Trouble Shooting Elecsys2 010v53

r
Troubleshooting Guide
Elecsys® 2010
cobas e 411
Version 5.3
Troubleshooting Elecsys® Systems Page 2 of 142
Table of Contents
1. TROUBLE SHOOTING GUIDE ELECSYS® SYSTEMS: QUICK INFO 4
2. ELECSYS® 2010 TROUBLESHOOTING PROPOSAL 6

2.1 Complaints concerning individual false measurements 6
2.2 Complaints concerning drift 7
2.3 Complaints concerning assay calibration 8
2.4 Complaints concerning recovery of controls 12
2.5 Complaints concerning intra assay precision 13
2.6 Complaints concerning inter assay precision 14
2.7 Complaints concerning method comparison 15
2.8 Complaints concerning system to system variance 16
3. SUPPORT LISTS 17
®
3.1 Expected counts for calibration of all Elecsys 2010 assays 17
3.2 Assay Summary Elecsys® 2010: LDL, measuring range, stability, CV, etc. 22
3.3 Elecsys® Universal Diluent or MultiAssay (MA) Recommendations 87
3.4 Checklist of reagent handling 95
3.5 List of sample container dead volumes 98
3.6 Sensitivity of assays to systems malfunctions and system phenomena 99
3.7 Foam on calibrators / samples / reagents 102
4. ELECSYS® 2010: OVERVIEW LOT AND RACKPACK CALIBRATION 103
5. ELECSYS® 2010 ASSAY CALIBRATION 104

5.1 Lot calibration, reagent pack calibration 104
5.2 Calibration validation criteria 104
5.3 Calibration stability (please check the package insert) 105
5.4 Calibrator Concept 105
5.5 Calibration procedure when > one Reagent pack for one assay on board 106
5.6 Examples of control of calibration in Elecsys® 2010 software version 03-08/12 (not avail.
in 06-x or cobas e 411) 113
5.7 Main differences concerning assay calibration between different Elecsys® 2010 software
versions 114
5.8 Calibration factor 116
5.9 Recommended assay calibration after a service action 117
6. CONTROL TARGET VALUE (FIRST) ASSIGNMENT 118
7. ELECSYS® DATA CONCEPT 120
8. SOFTWARE INFORMATION 122

9. MARKETING NEWS: THROUGHPUT OF ELECSYS® 2010 123
10. ELECSYS® 2010 MEASURING PRINCIPLE 129
11. TECHNICAL INFORMATION/FLOW CHARTS 131

11.1 Run preparation 131
11.2 Resume 134
11.3 Finalization 135
11.4 LFC 136
11.5 LLD Pipettor 137
11.6 LLD Sipper 138
11.7 Liquid Flow Tubings 139
b-TroubleshootingElecsys2010v53.doc-SC
12. FREQUENTLY ASKED QUESTIONS 140
CHANGES IN THE DIFFERENT VERSIONS:
2.8 Updates of chapter 3.1/3.2/ 3.5/ 3.6/5.5/5.6/5./8/12

2.9 Updates of chapter 3.1/3.2/3.3
3.1 Updates of chapter 1/5.5/5.7
3.4 Updates of chapter 3.1/3.2
3.8 Updates of chapter 8
3.9 Updates of chapter 3.1/3.2
4.1 Updates of chapter 3.1/3.2/3.3/8/12
4.3 Updates of chapter 3.1/3.2/3.3/3.6/5.7/6
4.5 Updates of chapter 1/3.1/3.2/3.3/3.4/5.5/12
4.6 Updates of chapter 2/3.1/3.2/3.3
4.7 Updates of chapter 2.1/3.1/3.2/3.3/5.5
4.8 Updates of chapter 2.1/3.1/3.2/3.3/3.6/7
4.9 Updates of chapter 2.1/3.1/3.2/3.3
5.2 Updates of chapter 3.1/3.2/3.3/3.5/3.6
5.3 Updates of chapter 1/2.1/3.1/3.2/3.3/3.5/3.6
All lists for Elecsys® 2010 are also valid for cobas e 411, when there is no further comment that it
is not valid.
1. TROUBLE SHOOTING GUIDE ELECSYS® SYSTEMS: QUICK INFO
Information needed in case of an Elecsys® customer complaint
In most cases, it is not easy to identify whether the
 “reagent handling”
 instrument
 reagent kit / calibrator / control
is the reason for the customer complaint.
Therefore, it is necessary to get as much information as possible, e.g. as described

below.
• A clear description of the problem/phenomena/case:
 Problem observed with all or just one assay?
 Problem observed with all systems or with one system?
 Problem observed with all or just one serum?
 When did the problem start e.g. after reagent lot change?
• All case-related reagent lots
 reagent kit, calibrators, controls, ProCell, CleanCell, disposables, SysWash

in use or not
• All case-related results
 patients incl. patient history, QC, calibrators, calibrator signal level
• Details concerning "reagent handling"
 calibration frequency, control handling, etc.
• Type of instrument, software version ect.
Within Grips under Document Type “Assay Summary” there is the HETIA complaint
check list available.
In the case of recovery or precision problems, we recommend analyzing the

error profile as follows:
1. Check the “reagent handling” at customer site

(detailed check list is in Grips in document type assay summary)
 try to obtain as much information as possible regarding
 customer "reagent handling“
 used reagent, calibrator, control lot
 calibration signals
 control results
 compare this information
 with expected results
 with results from other labs in e-LabPerformance.
If there are control recovery shifts after reagent lot change:
 Please check our internal measured control recoveries (in Grips in document
type assay summary). Internal control value assignment may be reason of
control shift.
 Possibly manually entered values are used at customer site.
Our experience shows, that in most cases, ”reagent handling” or ”control
value assignment” is the cause of the problem.
2) Check the instrument

 artificial media test
 mechanical adjustments - pipettor/sipper LLD
 microbead mixer shape and speed ect.
 Chapter 3.5 of the TSG summarises the known sensitive assays reacting to
different system malfunctions.
3) If neither of these points are the reason, the
 reagent kit
 calibrator
 control
is probably the cause of the trouble.
We recommend sending the used "reagents" together with as much
information as possible to GCS Penzberg. A CAPA (corrective and preventive
action) is initiated in case of a confirmed complaint.
Please note that within the Troubleshooting Guide Elecsys® 2010 there is much more
detailed information concerning troubleshooting as well as support lists, technical service
instructions etc. We have summarized experiences that from both internal and external
sources - from different countries - to share them with all those concerned.
We would very much appreciate it if we could add your experiences to the Troubleshooting
Guides for Elecsys® Systems.
Claudia Schäfer, Global Customer Support August 2010
2. ELECSYS® 2010 TROUBLESHOOTING PROPOSAL

2.1 Complaints concerning Possible causes Actions/Prevention
individual false measurements
False low or false high results • Foam on ProCell/CleanCell. • Have you handled the reagents, samples and
• Foam on assay reagents and/or samples and/or controls according to the package insert?
controls. Have you carefully refilled the water container
• Sample container used which have not been (not to cold degassed water).
recommended (outside diameter < 13 mm). • Have you performed recommended
• Cup adapter not used for sample container with maintenance?
outside diameter of 13 mm. • Call service (check adjustments, change
• PreAnalytics (splashes from another sample, mix up water filter, carry out APC tests, carry out
of sample cups, hemolysis e.g. in Folate samples, service maintenance?).
incomplete clotting of sample)
• Storage conditions of sample material not considered
(see package insert).
• Airbubbles in the distilled water container when
refilling the container with distilled or deionized water.
• Dirty Gripper (deposits contaminate the reaction
mixture in the AssayCup).
• Dirty sample probe
• SysWash not used or not adequately prepared
• Unstable system table.
• Insufficient EMI compliance in the lab
• Hardware failure
* Broken wires of mixer motor.
* Mixer not within specification (speed, shape)
* Sipper probe clotted.
* Restricted sipper path
* Reference electrode defective (flag 42).
* Tubings or seals not tight.
* Foam on microbead bottle dependent on bent axis
of microbead mixer motor.
* damaged pinch tubings
* Tighten torque / alignment problem of tubings
attached to measuring cell
b-TroubleshootingElecsys2010v53.doc
2.2 Complaints concerning drift Possible causes Actions/Prevention

