resting on its back
duce vibration during tranportation. Start at side. Unscrew the four feet from the bottom and remove
the back, continue over the front and fasten them.
it under the instrument.
Instrument feet

6. Screw the spacers to the

instrument before attaching
the bottom plate. Use the four 13
hexagonal screws you find in
the plastic bag to attach the
bottom plate to the instru- Hexagonal screws
ment. Wooden bottom plate
Spacer (between the wooden
bottom plate and the instrument)

T a b l e

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Repacking Phadia 100 - User Manual

7. Fasten the Cleaning 8. Lift the instrument by

Report on the instrument the carrying handles and
with tape. Put the plastic place it on the bottom plate
cover over the instrument. of the plywood box.
NOTE! This step requires
two persons.

9. Place the four spacing

collars in their positions. Put Accessory box
the accessory box in its place.
Lift the plywood box over
the instrument.
Attach the plywood box to
the bottom plate using the
metallic clips. Put the top on
the box and attach it with
the remaining metallic clips.

Spacing collars

10. Place the Cleaning Report as well on the package box as inside the box.

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Phadia 100 - User Manual Accessories

Chapter 14 - Accessories
This chapter notes the different
accessories, spare parts and supplement
products to Phadia 100

Accessories for Maintenance 2

Spare Parts 2
Supplement Products 2
Barcode Reader 2

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Accessories Phadia 100 - User Manual

Accessories for Maintenance

Bottle Filters with Tubing (pack of 2) 12-3505-11
CheckCAP (pack of 100) 12-3403-14
Drainage Filter (pack of 5) 12-3500-75
Fuse Kit 12-3500-99
ImmunoCAP Maintenance Solution Kit 10-9476-01
Printer Paper (2 rolls) 12-3501-05
Vacuum Grease 12-3505-12

Spare Parts
Bottles (Wash, Rinse, Waste) 12-3500-84
Elution Wells Disc 12-3501-07
ImmunoCAP Holder Disc 12-3501-06
ImmunoCAP Waste Container
(Instrument no. <287) 12-3500-95
ImmunoCAP Waste Container Rev. 2
(Instrument no. >287) 12-3505-19
Mains Kit 100/120V 12-3500-82
Mains Kit 230/240V 12-3500-83
Pipette Arm Cover 12-3500-81
Sample Carousel 12-3500-85
Sample Carousel Cover 12-3500-88

Supplement Products
Phadia Information Data Manager 12-3801-01
Data Cable (Phadia 100-Phadia 100) 12-3500-94

Barcode Reader
A barcode reader can be connected to Phadia 100. The barcode reader must be
able to read codes 39 and 93, be of RS-232 type, have its own power supply, send
decoded data as ASCII-text followed by CR (carriage return) and LF (line feed),
and it must be CE-marked.
To connect a barcode reader of USB type, please contact your local Phadia
representative.

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Phadia 100 - User Manual Index

Chapter 15 - Index

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Index Phadia 100 - User Manual

A Bottle
Cleaning 11.6
Abort Rinse Solution 1.2
Prepared Run 4.39 1.6
Process 4.44 Washing Solution 1.2
1.6
ACCESS DENIED 12.5
Waste 1.2
Accessories 14.2 1.6
Accessory Box 1.15
1.16 C
Accuracy Calibration Code 2.31
Pipette volume 1.10 2.45
Washing solution 1.10
Calibration Curve Error 12.37
Action List 10.17
12.6 CALIBRATION CURVE OLDER
12.14 THAN RECOMMENDED 12.41
Explanations 12.55 CALIBRATOR
Active Calibrators ABOVE RANGE 12.40
BELOW RANGE 12.40
Set 6.9
Add Calibrator Point
Edit 6.11
Article 9.34
Method 9.4 Calibrators
Quality Control 4.20 Accept 6.10
Test 4.15 Delete 4.8
Test Panel 9.30 Edit 6.9
Air Pressure 1.9 Export 6.13
Handling 3.2
ALREADY IN FLUID 12.26 Print 6.8
Article Printout 10.11
Add 9.34 CANNOT CREATE FILE 12.5
Delete 9.36
CANNOT FIND
Edit 9.35
CONJUGATE 12.28
Assay Result Error 12.37 DEVSOL 12.28
DILUENT 12.30
B FLUOROC 12.29
SAMPLE 12.27
Bar Code Reader 2.31 STOP SOL 12.29
14.2 CANNOT LEAVE FLUID 12.27
BENT PIPETTE 12.25 CAN'T FIND FLAG 12.21
Biohazard label 1.13 CAN'T POS FLAG 12.23
1.19
Placement 1.20 CAP CAROUSEL MOTOR
BENT PIPETTE 12.26
BLANK CHECK ERROR 12.11 CAN'T BE POS 12.33
Blank Error 12.49 CAN'T FIND FLAG 12.22
Disable 5.9 CAN'T POS FLAG 12.24
Blank Report 10.17 NOT CALIBRATED 12.20
NOT INITIALIZED 12.20
12.11
OUT OF RANGE 12.23
Blank Run 11.15

