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OPERATOR’S MANUAL
1.1 Applications
1.1.1 Intended Use
The LuMatic™ Model 4401 CLIA Microplate Reader is a laboratory instrument
intended for in-vitro diagnostic use. It is a user-programmable open system with
selectable plate formatting, alphanumeric test naming, automatic interpretation
options, duplicate well options, curve plotting and editing, and flags and error
messages.
The LuMatic™ Model 4401 CLIA Microplate Reader offers all the benefits of
CLIA technology: sensitivity, speed, and dynamic range. With LuMatic™ and
AccuLite®, Monobind gives you an open-system CLIA platform with a 45+ test
menu. Raw data RLU readings and calculation modes such as single point
calibration, point-to-point curve fit, multipoints, polynomial regression, linear
regression (log & linear), cubic spline and cutoff modes are offered. The basic
calculations are permanently stored in memory and include several single and
multi-point equations. Each calculation mode is described in detail in Section
4.2-Assay Modes. Provisions are made in certain cases for reading specimens
in duplicate and/or using the mean reading in calculations.
The LuMatic™ Model 4401 CLIA Microplate Reader reads a 96-well microplate
and calculates results instantly and automatically; and it accepts all standard
microplates. Trays containing microstrips may also be read. The robustness of
AccuLite® allows for two-point calibration enabling laboratories to run more
patient samples per plate, reducing reagent use and overall test cost. LuMatic™
and AccuLite® offer a convenient and affordable package designed to bring high
quality immunoassays to markets worldwide.
The LuMatic™ Model 4401 CLIA Microplate Reader uses the power and
efficiency of your PC to deliver sophisticated data analysis, curve fitting, reporting
and data storage. It is based on the same software as Monobind’s Autoplex™
Analyzer, and may be used together with a single interface. Simply connect via
USB and load the LuMatic™ software containing the device manager and
AccuLite test data. Then select desired assay(s) and start running AccuLite®
CLIA right away.
FUSE: For continued protection against risk of fire, replace fuse only with one of
the specified type and current ratings. Disconnect equipment from power supply
before replacing fuse.
FUSIBLE: Pour la protection continue contre le risque du feu, remplacez le
fusible seulement par une du type spécifique et des estimations courantes.
Démontez l’équipement de l’alimentation d’énergie avant de remplacer le fusible.
• Servicing There are no user-serviceable parts inside the instrument. Refer servicing
to qualified service personnel. Use only factory-authorized parts. Failure to do so
may void the warranty.
• Wear Protective Apparel Many diagnostic assays utilize materials that are potential
biohazards. Always wear protective apparel and eye protection while using this
instrument.
• Follow Operating Instructions Do not use this instrument in a manner not specified
by the manual, or the protection provided by the instrument may be impaired.
• Use Proper Power Cord Use only the power cord specified for this product and
certified for the country of use.
• Ground the Product This product is grounded through the grounding conductor of
the power cord. To avoid electric shock, the grounding conductor must be connected
to earth ground. An optional method is to attach a ground strap from the external
grounding terminal on the rear panel of the instrument to a suitable ground such as a
grounded pipe or some metal surface to earth ground.
Warning!
Avertissement!
Warning! To avoid electric shock, the grounding conductor in
the supply cord must be connected to earth ground. An
optional method is to attach a ground strap from the external
grounding terminal on the rear panel of the instrument to a
suitable ground such as a grounded pipe or some metal
surface to earth ground.
• Do Not Operate Without Protective Covers Do not operate this instrument with
covers and panels removed.
• Use Proper Fuse Use only the fuse type and rating specified by the manufacturer for
this instrument.
• Avoid Exposed Circuitry Do not touch exposed connections and components when
power is present.
• Do Not Operate With Suspected Failures If you suspect there is damage to this
instrument, have it inspected by a qualified service person.
• Keep Instrument Surfaces Clean and Dry Solvents such as acetone or thinner will
damage the instrument. Do not use solvents to clean the unit. Avoid abrasive
cleaners. Clean the exterior of the instrument with a soft cloth using plain water. If
needed, a mild all-purpose or nonabrasive cleaner may be used. Use as a
disinfectant a 10% solution of chlorine bleach (5.25% Sodium Hypochlorite) or 70%
isopropyl alcohol. Take special care not to spill liquid inside the instrument.