Control or sample shows drift over time • Evaporation of system reagents • Have you handled the reagents, samples
(ProCell/CleanCell). and controls according to the package
• Evaporation or incorrect storage conditions insert?
of reagent kits. • Have you performed recommended
• Reagent kits are not at proper temperature. maintenance?
• Recommended calibration frequency not • Call service (Check lifetime of MC, carry out
followed (see point 6 assay calibration). APC tests).
• Recommended handling of controls and
samples not followed.
* Measuring cell (MC) defective (lifetime1
year or 50000 cycles warrantee depending
what occur first).
* Measuring cell (MC), Photomuliplier (PMT),
incubator or system reagent temperature
not within specifications.
* Photomultiplier (PMT) defective.

assay calibration
A. Calibration cannot be carried • Reagent kit or Calibrator not on board. • Check bar code of calibrator vial,
out • Calibrator expiry date exceeded. calibrator bar-code card, reagent kit (bar
• Calibrator vial bar code, Calibrator lot specific bar-code card code damaged?, correct position of the
not read or wrong calibrator bar code card is used. bar code?)
• Data link not available for combination reagent kit and • Wipe of the dust on the surface of the
CalSet, when e.g. mix of 1st and 2nd generation assay. bar-code reader.
• Empty space or sample positioned between CalSet 1 and • Wipe the calibrator vial when it is wet.
CalSet 2. • Check calibrator position.
• CalSet 1 and CalSet 2 not on same rack (E2010 rack • Change sample rotor with too much
version). play.
• Not recommended old work disk used, with old reference • Call service (check bar-code reader
table (assay not on reference table). adjustment?).
* Bar-code reader adjustments not ok.
B. Calibration not released • Foam on calibrator or assay or system reagents. • Have you handled the reagents and
• Reagent kits stored not at proper temperature (≤ 0°C). calibrators according to the package
Duplicates out of limits • Too less calibrator volume. insert?
• Air bubbles in the distilled water container when refilling the • Careful refilling of the water container
container with distilled or deionized water. (not to cold degassed water).
• Hardware failure. • Carry out a new assay calibration (new
* Pinch tubes defective (not exchanged after two months) CalSet necessary?).
* Microbead mixing speed out of specification. • Have you performed recommended
* Microbead mixer shape bent. maintenance?
* Clogged distilled water filter (MD6). • Call service (check adjustments, check
* Tubings or seals not tight. bead mixer, check LFS?).
C. Calibration not released • Reconstituted calibrator not transferred to the correct bar- • Have you handled the calibrators
coded calibrator vials. according to the package insert?
Monotony not fulfilled • Carry out a new assay calibration (new
CalSet necessary?).

assay calibration
D. Calibration not released • Foam on calibrator, assay or system reagents. • Have you handled the reagents and
• Empty calibrator, when e.g. lyo calibrator not reconstituted. calibrators according to the pack.
Missing values • Too less calibrator volume in the CalSet vial. insert?
• Hardware failure • Carry out a new assay calibration (new
* Gripper adjustment not ok. CalSet necessary?).
• Call service (gripper failure, carry out
APC tests?).

assay calibration
E. Calibration not released Reagent handling • Have you handled the reagents
• Reagent kit not within allowed stability after opening. and calibrators according to the
Values below minimum signal • Reagent kit expiry date exceeded . pack. insert?
(valid for quantitative and • Reagent kit stressed (storage or transport conditions not as • Carry out a new assay calibration (new
qualitative assays), or signal recommended e.g. temperature, upright position). reagent pack or new CalSet
difference between CalSet 1 • Reagent kit not at proper temperature. necessary?).
and CalSet 2 or maximum • Foam on assay or system reagents. • Have you performed recommended
signal out of limits (valid for maintenance?
qualitative assays). Calibrator / calibration handling • Call service (carry out APC tests?).
• Foam on calibrator
Calibration factor (new • Calibrator- / Calibration handling (frequency) not as
calculation in SW, see point 6 recommended.
assay calibration) out of limits • Reconstituted calibrator not transferred to the correct bar-
(only valid for quantitative coded calibrator vials e.g. CalSet 1 transferred to CalSet 1
assays). and 2 vial.
• Calibrators not within allowed stability after opening and/or
reconstitution.
• Calibrator not at proper temperature.
• “Bad” lot calibration => calibration factor not released
Others
* Microbead mixing speed out of specification.
* Microbead mixer shape bent.
* S/R Probe adjustment not correct.
* LLD adjustment not correct.
* Magnet adjustment not correct.
* Sipper adjustment not correct.
Additional information Sometimes calibration can be released but problems occur with:
• Recovery of controls.
• Recovery in method comparisons.
Please check calibration counts.

recovery of controls
Control values out of range • Have you handled the reagents
and calibrators according to the
a) only controls? Control handling pack. insert?
• Control not within allowed stability after opening and • Use another control vial.
or reconstitution. • Carry out a new assay calibration
• Control expiry date exceeded. (new reagent pack and CalSet
• Foam on controls. necessary?).
• Controls not at proper temperature. • Have you performed
• Control handling not as recommended. recommended maintenance?
• Call service (check adjustments,
b) controls and samples? Reagent handling carry out APC tests, carry out
• Reagent kit not at proper temperature. service maintenance?).
• Reagent kit not within allowed stability after opening.
• Reagent kit expiry date exceeded.
• Reagent kit stressed (storage or transport conditions not as
recommended e.g. temperature, upright position).
• Foam on assay reagents or system reagents.
Calibrator handling
• Recommended calibration frequency not followed (see point
6 assay calibration).
• Calibration not carefully carried out.
Others
• Hardware failure.
* Measuring Cell (MC), Photomultiplier (PMT), incubator or
system reagent temperature not within specifications.
2.5 Complaints concerning intra Possible causes Actions/Prevention

assay precision
Intra assay precision out of expected • Foam on assay or system reagents. • Have you handled the reagents
range • Reagent kits and/or sample not at proper temperature and calibrators according to the
(drift!). pack. insert?
• Air bubbles in the distilled water container when refilling the • Careful refilling of the water
container with distilled or deionized water. container (not to cold degassed
• Hardware failure. water).
excluding explained individual false * Microbead mixer speed not within specifications. • Have you performed
measurements * Microbead mixer shape bent. recommended maintenance?
(see top 2.1 this chapter) * S/R Probe adjustment not ok. • Call service (check bead mixer,
* Measuring Cell (MC) defective (lifetime 1 year or 50000 check adjustments, carry out
cycles warrantee). APC tests, check MC cycles,
* Tubings or seals not tight. carry out service maintenance?).
* Clogged distilled water filter (MD6).
* Clogged heat pipe.
2.6 Complaints concerning inter Possible causes Actions/Prevention

assay precision
Inter assay precision out of expected • Foam on assay or system reagents. • Have you handled the reagents
range • Reagent kit and/or sample not at proper temperature and calibrators according to the
(drift!). pack. insert?
• Reagent kit stressed (storage or transport conditions not as • Careful refilling of the water
recommended e.g. temperature, upright position), when container (not to cold degassed
bottle change over. water).
excluding explained individual false • Calibration not carefully carried out. • Have you performed
measurements • Recommended calibration frequency not followed (see recommended maintenance?
(see top 2.1 this chapter) point 6 assay calibration). • Call service (check adjustments,
• Air bubbles in the distilled water container when refilling the check bead mixer, carry out APC
container with distilled or deionized water. tests, carry out service
• Hardware failure. maintenance?).
* Microbead mixer speed not within specifications.
* Microbead mixer shape bent.
* Measuring Cell (MC) defective (lifetime 1 year or 50000
cycles warranty).
* S/R Probe adjustment not ok.
* Tubings or seals not tight.
* Clogged distilled water filter (MD6).
* Clogged heat pipe.