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Phadia 100 - User Manual Index

CAP TRANSFER MOTOR Communication Error 12.61

CAN'T FIND FLAG 12.23 Communication Parameters 1.25
CAN'T POS FLAG 12.25
NOT CALIBRATED 12.20 Conjugate Handling 3.2
NOT INITIALIZED 12.20 CONJUGATE VIAL EMPTY 12.31
OUT OF RANGE 12.23
Consumption List 10.4
Capacity 1.8
Contrast 1.23
Carousel
Control Charts 8.7
ImmunoCAP 1.6
Sample 1.4 Control Samples 8.4
CC-1 HIGH and CC-2 HIGH* 12.42 CONTROLLER BOARD
CC-1 HIGH and CC-2 HIGH 12.42 TEMPERATURE TOO HIGH 12.8
CC-1 HIGH and CC-2 LOW* 12.43 CONTROLLER HALTED 12.19
CC-1 HIGH and CC-2 LOW 12.42 Cooling Fan 1.3
CC-1 HIGH and CC-2 OK 12.42 Cover
Sample Carousel 1.2
CC-1 HIGH* and CC-2 HIGH* 12.44
Curve Control Error 12.41
CC-1 HIGH* and CC-2 HIGH 12.45
Curve Control-Log
CC-1 HIGH* and CC-2 LOW* 12.44 Edit 6.6
CC-1 HIGH* and CC-2 LOW 12.45 Export 6.13
Print 6.4
CC-1 LOW and CC-2 HIGH* 12.44
Printout 10.15
CC-1 LOW and CC-2 HIGH 12.43
Curve Controls 2.31
CC-1 LOW and CC-2 LOW* 12.44 Disable 5.8
CC-1 LOW and CC-2 LOW 12.43 Handling 3.2
Switch 5.7
CC-1 LOW and CC-2 OK 12.43
CV % values
CC-1 LOW* and CC-2 HIGH* 12.45 Calculation 2.26
CC-1 LOW* and CC-2 HIGH 12.46 CV IS TOO HIGH FOR
CC-1 LOW* and CC-2 LOW* 12.45 CALIBRATOR REPLICATES 12.39
CC-1 LOW* and CC-2 LOW 12.46
D
CC-1 OK and CC-2 HIGH 12.46
CC-1 OK and CC-2 LOW 12.47 Daily Maintenance 11.3
Change DAILY MAINTENANCE NOT
Dilution 4.3 PERFORMED 12.10
Quality Control with New Lot 4.35
Daily Rinse 11.3
Replicate 4.4
Sample ID 4.5 DARK BLANK IS TOO HIGH 12.13
Test 4.11 12.50
4.20 Disable 5.9
CHECK Data
CAPS ON VIALS 12.9 Evaluation 5.2
EliA WELL DISPENSE 12.8 Export 5.13
ImmunoCAP DISPENSE 12.8 Import 5.15
Cleaning Report 13.2 Date 1.21 15
CODE FF EXECUTED 12.18 Dead Volume 3.8

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Index Phadia 100 - User Manual