• Avoid lifting, leaning or turning the instrument over when a plate is in place.
• Be sure to run a sufficient number of controls in each assay. If controls are not within
their acceptable limits; or if incomplete, disregard test results.
Biohazard Precautions
Warning!
Avertissement!
WARNING: If any materials are overturned during operation,
immediately set the power switch to OFF (0). This material should
be treated as potentially biohazardous. Appropriate cleanup and
disposal of biohazardous waste should be used.
• Physical
Enclosure: All metal enclosure
Dimensions: 7.5” x 8.0” x 16.5”
(19x20.3x42cm)
Weight: 12.5 lbs (5.7 kg)
• Environmental
◦
Operating Temperature: 15 to 35 C
Humidity: Between 10 and 85% non-condensing
◦
Storage Temperature: 10 to 50 C
Altitude: 2000m maximum
NOTE: Retain the original packing material for future use in the event that the
instrument is shipped to another location or returned for service.
Unpacking Checklist
Quantity Description
1 Customer copy of packing list
1 Unpacking instructions sheet
1 Certificate of Conformity
1 Certificate of Quality
1 Instrument Set Up and Operator’s Manual
1 Power cord
1 USB cable
1 USB mass storage device
For 220-240 V units used inside the US use a UL listed cord as above, except rated
250 V, with a tandem blade, grounding type attachment plug. The cord set provided
by the manufacturer meets these requirements.
the IEC 417 symbol 5019 . DO NOT loosen or remove these fasteners or
connections. An alternate method of grounding is provided by connecting the
grounding terminal located on the rear panel, to a suitable ground.
To avoid electric shock, the power cord protection ground conductor must be
connected to ground.
Fuse Requirements
The fuses are located internally in the instrument; there are two fuses. Fuse number
1 is located on the main printed circuit board near power connector J4. It is a 4 Amp,
medium acting, 250V, 5 x 20mm, Littlefuse type 0234004 or equivalent. Fuse number
2 is located on the power supply. It is a 2.5 Amp, fast acting, 250V, 5 x 20mm,
Littlefuse type 21602.5P or equivalent.
Fuse failure is a very rare occurrence and may indicate malfunction of the equipment
requiring service by qualified personnel.
Warning!
Avertissement!
FUSE Warning! For continued protection against risk of fire, use
the correct fuse. Disconnect power cord from mains supply
before replacing fuses.
A) Door
B) Indicator
A
B light
A) Tray out
(extended)
B) Indicator
light
C) Door open
A
B
B) Power cord
connection C) USB
Connection
A
B C
AS WITH MANY USB DEVICES IT IS CRITICAL THAT YOU DO NOT CONNECT THE
USB CABLE TO THE LUMATIC™ OR COMPUTER UNTIL THE SOFTWARE HAS
BEEN INSTALLED. DOING SO MAY AFFECT THE INSTALLATION OF THE
APPLICABLE DRIVERS NEEDED TO RUN LUMATIC™ MANAGER.
Follow the steps in Section 3.3.1 Software Installation and then reference Section 3.3.2
for USB port connectivity.
Double-click on
setup.exe to begin
Setup
And then the opportunity to select the destination folder default or choose another folder:
LuMatic™ Manager
Icon
The LuMatic™ COM port setting does not require an adjustment to match the
computer’s COM Port setting. However, steps have been provided in Section 6.2.2
LuMatic™ Communication (COM) Port Setting to view/adjust the setting if
necessary.
USB cable
NOTE: If it is necessary to view / adjust the communication port settings of the computer
and the LuMatic™ instrument refer to the instructions found under Section 6.2 - COM
Port Settings.
When the LuMatic™ instrument powers up, note the following actions:
The instrument will perform an initialization process and annunciate three short
beeping sounds signaling it is operational
If the instrument powers up, but the actions described above do not occur, check the
USB cable connections and COM port settings.
Review the following questions before beginning a test (refer to the CLIA kit insert for
required information):
NOTE: For the purpose of this manual, the terms calibrator and standard are
used interchangeably to designate reference materials of known
concentrations
NOTE: For the purpose of this manual, the terms specimen and sample are
used interchangeably to mean materials of unknown concentrations.