method comparison
Deviation of method comparison when • Different standardizations (reference material). • Have you handled the reagents
compared with competitors (internal, • Different antibodies (e.g. HCG on Elecsys/ES). and calibrators according to the
external) • Different methods (RIA/ELISA etc.). pack. insert?
• Different units (conversion factor between units • Have you performed
somentimes different from competitor to competitor). recommended maintenance?
• Different sample material +/- anticoagulants. • Call service (check adjustments,
• Recommended calibration frequency not followed (see carry out APC tests?).
point 6 assay calibration).
• Calibration handling not as recommended.
• Patient collective (e.g. too less number of samples used or
samples used which are within a small concentration range
compared to the measuring range).
• Reagent lot to reagent lot variance.
• System to system variance.
• Hardware failure.
* Measuring cell (MC), Photomultiplier (PMT), incubator
and or system reagent temperature not within
specification.
* Sipper adjustment not ok.
* Magnet adjustment not ok.
2.8 Complaints concerning system to Possible causes Actions/Prevention

system variance
Deviation of control and samples when • Recommended reagent, control and sample handling • Have you handled the
measured with different systems. not used. reagents, calibrators, controls
• See support list key parameters for certain problems, and samples according to the
when only one assay will be concerned. pack. insert?
• Hardware failure. • Have you performed
* Incorrect installation (e.g. LFC, HV adjustment or recommended maintenance? .
system volume check etc. not carried out), when all • Call service (carry out APC
assays will be concerned. tests, carry out service
maintenance, renew
installation?).
C. Schäfer, Global Customer Support August 10
3. SUPPORT LISTS
3.1 Expected counts for calibration of all Elecsys® 2010 assays
Assay calibration (mean observed signals)
Please find below a table of the mean assay calibration signals observed on Elecsys® 2010 and cobas e 411.
This signal count lists should only be a hint in which magnitude the assay signals are expected. Please note that it is not necessary to match the listed
counts. These signals should be used as approximate values in order to simplify trouble shooting in case of complaints. We recommend that customer
compare current versus previous measured calibration signals available in instrument / calibration trace screen or calibration print outs.
Please note that the signal hight can differ

* from reagent lot to reagent lot (production tolerances of rare reagents and final product, different raw materials, aging of the reagents) and
* within a reagent pack (aging of reagents on board)
=> that is the reason why a new assay calibration is necessary when using a new reagent lot respectively why it is recommended
to calibrate after one month (when using the same reagent lot) or after seven days (when using the same reagent kit on the analyzer)
* from instrument to instrument
=> therefore it is important to install the instruments as recommended (e.g. the HV-justage should be carried out very carefully)
* from reagent pack to reagent pack (e.g. with Elecsys® Anti-TPO), therefore a calibration is recommended when a new reagent pack is
used, or when the transport and storage of the reagent packs is not as recommended (upright position)).
When the instrument has been carefully installed, the reagent packs have been transported and stored in an upright position and the
reagent handling of the customer is carried out as recommended (stability, evaporation ect.) the signal height of the calibrator counts
should be within a certain range. Nevertheless the assay calibration compensates the lower or higher signal hight, due to the controls and the samples
gets also lower or higher signal hights. Please note: Prior to reporting any patient results, customer has to verify that the obtained control recovery
meet the specified control range.
This data are excerpts of the standardization and Quality Control (QC) release documents of the respective Elecsys® reagents measured in the Roche
standardization / QC department.
This list is updated approx. once a year (in the end of the year) and inbetween for new / improved tests when they have been introduced.
If there are any questions or if lot specific calibration signals are requested, please do not hesitate to contact us.
Reagent type Test CalSet 1 CalSet 1 CalSet 2 CalSet 2

signal (counts) concentration signal (counts) concentration
Thyroid Function FT3 ≈ 120 000 ≈ 2 pmol/l ≈ 11 000 ≈ 40 pmol/l
Test FT4 ≈ 80 000 ≈ 10 pmol/l ≈ 22 000 ≈ 45 pmol/l
T3 ≈ 300 000 ≈ 1.25 nmol/l ≈ 85 000 ≈ 8.5 nmol/l
T4 ≈ 350 000 ≈ 50 nmol/l ≈ 120 000 ≈ 230 nmol/l
TSH ≈ 700 ≈ 0 µIU/ml ≈ 27 000 ≈ 1.5 µIU/ml
T-uptake ≈ 70 000 ≈ 0.25 TBI ≈ 125 000 ≈ 1.1 TBI
TG ≈ 3 500 ≈ 4 ng/ml ≈ 450 000 ≈ 800 ng/ml
Anti-TG ≈ 500 000 ≈ 40 IU/ml ≈ 30 000 ≈ 3 250 IU/ml
Anti-TPO ≈ 300 000 ≈ 35 IU/ml ≈ 140 000 ≈ 350 IU/ml
Anti-TSHR ≈ 65 000 ≈ 1 IU/l ≈ 12 000 ≈ 25 IU/l
Cardiac CK-MB STAT ≈ 2 000 ≈ 1.5 ng/ml ≈ 30 000 ≈ 25 ng/ml
Digoxin ≈ 70 000 ≈ 0.61 ng/ml ≈ 23 000 ≈ 3.61 ng/ml
Digitoxin ≈ 135 000 ≈ 5 ng/ml ≈ 42 000 ≈ 60 ng/ml
Myoglobin STAT ≈ 3 000 ≈ 33 ng/ml ≈ 300 000 ≈ 1300 ng/ml
proBNP II ≈ 4 500 ≈ 140 pg/ml ≈ 80 000 ≈ 2700 pg/ml
Troponin T STAT hs ≈ 1 700 ≈ 18 ng/l ≈ 600 000 ≈ 4 200 ng/l
Hormones ACTH ≈ 1 700 ≈ 15 pg/ml ≈ 12 000 ≈ 120 pg/ml
Cortisol ≈ 100 000 ≈ 12.5 nmol/l ≈ 15 000 ≈ 1000 nmol/l
DHEAS ≈ 150 000 ≈ 5 µg/dl ≈ 25 000 ≈ 750 µg/dl
Estradiol II ≈ 80 000 ≈ 20 pg/ml ≈ 9 000 ≈ 5300 pg/ml
FSH ≈ 7 000 ≈ 1 mIU/ml ≈ 260 000 ≈ 55 mIU/ml
HCG STAT ≈ 3 000 ≈ 10 mIU/ml ≈ 800 000 ≈ 5 000 mIU/ml
HCG+β ≈ 1 200 ≈ 1.5 mIU/ml ≈ 500 000 ≈ 2 000 mIU/ml
LH ≈ 2 500 ≈ 1 mIU/ml ≈ 100 000 ≈ 45 mIU/ml
Progesterone II ≈ 110 000 ≈ 0.2 ng/ml ≈ 4 000 ≈ 53 ng/ml
Prolactin II ≈ 650 ≈ 2 µU/ml ≈ 270 000 ≈ 2 000 µU/ml
SHBG ≈ 2 000 ≈ 0 nmol/l ≈ 100 000 ≈ 40 nmol/l
Testosterone II ≈ 70 000 ≈ 0.4 ng/ml ≈ 5 500 ≈ 11.5 ng/ml