Default Method 1.22 Electrical Safety

Delete Classification 1.11
Article 9.36 ImmunoCAP 100E 1.11
Calibrators 4.8 UniCAP 100 1.11
Method 9.25 Electro Magnetic Compatibility
Request Data 4.40 ImmunoCAP 100E 1.11
Sample ID 4.7 UniCAP 100 1.11
Test 4.18 EliA Well
Test Panel 9.33
Dispenser 1.2
Development Solution Handling 3.2 1.5
Deviation from target 12.54 Remove 4.41
Remove All 4.43
DEVSOL VIAL EMPTY 12.32 Skip Loading 4.36
Diluent Handling 3.2 Specification 1.12
DILUENT VIAL/TUBE EMPTY 12.31 Waste Container 1.2

Dilution 3.9 EliA WELL NOT DISPENSED 12.8

Change 4.3 Elution Wells Disc 1.6
Dimensions 1.8 Cleaning 11. 4

Disable Enter Data 2.3

Blank Error 5.9 Enter Request 2.32
Curve Controls 5.8 2.38
Fatal Error 5.9 Environmental Conditions 1.9
Diskette Drive 1.2 1.17
1.5 Error
Dispenser Assay Result 12.37
EliA Well 1.2 Blank 12.49
1.5 Blank Check 12.11
ImmunoCAP 1.2 Calibration Curve 12.37
1.5 Communication 12.61
Display 1.2 Curve Control 12.41
FluoroC 12.53
Distribution List 10.5 LOW RU 12.51
Drainage Filter 1.2 Preparation 12.6
Replacement 11.12 Processing 12.14
Quality Control 12.47
E Error Case Description
Assay Result Error 12.37
Edit Blank Check Error 12.11
Article 9.35 Blank Error 12.49
Calibrator Point 6.11 Calibration Curve Error 12.37
Calibrators 6.9 Curve Control Error 12.41
Curve Control-Log 6.6 FluoroC Error 12.53
Method 9.5 LOW RU Error 12.51
Quality Control 4.25 Preparation Error 12.6
Quality Control-Log 6.5 Processing Error 12.14
Request 4.2 Quality Control Error 12.47
Test Panel 9.31
Error Handling 12.2
Electrical Malfunction 12.61 Blanks 12.49

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Phadia 100 - User Manual Index

Calibration Curve 12.37 I

Curve Control 12.41
FluoroC 12.53 IDM 1.7
LOW RU 12.51 2.31
Quality Control 12.47
ImmunoCAP 1.12
Error Messages 2.5 2.30
Evaporation 3.2 Remove 4.41
Export Remove All 4.43
Calibrators 6.14 Skip Loading 4.36
Curve Control Logs 6.13 ImmunoCAP 100 2.30
Data 5.13 ImmunoCAP Carousel 1.2
Method 9.27
1.6
Quality Control-Logs 6.12
Installation 1.19
Extranet 8.11
ImmunoCAP CAROUSEL IS
F NOT PRESENT 12.7
ImmunoCAP Dispenser 1.2
Fatal Error 1.5
Disable 5.9 ImmunoCAP Holder Disc 1.6
FILE Cleaning 11.4
INVALID 12.5 ImmunoCAP NOT DISPENSED 12.7
NOT FOUND 12.5
ImmunoCAP Waste Container 1.2
FLAT CALIBRATION CURVE 12.39
1.7
FluoroC Emptying 11.4
%CV 12.54 Installation 1.18
Error 12.53
Import
Handling 3.2
Data 5.14
Run 11.17
Method 9.28
Run Report 10.18
INC EXCEEDED WITH 12.20
FLUOROC VIAL EMPTY 12.32
INRUSH RELAY OFF 12.35
FLUOROMETER MOTOR
CAN'T FIND FLAG 12.22 Installation 1.15
CAN'T POS FLAG 12.24 Instructions 1.17
NOT CALIBRATED 12.20 Instrument
NOT INITIALIZED 12.20 Capacity 1.8
OUT OF RANGE 12.23 Dimensions 1.8
Fuses Front 1.2
Installation 1.18 Guide 1.2
Primary 1.3 Installation 1.15
1.8 Lifting Points 1.4
Replacement 11.20 Placement 1.17
Secondary 1.3 Rear 1.3
1.8 Specification 1.8
Weight 1.8
H Instrument Dilution 3.9
Heat Contribution 1.9 Instrument Event Log 9.37
Humidity 1.9 Instrument Panel 2.7 15