8. Will a cutoff value be used to label positive samples? If so, the value which
begins the positive range will be required.
Access the Assay Modes via LuMatic™ Manager Tests Menu (refer to Section
5.2.2)
RLU
Factor
Standard
% RLU
Point to Point
Linear Regression
Dose Response
Cubic Spline
Cut Off
Blanking is optional.
8. “Y=Log(1000*RLU), X=Log(Conc)” --
the base-10 log is plotted against the
base-10 log of the concentration.
Y = Bottom + (Top-Bottom) / (1 +
10 ^ ((LogEC50-X) * HillSlope))
yielding a sigmoid curve.
Blanking is optional.
¾ COV = X * mean (Nc) + F
• For interpretation, you may chose either the Regular Cut Off Mode
(positive >= cutoff, negative < cutoff), or the Reverse Cut Off Mode.
With the Reverse Cut Off option, the Samples with values lower than
the cut off are labeled as “positive”. If you choose this option, be
careful to follow the < and > signs in the prompts for entering cut offs
and ranges.
• mCC = the calculated mean of the RLU values of the cutoff controls
when test is run
The user may choose either the regular cutoff mode (positive >= cutoff,
negative < cutoff), or the reverse cutoff mode (positive <= cutoff,
negative > cutoff). The instrument calculates the mean of the positives
and the mean of the negatives.
Figure 1 shows a standard curve (with calibrators labeled A-G) being used to
ascertain the concentration of TSH in unknown specimens:
F
E
D
C
B
A
Note: Due to the inherent variability in light and CLIA testing, Monobind does not
recommend the use of stored curves alone.
Choose 2Pt Calibration from the Add calibration test drop down menu (A)
Click on the Add to Plate button (B), and then add the samples to the plate (refer to
Add Samples to Tab section for more information).
After the run completes, the screen will display the curve (C) and the RLU data of the
two adjustment points. The samples run with the 2 point adjustment will have their
read RLU values adjusted based on the RLU values of the two adjustment points.
Values
of two
adjust-
ment
points
Admin
Admin
1 2 3 4 5
1 Connect
3 Lot # Registration
4 QC Tracking
5 Sample Database
OPTION DESCRIPTION
Connect Establishes or re-establishes communication between LuMatic™
software on the PC to the instrument.
Communication Opens the interactive Communication Window used for certain
Window diagnostics. Should only be used by trained service personnel.
LIS Import See Laboratory Information System (LIS) section in the Appendix for
information explaining the LIS Import Option and examples of import
and export files.
New Assay Displays current assay calibration list.
Calibration Data
Exit Click Exit to close the program and a dialog window will display:
OPTION DESCRIPTION
Use Blank Click on the check box if Blank is used.
Read Plate Click on the Read Plate button to activate.
Last Read Well If an end of read location is desired, indicate well and
row, such as F12. Otherwise, the entire plate is read.
(Empty=Read All)
Export Click on the Export button to send the RLU readings to
Notepad, creating a .txt file:
A B
OPTIONS DESCRIPTION
Assay Name Enter the name of the assay (A)
Select an Assay Select an Assay Mode from the drop down window
Mode (B)
Select Blanks: Click on the Properties button to enter the RLU range, select
the action to take when result is out of range from the dropdown menu
(choices are Issue Warning or Invalidate Tests), enter a minimum number to
use, and then press the OK button.
Select Controls: The controls will be accepted even if they read out of range
if the Control Properties are set to “Issue Warning”. To check your Control
Properties or change this setting, see the Assay Calibration Tab. Click on the
Interpretation button (F).
Specify range by clicking the Normal/Linear Range button (G) to monitor the
quality (optional). Highlight the field to change, type in new value.
J K I
Use Print Preview (J) to view, and Print (K) to obtain a printout of the assay
created.
Select the Assay from the drop down menu. Dialog window will open with
options based on the assay type.
STEPS DESCRIPTION
1 Click on Lot # Registration from the Management Menu.
2 Identify the Substance to be registered by clicking on the
substance title from the dropdown menu.
3 Click “Register”
4 Enter the lot number and a description (optional). Click OK to
Save.