Diabetes C-Peptide ≈ 12 000 ≈ 0.5 ng/ml ≈ 900 000 ≈ 20 ng/ml
Insulin ≈ 5 500 ≈ 5 µU/ml ≈ 200 000 ≈ 300 µU/ml
Preeclampsia PlGF ≈ 2 000 ≈ 5 pg/ml ≈ 120 000 ≈ 1 200 pg/ml
sFlt-1 ≈ 750 ≈ 0 pg/ml ≈ 400 000 ≈ 15 000 pg/ml
Tumor Marker AFP ≈ 10 000 ≈ 5 U/ml ≈ 70 000 ≈ 50 U/ml
CA 125 II ≈ 10 000 ≈ 35 U/ml ≈ 150 000 ≈ 500 U/ml
CA 15-3 II ≈ 13 000 ≈ 15 U/ml ≈ 70 000 ≈ 100 U/ml
CA 19-9 ≈ 10 000 ≈ 20 U/ml ≈ 100 000 ≈ 250 U/ml
CA 72-4 ≈ 3 500 ≈ 1 U/ml ≈ 75 000 ≈ 70 U/ml
CEA ≈ 2 700 ≈ 5 ng/ml ≈ 25 000 ≈ 50 ng/ml
Cyfra 21-1 ≈ 950 ≈ 5 ng/ml ≈ 50 000 ≈ 50 ng/ml
HE4 ≈ 5 000 ≈ 5 pmol/l ≈ 180 000 ≈ 200 pmol/l
NSE ≈ 2 000 ≈ 0.5 ng/ml ≈ 100 000 ≈ 50 ng/ml
Free PSA ≈ 1 800 ≈ 0.1 mIU/ml ≈ 210 000 ≈ 20 ng/ml
Total PSA ≈ 600 ≈ 0 ng/ml ≈ 550 000 ≈ 60 ng/ml
S100 ≈ 2 000 ≈ 0.2 ng/ml ≈ 45 000 ≈ 2 ng/ml
Down’s syndrome Free ßhCG ≈ 10 000 ≈ 1 IU/l ≈ 550 000 ≈ 64 IU/l
screening PAPP-A ≈ 10 000 ≈ 75 mIU/l ≈ 400 000 ≈ 2 500 mIU/l
Anaemia Vitamin B12 ≈ 20 000 ≈ 100 pg/ml ≈ 3 000 ≈ 1 500 pg/ml
Ferritin ≈ 3 200 ≈ 10 ng/ml ≈ 70 000 ≈ 300 ng/ml
Folate III ≈ 70 000 ≈ 4 ng/ml ≈ 13 000 ≈ 17 ng/ml
Bone β-CrossLaps ≈ 2 000 ≈ 0.05 ng/ml ≈ 20 000 ≈ 2 ng/ml
hGH ≈ 900 ≈ 0 ng/ml ≈ 100 000 ≈ 10 ng/ml
N-MID Osteocalcin ≈ 1 000 ≈ 0 ng/ml ≈ 1 300 000 ≈ 280 ng/ml
PTH STAT ≈ 1 100 ≈ 0.05 pg/ml ≈ 280 000 ≈ 4500 pg/ml
PTH (1-84) ≈ 700 ≈ 0.1 pg/ml ≈ 32 000 ≈ 420 pg/ml
total P1NP ≈ 20 000 ≈ 25 µg/l ≈ 400 000 ≈ 850 µg/l
Vitamin D total ≈ 150 000 ≈ 2 ng/ml ≈ 50 000 ≈ 45 ng/ml
Varia IgE II ≈ 3 100 ≈ 1 IU/ml ≈ 125 000 ≈ 100 IU/ml
Rheumatoid Arthritis Anti-CCP ≈ 3 000 ≈ 20 U/ml ≈ 190 000 ≈ 200 U/ml
Sepsis BRAHMS PCT ≈ 1 700 ≈ 0.1 ng/ml ≈ 640 000 ≈ 54 ng/ml
IL-6 ≈ 2 000 ≈ 18 pg/ml ≈ 40 000 ≈ 700 pg/ml

Hepatitis Anti-HAV ≈ 30 000 negative ≈ 5 000 ≈ 40 IU/l
Anti-HAV IgM ≈ 750 negative ≈ 12 000 positive
Anti-HBc ≈ 140 000 negative ≈ 400 positive
Anti-HBc IgM ≈ 1 000 negative ≈ 40 000 positive
Anti-HBe ≈ 600 000 negative ≈ 2 500 positive
HBeAg ≈ 600 negative ≈ 50 000 positive
Anti-HBs ≈ 1 700 ≈ 10 IU/l ≈ 42 000 ≈ 450 IU/l
HBsAg ≈ 650 negative ≈ 4 000 positive
HBsAg II ≈ 1 000 negative ≈ 6 000 positive
HBsAg II quant ≈ 900 negative ≈ 5 500 ≈ 5 IU/ml
Anti-HCV ≈ 600 negative ≈ 20 000 positive
Retroviruses HIV Ag ≈ 750 negative ≈ 35 000 positive
HIV combi ≈ 2 500 negative ≈ 55 000 positive
HIV combi PT ≈ 2 300 negative ≈ 35 000 positive
Torch CMV IgG ≈ 700 negative ≈ 150 000 ≈ 40 U/ml
CMV IgG Avidity ≈ 900 negative ≈ 190 000 ≈ 40 U/ml
CMV IgM ≈ 900 negative ≈ 7 000 positive
HSV-1 IgG ≈ 5 000 negative ≈ 115 000 positive
HSV-2 IgG ≈ 1 600 negative ≈ 95 000 positive
Rubella IgG ≈ 11 000 negative ≈ 300 000 ≈ 400 IU/ml
Rubella IgM ≈ 900 negative ≈ 9 000 ≈ 700 U/ml
Toxo IgG ≈ 1 100 negative ≈ 280 000 ≈ 100 IU/ml
Toxo IgM ≈ 800 negative ≈ 11 000 ≈ 130 U/ml
- no information
The counts can also differ between Reagent lots and CalSet lots due to calibrator target values might change.
The above mentioned count differences should not have any effect on the concentrations of analyte in the sample!!!!!!
This table summarizes the mean of data, collected by the QC department.
C. Schäfer, Global Customer Support August 2011
3.2 Assay Summary Elecsys® 2010: LDL, measuring range, stability, CV, etc.
Elecsys 2010 ®Assays

Assay Measuring Reference LDL Reagent Reagent Reagent Dilution Reference material
Cat.no. range range (functional stability stability stability (conc. of or Reference
(total duration sensitivity, if diluted
in min.)
unopened opened on board method /Standar-
[competitive/ available) 2-8°C 2-8°C sample disation
sandwich must be)
assay]
FT3 0.400-50.00 pmol/l * 0.400 pmol/l Expiry date 12 weeks 6 weeks ∅ Equilibrium dialysis
03051986 0.260-32.55 pg/ml 0.260 pg/ml
(18)[c]
FT4 0.300-100.0 pmol/l 12-22 pmol/l 0.30 pmol/l Expiry date 12 weeks 4 weeks ∅ Enzymun-Test® FT4
11731297 0.023-7.77 ng/dl 0.93-1.7 ng/dl 0.023 ng/dl (this in turn was
(18)[c] * calibrated using
equilibrium dialysis)
T3 0.300-10.00 nmol/l 1.3-3.1 nmol/l 0.300 Expiry date 12 weeks 8 weeks ∅ Reference standards
11731360 0.195-6.51 ng/ml 0.8-2.0 ng/ml nmol/ml by weighing the T3
(18)[c] * 0.195 ng/ml into analyte-free
human serum matrix
T4 5.40-320.0 nmol/l 66-181 nmol/l 5.40 nmol/l Expiry date 12 weeks 8 weeks ∅ ID-GC/MS (isotope
12017709 0.420-24.86 μg/dl 5.1-14.1 μg/dl 0.42 μg/dl dilution gas
(18)[c] * chromatography mass
spectrometry)
TSH 0.005-100.0 μIU/ml 0.27-4.2 0.005 μIU/ml Expiry date 12 weeks 8 weeks Diluent WHO reference
11731459 μIU/ml * (0.014 MA standard
(18)[s] µIU/ml) 1:10
(> 10
μIU/ml)
* Please check in package insert. ∅ Dilution not necessary due to the broad measuring range or can not be diluted because of changing in the concentration of the
binding proteins alters the equilibrium.