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Index Phadia 100 - User Manual

Instrument Performance Mechanical Malfunction 12.61

Verification 2.16 MEDIA
Intended Use 1.7 ERROR 12.4
Interface 1.9 FULL 12.4
NOT INSERTED 12.4
INTERNAL ERROR 12.10 WRITE-PROTECTED 12.4

L Menu Structure 2.9

Messages 2.4
Laboratory Report 10.6 12.4
Print 5.5
Method
LAMP VOLTAGE Add 9.4
TOO HIGH 12.7 Default 1.22
12.34 Delete 9.25
TOO LOW 12.7 Edit 9.5
12.34 Export 9.27
Language 1.22 Import 9.29
Print 9.26
Leakage 12.62 Printout 10.19
Lifting Points 1.4 Setup 9.2
Limitations 1.13 Method Summary 10.16
Liquid Containers Monthly Calibration 2.31
Volume 1.10 7.2
Load and Start 2.33 Monthly Maintenance 11.7
2.42 Monthly Maintenance Procedure 11.7
Load Old Run 4.37 MONTHLY MAINTENANCE
Log NOT PERFORMED 12.10
Maintenance 11.25 Monthly Report 8.12
LOW RU 10.8
12.51 N
LOWER PART OF CURVE IS
New Method
TOO HIGH 12.39
Select 4.9
Lubrication of O-rings 11.9
No Display Text 12.61
M NO LIQUID FOUND 12.30
NO METHODS DEFINED 12.5
Main Power Supply 1.8
No Power On 12.61
Maintenance 2.33
Accessories 14.2
NOT CALIBRATED 12.20
Daily 11.3 NOT INITIALIZED 12.20
Introduction 11.2 Notes 2.34
Log 11.25
Monthly 11.7 O
Semiannual 11.11
Unscheduled 11.13 O-rings
Weekly 11.6 Lubrication 11.9
Manual Box 1.15 Old Run
1.16 Load 4.37

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Phadia 100 - User Manual Index

Operation 2.32 PRESSURE TOO LOW 12.7

OUT OF RANGE 12.23 12.33
Primary Fuses 1.3
P Replacement 11.20
Specification 1.8
Password
Print
Change 1.24
All Samples 5.3
Set 1.24
Calibrators 6.8
Patient Report 10.10 Curve Control Log 6.3
Print 5.3 6.4
PC Remote 10.3 Laboratory Report 5.5
Lists 2.32
Pipette 1.2 5.11
Clean 12.27 Method 9.26
Tubing Connection 12.27 Patient Report 5.3
Volume 1.10 Quality Control Log 6.3
Pipette 1.2 Run Summary 5.12
Pipette Arm 1.2 Specific Run 5.5
PIPETTE PUMP MOTOR Specific Sample 5.4
CAN'T FIND FLAG 12.21 Printer 1.2
CAN'T POS FLAG 12.24
NOT CALIBRATED 12.20 Printer Paper
NOT INITIALIZED 12.20 Loading 11.19
OUT OF RANGE 12.23 Printout Error 12.62
PIPETTE R MOTOR Printouts 10.2
BENT PIPETTE 12.25
PROCEDURE 12.20
CAN'T FIND FLAG 12.21
CAN'T POS FLAG 12.24 Process
NOT CALIBRATED 12.20 Abort 4.44
NOT INITIALIZED 12.20 Duration 2.31
OUT OF RANGE 12.23 Processing Chamber 1.2
PIPETTE Z MOTOR Cleaning 11.4
BENT PIPETTE 12.25 Processing Error 12.14
CAN'T FIND FLAG 12.21 ERROR 12.16
CAN'T POS FLAG 12.24 FATAL 12.16
NOT CALIBRATED 12.20 WARN 12.16
NOT INITIALIZED 12.20
OUT OF RANGE 12.23
Processing Lid 1.2
Cleaning 11.4
Pooling 3.3
PROCESSING LID IS NOT
Ports 1.3 CLOSED 12.6
1.9 LOCKED 12.7
POWER TEMPORARY LOST 12.19
Q
Precautions 1.13
1.14 Quality Assurance 8.3
Predilution 3.9 Quality Club 8.11
Preparation Error 12.6 Quality Control
Prepared Run Add 4.20 15
Abort 4.39 Change with New Lot 4.35