When first opened, the Sample Database window will not have any records to
display:
Click on
the Edit
button to
enter data.
The Edit
button will
toggle to
Done.
Click on
the Done
button
when
finished
entering
data.
Navigate through the fields on the screen by using the Tab or arrow keys
on the keyboard.
Modify the information and then press the Done button to save the changes.
The log will display the modification date, time and the change that was made:
1) Click to highlight the Sample ID to import. Select the Import button to migrate
the selected record to a text file in Notepad.
1) Click to highlight the Sample ID to export. Select the Export button to send the
selected record to the Patient DB.log in Notepad.
2) Click on File and select Save. Close the window when finished.
1) Enter criteria into Search Database area, press OK. All records containing the specified
criteria will display.
Search
result
displayed
1) Select the Choose button to add a selected patient to the Sample ID list in the Sample tab.
Refer to the Sample Report that follows for an example of the custom reports that
may be generated.
OPTION DESCRIPTION
Comm Port, Database, Refer to the steps in Section 6.2 COM Port Settings to
Report…: view / adjust the COM Port Setting of the computer and
the LuMatic™ Model 4401 CLIA Microplate Reader.
5.2.6.1.1.1 Start up
OPTION DESCRIPTION
Startup Allows the user to adjust settings such that numerical ID
and sample ID records will be retained for a specified
amount of time; and adjust the COM Port setting to
match the COM Port setting of the computer.
Sample Database Allows the user to customize the field names used in the
sample database. Click on the checkbox to uncheck the
selection; only selections that are checked boxes will be
applied. Click the OK button once all the selections have
been made.
OPTION DESCRIPTION
Report Output Report Output allows the user to specify data to print for
different report types.
OPTION DESCRIPTION
Custom Report… The Custom Report Template screen allows users to
choose a report template for each type of report they
Two types of Custom desire to run.
Report Templates are
available: Choose the type of report to run and click on the Set
Template button. The report will be formatted according to
the chosen template until the Custom Report template has
been cleared by clicking on the Clear button.
A) Result report
templates which are
for custom reports that
have been sorted by
request time, sorted by
name/ID, or sorted by
assay.
B) Assay specific
calibration templates
allow the user to
produce a report from
the data of a specific
assay.
Custom Report…
Click on the Set Template
button to select a Custom
Report template. Preview
calibration reports via the
Calibration Tab and
preview button; preview
sample reports via the
Report Tab and preview
button. Modify the
example Custom Report
and save it to a new file
name.
A list of the available language choices will display. After selecting a language, it
will be necessary to close the Manager and restart the software to initialize the
selected language.
The selected language will remain in effect until another language is selected
and the software is restarted as in the step above.
Once the correct password is entered the Firmware Update window will open
enabling the user to browse the list of files. Technical support will advise which
file to select. The progress of the update is displayed in the Update Progress
field.
NOTE: The instrument will reboot itself after the firmware update is complete.
With ‘Enabled’ checked, the security system is ON. Only Administrators have
access to this option.
Login as Different User displays the Login screen and allows user to login
with a different name and password.
Logout logs current user out of the system, prompts user first:
Create New User creates a new user with ID, password, and security level.
The Administrator and Manager(s) may create users.
Change Password All security levels may use this feature. Enter the old
password followed by the new password, and confirm new password.
1 2 3 4 5
The list above is the order in which the tabs appear on the menu. In practice, the
order the tabs will be used / repeated are:
Test Results
Report Tab
5
4
6
3 8
7
This window displays the current status of the instrument. Also shown is the currently
loaded plate.
Feature: Description: Item No.:
Auto Assign Auto Assign allows the user to select 8-way or 12- 1
way trays. This setting will remain in force until
changed.
Tray In / Tray In / Tray Out buttons are provided to allow 2
Tray Out the user to manipulate the instrument door to the
Open or Closed position.
Load Plate / Load Plate sets up a previously stored assay and 3
Save Plate Save Plate allows saving a set up assay for future
use.
Plate Location of 96 wells 4
Well Displays area for the position of blanks, the 5
Assignment standard, blank, control(s), Sample ID, and name
of the Assay.