Assay Measuring Reference LDL Reagent Reagent Reagent Dilution Reference
Cat.no. range range (functional stability stability stability (conc. of material or
(total duration sensitivity, if diluted
in min.)
unopened opened on board Reference
[competitive/ available) 2-8°C 2-8°C sample method /Standar-
sandwich must be) disation
assay]
T-uptake 0.200-1.90 TBI 0.8-1.3 TBI * 0.200 TBI Expiry date 12 weeks 8 weeks ∅ Clinically defined
11731394 human serum panel
(18)[modified c] with a mean TBI of
1.0
TG 0.100-1000 ng/ml 1.4-78 ng/ml * < 0.1 ng/ml Expiry date 12 weeks 8 weeks 1:5 CRM (Certified
05118921 (< 1ng/ml) (> 50 ng/ml) Reference Material)
(18)[s]  457
Anti-TG 10-4000 IU/ml * < 10 IU/ml Expiry date 12 weeks 6 weeks @ NIBSC
06368697
(18)[c]
Anti-TPO 5-600 IU/ml * < 5 IU/ml Expiry date 6 weeks 2 weeks @ 1:5 with NISBC
06368590 Dil. Uni.
(18)[c] manually
(> 100
IU/ml)
Anti- 0.3-40 IU/l * ~ 0.3 IU/l Expiry date 3 weeks* 3 weeks* Neg. NISBC
TSHR# human sera
04388780 1:5 or 1:10
(27)[c] (> 4 IU/l)*
* Please check in package insert.  until further notice only one set of pretreatement reagent kit can be placed on the analyzers.
∅ Dilution not necessary due to the broad measuring range or can not be diluted because of changing in the concentration of the binding proteins
alters the equilibrium.
@ The autoantibodies are heterogeneous and this gives rise to non-linear dilution phenomena.
# Calibrators are part of the test kit.  Confirmatory test available (cat.no. 05107555)
Assay Measuring Reference LDL Reagent Reagen Reagent Dilution Reference

Cat.no. range range (functional stability t stability (conc. of material or
(total duration sensitivity, diluted
in min.)
unopened stability on Reference
[competitive/ if available) 2-8°C opened board sample method /Standar-
sandwich
2-8°C must be) disation
assay]
CK-MB 0.300-300 ng/ml * 0.300 ng/ml Expiry date 12 weeks 6 weeks Dil MA 1:2 Abbott IMx
05957648/ (1 ng/ml) (> 50 ng/ml)
05894808
# (9/18)[s]
Myoglobin 21-3000 ng/ml Men 28 - 72 ≤ 21 ng/ml Expiry date 12 weeks 8 weeks 1:10 Inhouse reference
11820788/ ng/ml (> 50 ng/ml) preparation
12178214 Women 25-58
# (9/18)[s] ng/ml
*
proBNP II 5-35000 pg/ml * 5 pg/ml Expiry date 12 weeks 8 weeks 1:2 Elecsys® proBNP
04842464 0.6-4130 0.6 pmol/l (> 15000
(18)[s] pmol/l (< 50 pg/ml, pg/ml,
< 5.9 > 1770
pmol/l) pmol/l)*
Troponin T 3-10000 ng/l < 100 ng/l ≤ 5 ng/l Expiry date 12 weeks 4 weeks Diluent MA Elecsys® Troponin T
hs * (≤ 13 ng/l) 1:10 STAT (this in turn was
05092728 / (> 1000 ng/l) calibrated using
05092744 Enzymun-Test®
# (9/18)[s] Troponin T
* Please check in package insert.
# Assays are also available as STAT assays (9 minutes total duration). Assays with 18 minutes total duration has been calibrated against the related
STAT assays. This in turn was calibrated see above.
Assay Measuring Reference LDL/LoD Reagent Reagent Reagent Dilution Reference

Cat.no. range range (functional stability stability stability (conc. of material or
in min.)
unopened opened on board Reference
[competitive/ if available) 2-8°C 2-8°C sample method /Standar-
sandwich must be) disation
assay]
Troponin I 0.16-25 ng/ml * 0.16 ng/ml Expiry date 4 weeks 2 weeks 1:10 with Commercially
05094798 Dil. MA available troponin I
# (9)[s] (> 3 ng/ml) assay

# Assays are also available as STAT assays (9 minutes total duration). Assays with 18 minutes total duration has been calibrated against the related
STAT assays. This in turn was calibrated see above.
Assay Measuring Reference LDL Reagent Reagen Reagent Dilution Reference

Cat.no. range range (functional stability t stability (conc. of material or
in min.)
unopened stability on Reference
[competitive/ if available) 2-8°C opened board sample method
sandwich
2-8°C must be) /Standar-
assay]
disation
Digoxin 0.15-5.0 ng/ml therapheutic 0.15 ng/ml Expiry date 12 weeks 8 weeks 1:2 By weighing
11820796 0.19-6.4 nmol/l range 0.19 nmol/l (> 2.5ng/ml United States
(18)[c] 0.9-2.0 ng/ml > 3.2 nmol/l) Pharmacopoeia
1.2-2.6 nmol/l (USP) digoxin
* reference
material into
analyte free
human serum
Digitoxin 2.00-80.0 therapheutic 2.00 ng/ml Expiry 12 4 weeks 1:2 Reference
03002659 ng/ml range 2.62 nmol/l date weeks (> 30 ng/ml standards by
(18)[c]
2.62-105 10-30 ng/ml > 39 nmol/l) weighing
nmol/l 13-39 nmol/l digitoxin
*
HCG STAT 0.5-10000 * 0.5 mIU/ml Expiry date 12 weeks 4 weeks 1:100 NIBSC
03300811 mIU/ml (> 100 standard
(9)[s] mIU/ml)
HCG+β 0.100-10000 * 0.1 mIU/ml Expiry date 12 weeks 4 weeks 1:100 NIBSC
03271749 mIU/ml (< 0.6 (> 100 standard
(18)[s] mIU/ml) mIU/ml)

Assay Measuring Referen- LDL Reagent Reagen Reagen Dilution Reference material or
Cat.no. range ce range (functional stability t t (conc. of Reference method
(total duration in sensitivity, if diluted sample
min.)
unopene stability stability /Standardisation
[competitive/ available) d opened on must be)
sandwich assay]
2-8°C 2-8°C board
ACTH 1.0-2000 * 1.0 pg/ml Expiry 12 weeks 4 weeks ∅ Gravimetically with
03255751 pg/ml 0.22 pg/ml date synthetic ACTH
(18) [s] 0.22-440 produced at Roche •
pmol/l
Cortisol 0.5-1750 * < 0.5 nmol/l Expiry date 12 weeks 8 weeks 1:10 Enzymun-Test® Cortisol
11875116 nmol/l (< 8.5 nmol/l) (> 50 nmol/l (this in turn was
(18)[c] 0.018-63.4 < 0.018 µg/dl > 1.8 µg/dl) calibrated via ID-MS)
µg/dl (< 0.308 * (for urine
µg/dl) samples)
DHEA-S 0.003-27 * 0.003 µmol/l Expiry date 12 weeks 8 weeks diluent: low Gravimetrically produced
03000087 µmol/l 0.10 µg/dl concentrated master calibrators
(18)[c] 0.100-1000 human sera 1:5 consisting of exactly
µg/dl (> 1.5 µmol/l defined DHEA-S
> 45 µg/dl) concentrations in
* depleted human serum
matrix.
Estradiol II 18.4-15781 * 18.4 pmol/l Expiry date 12 weeks 8 weeks diluent MA ID-GC/MS
03000079 pmol/l (44 pmol/l) 1:5
(18)[c] 5.00-4300 5.0 pg/ml (> 1835 pmol/l
pg/ml (12 pg/ml) > 500 pg/ml)*
FSH 0.100-200.0 * ≤ 0.10 Expiry date 12 weeks 8 weeks ∅ Enzymun-Test® FSH
11775863 mIU/ml mIU/ml (this in turn was
(18)[s] calibrated using WHO-
reference standard)
* Please check in package insert. ∅ Dilution not necessary due to the broad measuring range.