12-3501-20/12 Page 15.7

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Index Phadia 100 - User Manual

Coefficient of variance Remove

Limit response 4.28 EliA Well 4.43
Edit 4.25 ImmunoCAP 4.43
Expected concentration 4.28
Repacking 13.2
Expected standard deviation 4.29
Handling 3.2 Replicate
Identity 4.26 Change 4.4
Instrument dilution factor 4.33 Request
Internal 8.4 Edit 4.2
Limit s 4.30
Log start date 4.32
Request Data
Lot number 4.32 Delete 4.40
Order 4.34 Request List 10.3
Predilution factor 4.33 RINSE BLANK IS TOO HIGH 12.13
Range maximum 4.31
12.50
Range minimum 4.31
Replicate 4.27 Rinse Blank voltage 12.54
Select 4.10 Rinse Solution 1.10
Set status 4.26
Specific IgE 8.6
Rinse Solution Bottle 1.2
Test name 4.27 1.6
Type 4.33 Cleaning 11.6
Quality Control Error 12.47 Rinse Tubings
Replacement 11.11
Quality Control-Log
Edit 6.5 Run Summary 10.16
Export 6.12 Print 5.12
Print 6.3
Printout 10.13 S
Quality Control 6.2 Sample Carousel 1.2
Quality Costs 8.16 1.4
Bottle Holders Replacement 11.21
R Cleaning 11.10
Installation 1.18
Re-evaluate 5.6 Tube Holders Replacement 11.22
Reagent 3.2 Sample Carousel Cover 1.2
Contamination 3.2 SAMPLE CAROUSEL COVER
Pooling 3.3
IS NOT PRESENT 12.6
Temperature 3.2
SAMPLE CAROUSEL MOTOR
REAGENT BLANK IS TOO HIGH 12.11
BENT PIPETTE 12.26
12.49 CAN'T BE POS 12.33
Disable 5.9 CAN'T FIND FLAG 12.22
Reagent Handling CAN'T POS FLAG 12.25
EliA IgA 3.4 NOT CALIBRATED 12.20
EliA IgG 3.4 NOT INITIALIZED 12.20
General 3.2 OUT OF RANGE 12.23
ImmunoCAP Specific IgA 3.4 Sample ID
ImmunoCAP Specific IgG 3.4 Change 4.5
ImmunoCAP Specific IgG4 3.4 Delete 4.7
Register SAMPLE TUBE EMPTY 12.31
Results from Quality Club 8.11

Page 15.8 12-3501-20/12

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Phadia 100 - User Manual Index

Sound Level 1.9 THE DIFFERENCE BETWEEN

REAGENT BLANK AND RINSE
Spacing Collars 1.15
BLANK IS TOO LOW 12.50
Spare Parts 14.2
Time 1.21
Specific Run
Training 1.12
Print 5.5
Training Mode 2.29
Specific Sample
Print 5.4 Tubes 3.7
Dead volumes 3.9
Specification
Specifications 3.8
EliA Well 1.12
Instrument 1.8
Solid Phase 1.12
U
Technical 1.8
Unpacking 1.15
SPURIOUS HARDWARE
Unscheduled Maintenance 11.13
INTERRUPT 12.18
USB ports 1.2
SPURIOUS NMI INTERRUPT 12.19
1.3
Start Up Error 12.3 1.5
Start Up Warning 12.3 1.9
Stop Solution
Handling 3.2 V
STOP SOLUTION VIAL EMPTY 12.32 VGA connector 1.3
Storage Conditions 1.9 Voltage Selector 1.3
System Rinse 11.24 Volume
Bottles 1.10
Pipette 1.10
15