2
1 8
6
4 5 7
Selections –
• Select the Curve option to run a new curve, inserts
a blank and a calibrator for the assay into the work
list. Select multiple times to add more copies of
each. This button is not active if the user is running
an assay that does not require calibrators.
• The 2PT Calibration option is available in Point to
Point (Monobind AccuLite® tests) and Regression
modes and may be used to adjust stored
calibration curves. Once a calibration curve is run
for an assay the user can run a 2-point calibration
which will run the second and the next to the last
calibrators of the calibration curve. The RLUs of
these calibrators will be compared to their values in
the stored calibration curve. The sample
concentration values of the samples run with the 2-
point calibration will be calculated based on the
degree of luminescence change detected in the
stored values of these two calibrators. This allows
the software to compensate for any run-to-run
variability in the assay calibration without having to
rerun the complete calibration curve. Reference
Section 4.2.1 Two Point (2PT) Calibration for more
information.
• Select the Control option to add all of the Controls
specified in the assay. Press the button multiple
times to add multiple copies of the controls.
• NOTE: The user may also select calibrators,
controls, and blanks individually.
Calibration/Controls View the calibration and control results in this area. 3
List Lists the calibrators and controls by name, copies
required, and whether or not they are valid.
Select Curve from the drop-down menu. Press the New Curve button once for each
blank and calibrator you intend to run. Select Controls to add controls.
Press Add to Plate (3); the Plate Layout tab will open. Once the correct sample
layout is confirmed, click on the Read plate button to read the plate.
A new assay with a correct valid curve is automatically accepted. The option to
change the curve is available. If the curve is invalid, it will need to be selected and
then accepted before it can be used to calculate sample concentrations. Click on the
Accept button to accept results.
When LuMatic™ is finished reading, the New Assay Calibration Data may be viewed
by selecting this option from the Management drop down menu or by pressing the F8
key on your keyboard at any time. This window shows whether the new curves and
controls were accepted. If the curve is not accepted, this procedure must be
repeated.
Once the calibrators have been moved into the Assay Calibration Tab they need to
be accepted. However, selecting the calibration does not make the calibration graph
visible. Select the assay from the drop down list and then click on the graph icon (1)
and the calibration curve will display on the right hand side of the screen (2).
The stored curve which is active is displayed on the bottom of the screen. This may
be the previously stored curve or a newly accepted curve. Before the curve is
accepted it can be reviewed for any adverse outlying calibrators. If the outlying
values are seen for any of the calibrators, these may be removed by unchecking the
check box next to this calibrator.
The resulting calibration curve is shown in the upper graph. Once you are satisfied
with the calibration curve in the upper graph, click the Accept Selected button and
this will move the curve from the upper graph to the lower current graph.
In Figure 5.3.2-3, a standard curve is displayed. This assay uses a 2nd order
polynomial curve fit. Moving the mouse pointer over the plotted curve will display the
fit parameters.
At this point concentration values will be calculated for the samples and displayed in
the Test List Tab.
The samples can now be accepted by clicking on the Accept button. The sample
results will be moved from the Test Results Tab to the Report Tab where they are
automatically stored in the LuMatic™ database and may be printed in reports.
Clicking on the Test Results tab will display the patient results.
The new concentration values are displayed in the Add Samples Tab.
The percent adjust feature may be used when stored curves are used and there
is evidence that the current run has resulted in increased or decreased RLU
levels than what is expected.
Less than all of the calibrators used in an assay can be run and the stored curve
can be adjusted accordingly. The adjustment factor will be calculated based on
the average percent change of all the new calibrators run compared to their
stored RLU values. The new curve will be generated from the new calibrator(s)
RLU values which are currently run and the adjusted values of the remaining
calibrators from the stored curve. This feature can be used to control for
changes in activity when using stored curves.
By selecting this standard and all the stored standards the new adjusted curve
can be activated.
Once accepted the original RLU values remain, but the new calculated
concentration values of the standards are displayed.
Even though the samples show decreased RLU values similar to the one
adjustment standard run, the resulting concentration values for the samples are
the same as when they were run with the original complete standard curve.
The LuMatic™ software will force a standard curve to be run with Samples if a
stored curve does not exist. If a valid stored curve exists, the user will have the
choice of running a new curve or performing a 2-point adjustment from the stored
curve.