Assay Measuring Reference LDL Reagent Reagent Reagent Dilution Reference material or
Cat.no. range range (functional stability stability stability (conc. of Reference method
(total duration in sensitivity, if diluted
min.)
unopene opened on board /Standardisation
[competitive/ available) d 2-8°C sample
sandwich assay]
2-8°C must be)
LH 0.100-200 * 0.10 mIU/ml Expiry 12 weeks 8 weeks ∅ 2nd International Standard
11732234 mIU/ml date (NIBSC)
(18)[s]
Progeste- 0.095-191 * 0.095 nmol/l Expiry 12 weeks 8 weeks Diluent ID-GC/MS
rone II nmol/l (0.48 nmol/l) date E2/Prog
12145383 0.030-60.0 0.03 ng/ml 1:10
(18)[c] ng/ml (0.15 ng/ml) (> 6 nmol/l
> 2 ng/ml)
Prolactin II 1-10000 * 1 µIU/ml Expiry 12 weeks 8 weeks 1:10 WHO-reference standard
03203093 µIU/ml 0.047 ng/ml date (> 50 µIU/ml
(18)[s] 0.047-470 > 2.4 ng/ml)
ng/ml
SHBG 0.35-200 * 0.35 nmol/l Expiry 12 weeks 7 weeks Diluent MA 1st International
03052001 nmol/l date 1:10 Standard (NIBSC)
(18)[s] (> 20 nmol/l)
*
Testosterone 0.087-52 * ≤ 0.087 nmol/l Expiry 12 weeks 8 weeks ∅ ID-GC/MS
II nmol/l (≤ 0.416 date
05200067 0.025-15 nmol/l)
(18)[c] ng/ml ≤ 0.025 ng/ml
(≤ 0.12 ng/ml)
∅ Dilution not necessary due to the broad measuring range.

Assay Measuring Reference LDL/LoD Reagent Reagent Rea- Dilution Reference material or
Cat.no. range range (functional stability stability gent (conc. of Reference method
(total duration in sensitivity, diluted
min.)
unopened opened stability /Standardisation
[competitive/ if available) 2-8°C 2-8°C on sample
sandwich assay]
board must be)
C-Peptide 0.003-13.3 * 0.003 nmol/l Expiry date 12 weeks 8 weeks Diluent MA WHO International
03184897 nmol/l 0.01ng/ml 1:10 Reference Reagent
(18)[s] 0.01-40 (> 4 ng/ml, >
ng/ml 1.3 nmol/l)
Insulin 0.20-1000 2.6-24.9 0.20 µU/ml Expiry date 12 weeks 4 weeks ∅ WHO-reference standard
12017547 µU/ml µU/ml 1.39 pmol/l
(18)[s] 1.39-6945 17.8-173
pmol/l pmol/l *
PlGF 3-10000 pg/ml * ≤ 3 pg/ml Expiry date 12 weeks 6 weeks ∅ Commercially available
05144671 PlGF assay
(18)[s]
sFlt-1 10-85000 * ≤ 10 pg/ml Expiry date 12 weeks 6 weeks ∅* Commercially available
05109523 pg/ml sFlt-1 assay
(18)[s]

∅ Dilution not necessary due to the broad measuring range.
Assay Measuring Reference LDL Reagent Reagen Reagent Dilution Reference material
Cat.no. range range (functional stability t stability (conc. of or Reference
min.)
unopened stability on method /Standar-
[competitive/ if available) 2-8°C opened board sample disation
sandwich assay]
2-8°C must be)
AFP 0.500-1000 IU/ml ≤ 5.8 IU/ml 0.50 IU/ml Expiry date 12 weeks 8 weeks 1:50 WHO-reference
04481798 0.605-1210 ng/ml ≤ 7.0 ng/ml 0.61 ng/ml (> 20 IU/ml standard
(18)[s] > 24 ng/ml)
*
CA 125 II 0.600-5000 U/ml < 35 U/ml 0.60 U/ml Expiry date 12 weeks 6 weeks 1:5 Enzymun-Test® CA 125
11776223 * (> 1000 U/ml) II (this in turn was
(18)[s] calibrated against CA
125 II RIA from
Fujirebio Diagnostics)
CA 15-3 II # 1.00-300 U/ml ≤ 25 U/ml < 1.00 U/ml Expiry date 12 weeks 5 weeks 1:10 Elecsys® CA 15-3
11776169 * (> 30 U/ml)
(18)[s]
CA 19-9 0.600-1000 U/ml ≤ 27 U/ml < 0.60 U/ml Expiry date 8 weeks 8 weeks 1:10 Enzymun-Test® CA 19-
11776193 * (> 50 U/ml) 9
(18)[s]
CA 72-4 0.200-300 U/ml < 6.9 U/ml < 0.20 U/ml Expiry date 12 weeks 8 weeks 1:2 Enzymun-Test® CA 72-
11776258 * (1.0 U/ml) (> 150 U/ml) 4
(18)[s]
CEA 0.200-1000 ng/ml * 0.20 ng/ml Expiry date 12 weeks 6 weeks 1:50 WHO-reference
11731629 (> 20 ng/ml) standard
(18)[s]
* Please check in package insert. # Elecsys® Universal Diluent needed for pre-dilution.
Assay Measuring Reference LDL Reagent Reagen Reagent Dilution Reference material
Cat.no. range range (functional stability t stability (conc. of or Reference
min.)
unopened stability on method /Standar-
[competitive/ if available) 2-8°C opened board sample must disation
sandwich assay]
2-8°C be)
Cyfra 21-1 0.100-500 ng/ml < 3.3 ng/ml ≤ 0.10 ng/ml Expiry date 12 weeks 8 weeks 1:2 Enzymun-Test® Cyfra
11820966 * (> 250 ng/ml) 21-1
(18)[s]
HE4 15.0-1500 pmol/l * 15.0 pmol/l expiry date 12 weeks 28 days Diluent MA HE4 EIA method from
05950929 (20.0 pmol/l) 1:20 Fujirebio Diagnostics, Inc.
(18)[s] (> 75 pmol/l)
NSE 0.05-370 ng/ml < 16.3 ng/ml <0.05 ng/ml Expiry date 12 weeks 8 weeks Elecsys® Enzymun-Test® NSE
12133113 * (0.25 ng/ml) Diluent NSE
(18)[s] 1:2
(> 50 ng/ml)
free PSA 0.010-50.00 ng/ml * ≤ 0.01 ng/ml Expiry date 12 weeks 6 weeks ∅ WHO standard
03289788 (0.02 ng/ml) (100% free PSA)
(18)[s]
total PSA 0.002-100 ng/ml age dependend 0.002 ng/ml Expiry date 12 weeks 8 weeks 1:50 Stanford reference
04641655 * (0.03 ng/ml) (> 2 ng/ml) standard
(18)[s] (90% PSA-ACT + 10%
free PSA)
S100 0.005-39 μg/l * < 0.005 μg/l Expiry date 12 weeks 8 weeks 1:5 with S 100 Weighed-out S100 β/β
03175243 (< 0.02 μg/l) negative protein
(18)[s] human sera or
CalSet 1
(> 1 μg/l)
Please check in package insert.
Elecsys® 2010 / cobas® e 411 Assays
(total duration in sensitivity, unopened opened on board diluted method /Standar-
min.)
[competitive/ if available) 2-8°C 2-8°C sample disation
sandwich assay] must be)
Free ßhCG 0.1-190 IU/l < 0.13 IU/l < 0.1 IU/l Expiry date 4 weeks 4 weeks 1:10 NIBSC
04854071 * (0.5 IU/l) (> 19 IU/l)
(18)[s]
PAPP-A 4-10000 mIU/ll < 7.15 mIU/l < 4 mIU/l Expiry date 4 weeks 3 weeks 1:10 Commercially
04854098 * (20 mIU/l) (> 500 mIU/l) available PAPP-A
(18)[s] Test *
min.)
[competitive/ if available) 2-8°C 2-8°C sample disation
sandwich assay] must be)
Vitamin B12 30-2000 pg/ml 243-894 30 pg/ml Expiry date 12 weeks 5 weeks 1:2 Commercially
04745736 22-1476 pmol/l pg/ml 22 pmol/l (> 1000 available radiobinding
(27)[c] 179-660 pg/ml B12 assay
 pmol/l > 738
* pmol/l)
Ferritin 0.500-2000 ng/ml * 0.5 ng/ml Expiry date 12 weeks 6 weeks 1:50 Elecsys® Ferritin
03737551 (> 40 ng/ml) cat.no. 11820982*
04491785
(18)[s]
Folate III 0.64-20 ng/ml * ≤ 0.64 Expiry date 8 weeks 2 weeks 1:2 Elecsys® Folate II
03253678 1.45-45.4 nmol/l ng/ml manually cat.no. 03253678
(27)[c] ≤ 1.45 (> 10 ng/ml
 nmol/l > 22.7
nmol/l)
RBC Folate * * * Expiry date 14 days - * *
Hemolyzing
Reagent
12017741
 Pretreatment assay