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Index Phadia 100 - User Manual

W Washing Solution Bottle 1.2

1.6
Warm-Up Time 1.9 Cleaning 11.6
Warnings 2.34 Waste Bottle 1.2
Wash Rake 1.2 1.6
Cleaning 11.6
WASH RAKE MOTOR Emptying 11.4
CAN'T FIND FLAG 12.23
CAN'T POS FLAG 12.25 Waste Container 1.7
NOT CALIBRATED 12.20 Emptying 11.4
NOT INITIALIZED 12.20 Waste from Electrical and
OUT OF RANGE 12.23 Electronic Equipment 1.13
WASH/RINSE HAVE WEEKLY MAINTENANCE
BEEN MIXED 12.9 NOT PERFORMED 12.10
Wash Tubings Weekly Maintenance 11.6
Replacement 11.11
Weight 1.8
WASH/RINSE CHECK NOT OK 12.9
Workflow 2.32
Washing Solution 1.10
Accuracy 1.10
Working Conditions 1.9
Bottle 1.2
1.6

Page 15.10 12-3501-20/12

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Common questions

Correct setup and handling of the washing and rinse solutions in the Phadia 100 is crucial because improper preparation or contamination can lead to errors such as mixed or insufficient distribution of solutions, which affects the performance and results of diagnostic tests . Washing and rinse solutions must be prepared with purified water and according to specific guidelines to ensure accuracy and prevent cross-contamination . Precautions include ensuring proper bottle connections to avoid twisted tubings and preventing mixing of the solutions . Additionally, protective gloves should be worn as washing solutions may cause skin sensitivities . It's important to use the correct solution in the respective bottles and replace solutions regularly to avoid errors ."}

Neglecting maintenance on the Phadia 100 instrument can result in processing errors and assay result errors. These errors occur when maintenance procedures are not regularly performed, potentially leading to system malfunctions and inaccurate test results . Maintenance is structured to prevent these issues through a schedule that includes daily, weekly, monthly, and semiannual tasks. Daily maintenance involves procedures like rinsing to prevent blockages and cleaning parts that come into contact with human fluids to avoid contamination. Weekly maintenance extends this by cleaning all related bottles thoroughly to avoid carryover of contaminants . Monthly maintenance includes more detailed procedures such as lubrication of o-rings and cleaning the sample carousel, aimed at enhancing the overall functioning of Phadia 100 by preventing wear and ensuring smooth operations . Adhering to the maintenance schedule ensures the instrument operates efficiently and produces reliable results .

To ensure the accuracy and reliability of ImmunoCAP Specific IgE assay results, specific protocols must be followed. First, full calibration curves with specified IgE concentrations (0.35 to 100 kU IgE/l) should be performed in duplicates . For acceptance, each run must include ImmunoCAP Specific IgE controls tested for three allergens in duplicate and a negative control that should provide results below 0.35 kUA/l . The criteria for run acceptance include instrument software validation, mean control values within specified ranges, and pooled coefficients of variation (CV) within runs must be below 6%, with a total CV <10% for both controls and patient samples . Additionally, monitoring of specific allergens with continuous quality control using control charts and external quality assessment programs are recommended to assess accuracy . For internal control, results should fall within the calculated quality control ranges, and regular recalculations of mean and standard deviation are advised for consistent assay performance .

Maintaining accurate calibration in the Phadia 100 is crucial as it ensures the reliability and accuracy of the assay results. The calibration curve, which is established for each lot number, is stored and used in subsequent runs to verify assay performance. The validity of the stored calibration curve is confirmed if the curve controls are within specified limits, with the curve remaining valid for up to 28 days . During assay runs, the instrument automatically assesses whether the calibration curve and controls meet preprogrammed limits. If these checks are passed, the run can be accepted. If both curve controls are outside inner limits in the same direction or one control is out of the outer limit, results are not calculated and the curve is flagged . This process is essential not just for cost efficiency by reducing calibrator usage but also for ensuring assay consistency and accuracy over time . The decision to accept an assay run ultimately lies with the laboratory manager, who must consider other assay performance parameters .