The LuMatic™ software will allow a user to use a stored curve without
performing a 2-point adjustment if the user’s security level is at Manager or
Administrator level. With the proper security level enabled, the software will
display the following dialog box when the Read Plate button is pressed and
Samples are added to the plate without any calibrators.
If the user is logged in with an Operator security level and no standard curve or
2-point adjustment is added with the Samples when the Read Plate button is
pressed, the following Login dialog box will display allowing a Manager or the
Administrator to log in.
1 2
If the Add to Plate button has been selected, the screen will be directed to Plate
Layout where you will have several options: Load Plate, Save Plate, Reset, Re-
Assign, Read Plate or Remove.
3
4
1 2
6 7
8 9 10
4 5
Note: If needed, an Assay Report or a Calibration Report may be printed from the
Calibration window. See the Section Assay Calibration Tab for more information.
Print Select the Print Preview button, the report will display 6
Preview providing an advanced glance of what the output will look
like:
Print Selecting the Print button will print the selected Results in 7
report format.
Remove Selecting the Remove button will remove all selected 8
items from the results display.
Retest Adds the selected items to the Sample Tab to be re- 9
(add to tested.
Sample
Tab)
Export Exports selected results to a text file (*.txt), MS Excel file 10
(*.xls), or XML file (*.xml). Save for future reference.
003 Invalid Row Number, Row number must be in valid range (1-12)
%d
004 Invalid Device Number, Device number must be in valid range (0-3), contact
%d Customer Service
005 Invalid wiper value, %d Wiper number must be in valid range (0-3), contact
Customer Service
006 Invalid Cal Value, %d Value must be in valid range (20-110), contact
Customer Service
007 Invalid Offset Value, %d Offset value must be in valid range (5-250) contact
Customer Service
008 Invalid Gain Value, %d Gain value must be in valid range (5-250) contact
Customer Service
411 Offset search error Background error. Record the difference between the
Read Value and the Target Value. If Read Value is 0
then there is a fault in the light conversion and read
circuits. If Read Value is higher than the target value
then the likely cause is lack of warm-up time or light
leakage into the PMT mounting block. (If the unit has
been dismantled in any way, then check that
everything has been correctly re-assembled.)
Possible faults:
Read Value > Target Value
• The unit has not been allowed to fully warm up.
• Door is not fully closed.
• Main cover is not fitting correctly. Check screws
and fit.
• High voltage Cover has not been fitted.
• Sealant around the fiber optic to PMT interface
has been disturbed.
• Sealant around the PMT to block has been
disturbed.
• Fiber is not seated properly at both ends.
• The PMT reference LED does not switch off and
gives the same reading for ON Value as OFF
Value using the "RDREF()" command. See fault
finding procedure for Error "503 Reference
adjustment out of range".
Read Value = 0
• Cable connections may not be correctly seated.
(It is important that all connections are exactly
correct both destination and orientation). If any
cable has been plugged into the wrong socket
and the machine has been powered on, some
circuits may have been damaged which will show
as multiple faults.
• High Voltage board may not be working (see LED
lamp on board).
Power on the LuMatic™ The computer screen will display the LuMatic™ logo:
Model 4401 CLIA
Microplate Reader. The
instrument will
annunciate a beeping
sound; the LED power
indicator will light (the
light will pulse/flash);
and the instrument will
warm-up. When the
instrument has
completed its
initialization process, it
will annunciate three
short beeping sounds
signaling it is
operational.
Click on the
Communication Port
drop down menu, and
scroll up or down to
locate the COM port
setting that matches
the COM port setting
from your PC (see
Section 6.2.1 PC
Communication
(COM) Port Setting).
Message Header
H|
Append to the Previous Record
A|
Patient Segment
P| Transmission Seq#| Patient-ID | | | Patient Name | | | Sex| | Address| | | Doctor
Observation Order Segment
Assay
OBR| Sequence Number| | | Name
Nature of
Observation Reference Abnormal abnormal
OBX| Sequence Number| Value Type| | Value | Units | Range | Flags | | checking
Message Terminator
Patient
L| Sequence Number| | Count | Line Count | Batch Number
NOTE: A solid bar (|) indicates the field is for future use. The bar delimiter is
necessary for correct formatting within the record.