Assay Measuring Reference LDL/LoD Reagent Reagent Reagent Dilution Reference material
(total duration in sensitivity/ diluted
min.)
[competitive/ LoQ, if 2-8°C 2-8°C sample disation
sandwich assay] available) must be)
β-CrossLaps/ 0.010-6.00 ng/ml * 0.01 ng/ml Expiry date 12 weeks 8 weeks ∅ Reference standards
serum 10-6000 pg/ml 10 pg/ml precisely defined by
11972308 (< 0.07 ng/ml weihghing out synthetic
(18)[s] < 70 pg/ml) peptide
hGH 0.030-50.0 ng/ml * 0.030 ng/ml expiry date 84 days 56 days 1:2 IRP, NIBSC code 98/574
05390125 (0.050 ng/ml) (> 50 ng/ml)
(18)[s]
N-MID 0.5-300 ng/ml * < 0.50 ng/ml Expiry date 12 weeks 8 weeks 1:5 In-house reference
Osteocalcin (> 60 ng/ml) standards: osteocalcin in
12149133 analyte-free human serum
(18)[s] matrix
PTH 1.2-5000 pg/ml 15-65 pg/ml 1.2 pg/ml Expiry date 12 weeks 8 weeks ∅ Commercially available
04892470/ 0.127-530 pmol/l 1.6-6.9 pmol/l 0.127 pmol/l PTH test (RIA)
11972103 * (6.0 pg/ml
9/18)[s] 0.64 pmol/l)
PTH (1-84) 5.5-2300 pg/ml * 5.5 pg/ml Expiry date 84 days 56 days 1: 2 WHO international
05608546 0.583-244 pmol/l (10 pg/ml*) (> 1150 pg/ml) standard 95/646
(18)[s]
Total P1NP 5-1200 µg/l * 5 µg/l Expiry date 8 weeks 8 weeks 1:2 Reference standards
03141071 (> 100 µg/l) precisely defined by
(18)[s] weighing native P1NP into
an analyte-free human
serum matrix
Vitamin D total 3.00-700 ng/ml * 3 ng/ml Expiry date 56 days 21 days Manual dilution LC-MS/MS
05894913 7.50-175 nmol/l 7.5 nmol/l with Dil. Uni 1:2
(27)[c] (> 35 ng/ml,
> 87.5 nmol/l)
* Please check in package insert. ∅ Dilution not necessary due to the broad measuring range
Elecsys® 2010 Assays
Assay Measuring range Reference LDL Reagent Reagent Reagent Dilution Reference material
Cat.no. range (functional stability stability stability (conc. of or Reference
(total duration in sensitivity, unopened opened on board diluted method /Standar-
min.)
[competitive/ if available) 2-8°C 2-8°C sample must disation
sandwich assay] be)
IgE II 0.100-2500 IU/ml * 0.10 IU/ml Expiry date 12 8 weeks 1:20 WHO-reference
04827031 0.240-6000 ng/ml 0.24 ng/ml weeks (> 125 IU/ml standard
(18)[s] (0.50 IU/ml > 300 ng/ml)
1.20 ng/ml)
Anti-CCP 7-500 U/ml * 7 U/ml Expiry date - 1 week diluent: Commercially
05031656 (8 U/ml) * negative available second-
(18)[s] human serum generation anti-CCP
pool assay
1:2 to 1:5
BRAHMS PCT 0.02-100 ng/ml 0.046 ≤ 0.02 Expiry date 12 4 weeks diluent: BRAHMS PCT LIA
05056888 ng/ml* ng/ml weeks negative
(18)[s] (≤ 0.06 human serum
ng/ml) 1:4
(> 1.0
ng/ml)
IL-6 1.5-5000 pg/ml 7 pg/ml* Approx. 1.5 Expiry date 12 weeks 4 weeks 1:10 Dil MA NIBSC 1st 89/548
05109442 pg/ml (> 50 pg/ml) standard
(18)[s]

Assay Measuring Reference LDL Clinical Clinical Reagent Reagent Reagent Dilution Reference
Cat.no. Range range sensitivity specificit stability stability stability material or
(total duration
in min.)
y unopened opened on board Reference
[competitive/ 2-8°C 2-8°C method
sandwich
assay]
/Standar-
disation
Anti-HAV 3.00-60 IU/l Concentrations < 3.0 IU/l * 98.85% Expiry date 8 weeks 8 weeks Diluent Second
04854977 < 20 IU/l are * Hepatitis International
(18)[c] non-reactive A Standard for
* (> 20 Anti-Hepatitis
A, NIBSC
IU/ml) *
code 97/646
Anti-HAV - Cut off index < * 98.3-100% 100% Expiry date 8 weeks 8 weeks possible Roche
IgM # 1 are non- (95% reference
11820591 reactive confidence * * standard
(18) [µ-Capture] range) *
*
Anti-HBc - Cut off index > < 0.8 PEI 100% 99.6% Expiry date 8 weeks 8 weeks possible ”HBc-
11820559 1 are non- U/ml resp. * Reference
(27)[c] reactive * 99.7% material 82
* * (IgG anti-
HBc)” of the
Paul Ehrlich
Institute
Anti-HBc - Cut off approx. < 3.0 100% 100% Expiry date 8 weeks 4 weeks possible "HBc
IgM # 100 PEI U/ml, PEI-E/ml * * Reference
11820567 equival cut off serum IgM 84
(18) [µ-Capture] index is 0.9- (IgM anti-
HBc)" of the
1.1 *
Paul Ehrlich
Institute
* Please check in package insert. - no information # Elecsys® Universal Diluent needed for pre-dilution.