The Action List is used to address assay-related errors on the Phadia 100, particularly insufficient sample volumes, by providing step-by-step corrective instructions. When an error such as a bent pipette is identified, the Action List advises users to check for sufficient volume in reagent vials, proper placement of ImmunoCAP/Wells on the carousel, and if applicable, the Sample Carousel Cover’s position . Additionally, similar instructions apply for errors like LOW RU, where users are advised to rerun samples if necessary and check for missed pipetting . The Action List helps to systematically troubleshoot errors, ensuring issues like air bubbles or inappropriate pipetting are resolved, which could contribute to sample inadequacy . It also warns not to empty the instrument before performing the actions, as this could hinder identifying the error's root cause ."}

Errors related to incorrect positioning in the ImmunoCAP carousel are typically resolved by first checking if the specific position on the carousel is affected. If an error persists after initial checks, contacting a Phadia representative is advised . You should ensure that the Sample Carousel Cover is correctly positioned and that all tubes and vials are properly shaped and filled according to guideline specifications . The Processing Errors and specific actions to resolve them are detailed in the Action List, which should be followed to correct any errors. Do not empty the instrument before performing the actions suggested, as this can hinder the identification of the error cause . Additionally, for mechanical errors such as obstructed carousel movement, visually check the processing chamber for loose ImmunoCAP or EliA Wells and reposition them if necessary .

Editing or removing a sample ID involves entering the Prepare Run mode, selecting Enter Request, and then accessing the Edit Request function. From there, the sample ID can be selected for editing or deletion using specified keys. Confirmations are necessary at multiple points to ensure the right sample is being adjusted or removed. These steps are crucial to prevent unintentional alteration of sample information, which could result in loss of test data, errors in assay results, or incorrect analysis of other samples within the carousel .

Phadia 100 handles and processes samples to prevent errors by using a systematic approach involving maintenance and reagent handling protocols. Before each assay, a Daily Rinse must be performed, and a Consumption list is used to verify sufficient volume of reagents, such as Washing Solution and Rinse Solution, is loaded correctly . The system ensures samples are loaded in the correct order and place within the Sample Carousel, guided by the software . Instrument dilutions proceed using specific tube specifications, avoiding double-bottom tubes to prevent pipette errors . Method compatibility is checked by the instrument, issuing warnings if incompatible methods like ElyA and ImmunoCAP are attempted simultaneously . This systematic approach, combined with operator guidance on dilution factors and sample handling, minimizes errors related to method compatibility and adherence to dilution specifications during assays .

Performing a daily rinse on the Phadia 100 is crucial to prevent blockages, microbial growth, and carry-over between assay runs. The process involves disconnecting the Washing Solution Bottle and replacing it with a beaker containing approximately 300 ml of purified water, then rinsing the system . This task should be done at the end of each day the machine has been used, ensuring that the Waste Bottle is emptied beforehand to avoid overflow . The daily rinse maintains the instrument’s performance and prevents errors, requiring about six minutes to complete. Neglecting this step may result in instrument performance issues and assay errors . Regular maintenance, including the daily rinse, thus secures the operational integrity of Phadia 100 ."

Criteria for acceptance of ImmunoCAP Specific IgE assay runs include completing three separate runs with specific conditions. For the first run, there must be a full calibration curve, ImmunoCAP Specific IgE Control tested for three allergens in duplicate, a negative control tested with the same allergens, and at least six individual patient samples also in duplicate. Acceptance criteria for this run require the software to accept the calibration curve, the mean values for the control to be within the given range, and negative controls to be negative . In Runs 2 and 3, single replicate curve controls are used alongside the same control and negative control protocols as Run 1, with acceptance requiring curve controls to be within range and the runs accepted by the software . Total acceptance of the assay results requires fulfilling the criteria for all three runs, pooled coefficients of variation (CV) within runs of less than 6% for controls and patient samples, and a total CV of less than 10% . Once these criteria are met, clinical results can be deemed valid for reporting ."}

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