Cat.no. Range range sensitivity specificit stability stability stability (conc. of material or
(total diluted
duration in
y unopened opened on Reference
min.) 2-8°C 2-8°C board sample method
[competitive/ must be) /Standar-
sandwich
assay] disation
Anti-HBe - Cut off < 0.2 PEI * 99.9% Expiry date 8 weeks 8 weeks possible ”HBe-
11820613 index > 1.0 U/ml resp. * Reference
(18) [c] are non- 100% material 82 (IgG
reactive * * anti-HBe)” of
the Paul Ehrlich
Institute
HBeAg - Cut off ≤ 0.30 * 100% Expiry date 8 weeks 8 weeks possible ”HBe-
11820583 index < 1.0 U/ml * * Reference
(18) (s) are non- Antigen 82
reactive (HBe-Ag)” of
* the Paul Ehrlich
Institute
Anti-HBs 2 - 1000 IU/l Concentrati ≤ 2.0 IU/l 99% 99.8% Expiry date 8 weeks 4 weeks 1:100 WHO-reference
11820524 ons < 10 * * (> 10 standard
(18)[s] IU/l are IU/l)
non-
reactive*
HBsAg II - Cut off PEI Std. 99.9% IR (initial Expiry date 8 weeks 4 weeks * NIBSC
04687787 index < 0.9 ay: ≤ 0.04 reactive) standard
(18)[s] are not E/ml 99.91%
reactive ad: ≤ 0.04 RR
* E/ml (repeated
WHO Std. reactive)
ad: ≤ 0.1 99.98% *
IU/ml
Assay Measuring Reference LDL/LoD Clinical Clinical Reagent Reagent Reagent Dilution Reference
Cat.no. Range range sensitivit specificity stability stability stability (conc. of material
(total duration in diluted
min.)
y unopene opened on board or
[competitive/ d 2-8°C sample Reference
sandwich assay]
2-8°C must be) method
/Standar-
disation
HBsAg II quant 0.05-130 0.05 IU/ml - - Expiry 8 weeks 8 weeks 1:100 with NISBC
05957435 IU/ml * date Diluent standard
(18)[s] (undiluted Universal
samples)
HBsAg Confir- - x > 50% = * * * Expiry 8 weeks - * *

matory Test neg. or date
11820648 * false-
reactive
*
Anti-HCV - Cut off * * Expiry - 72 hours on - *
03290352 index < 0.9 date board, 2
(18)[s] are non weeks if
reactive stored
Cut off alternately
index ≥ 0.9- in the fridge
<1.0 are in and on the
the gray analyzer
zone (up to 40
hours)*
* Please check in package insert. - no information
(total duration diluted
in min.)
y unopened opened on board Reference
[competitive/ 2-8°C 2-8°C sample method
sandwich must be) /Standar-
assay]
disation
HIV Ag - Cut off index ≤ 4.0 * * Expiry date 4 weeks 4 weeks - NIBSC
11971611 < 0.9 are not pg/ml code 90/636
(18)[s] reactive
Cut off index
0.9-<1.0 are
deemded
borderline
HIV Ag - x < 50% = * * * Expiry date 4 weeks - - *
Confir- neg. or false-
matory Test reactive
12001101 * *
HIV combi - Cut off index < 6 U/ml 100% (95% 99.76% expiry date 4 weeks* 2 weeks; 70 - Antigen: 1st
04860446 < 0.9 are not (antigen- conf. limit = (blood h in case of Int. Ref.
(18)[s] reactive sensitivity) 99.8%) donors); alternate Reagent
Cut off index 99.42% storage at 1992, 90/636
0.9-<1.0 are (others) 2-8°C and (NIBSC)
deemed 20-25°C
borderline during 4
weeks
- no information
Elecsys® 2010 / cobas e 411 Assays
Assay Measuring Reference LDL / Clinical Clinical Reagent Reagent Reagent Dilution Reference
Cat.no. Range range Detection sensitivity specificit stability stability stability (conc. of material or
(total duration in limit unopened opened on board diluted Reference
min.) y
assay] disation
HIV combi - Cut off index < < 2 IU/ml 100% (95% 99.88% expiry date 12 weeks 4 weeks - NIBSC, code
PT 0.9 are non- conf. limit = (blood 90/636
05390095 reactive 99.76%) donors)*
(27)[s] Cut off index
0.9-<1.0 are
borderline
Cut off index ≥
1 are reactive
CMV IgG 0.25-500 * 0.25 U/ml - - expiry date 12 weeks 3 weeks 1:20 Internal Roche
04618815 U/ml (> 15 standard for
(18)(s) U/ml) CMV IgG
CMV IgG 0.25-500 * 0.25 U/ml - - expiry date 12 weeks 3 weeks* 1:20 Internal Roche
Avidity U/ml manually standard for
05909708 with CMV IgG
(18)(s) Diluent.
Universal
(> 15
U/ml)
(total duration
in min.)
y unopened opened on board diluted Reference
assay]
disation
CMV IgM - Cut off index < - - - expiry date 12 weeks 2 weeks; - Roche
04618858 0.8 are not 84 h in standard
(18)[µ- reactive case of
capture) Cut off index ≥ alternate
0.8 - < 1.0 COI storage at
are 2-8°C and
indeterminate 20-25°C
Cut off index ≥ during 12
1 are reactive weeks
HSV-1 IgG - Non-reactive < - - - expiry date 8 weeks 28 days - Roche
05572185 0.6 COI standard
(18)[s] Gray-zone: ≥
0.6-<1.0 COI
Reactive ≥ 1.0
COI
HSV-2 IgG - Non-reactive < - - - expiry date 8 weeks 28 days - Roche
05572193 0.51 COI standard
(18)[s Gray-zone: ≥
0.51-<1.0 COI
Reactive ≥ 1.0
COI
- no information
(total duration
in min.)
assay]
disation
Rubella IgG 0.17-500 * 0.17 IU/ml - - expiry date 12 weeks* 2 weeks, 1:20 1st
04618793 IU/ml 84 h in (> 10 International
(18)[s] case of IU/ml) Standard for
alternate Anti-Rubella
storage at Immun-
2-8°C and globulin
20-25°C
during 12
weeks
Rubella - Cut off index - * * expiry date 12 weeks* 2 weeks; - Roche
IgM < 0.8 are not 84 h in standard
04618831 reactive case of
(18)[µ-capture) Cut off index alternate
≥ 0.8 - < 1.0 storage at
COI are 2-8°C and
Cut off index during 12
≥ 1 are weeks
reactive
- no information
(total duration
in min.)
assay]
disation
Toxo IgG 0.13-650 * 0.125 - - expiry date 12 weeks* 2 weeks, 1:20 3rd
04618815 IU/ml IU/ml 84 h in (> 3 International
(18)(s) case of IU/ml) Standard for
alternate anti-
storage at Toxoplasma
2-8°C and serum
20-25°C (TOXM) from
during 12 NIBSC •
weeks
Toxo IgM - Cut off index - - - expiry date 12 weeks* 2 weeks; - Roche
04618858 < 0.8 are not 84 h in standard
(18)[µ- reactive case of
capture) Cut off index alternate
≥ 0.8 - < 1.0 storage at
COI are 2-8°C and
Cut off index during 12
≥ 1 are weeks
reactive

Assay Specified intraassay internal evaluation Specified interassay internal evaluation
precision measured intraassay precision  measured interassay
precision precision
FT3 3-5 pmol/l 4% CV 1% CV 3-5 pmol/l 6% CV 2% CV
5-10 pmol/l 3% CV 1.3% CV 5-10 pmol/l 6% CV 2.5% CV
10-40 pmol/l 3% CV 1.5, 2.2% CV 10-40 pmol/l 6% CV 2.1, 3.7% CV
< 3 pmol/l (not specified) 3.3% CV < 3 pmol/l (not specified) 5.1% CV
FT4 4-10 pmol/l 4% CV 1.6% CV 4-10 pmol/l 6% CV 3.5% CV
10-20 pmol/l 3% CV 1.7, 1.4% CV 10-20 pmol/l 4% CV 2.7, 3.3% CV
25-100 pmol/l 3% CV 2.9, 1.8% CV 25-100 pmol/l ≤ 7% CV 3.0, 6.6% CV
T3 0.7-1.2 nmol/l 4% CV 3.6% CV 0.7-1.2 nmol/l 6% CV 5.4% CV
1.2-2.5nmol/l 3% CV 4.2, 4.1% CV 1.2-2.5nmol/l 6% CV 4.8, 4.7% CV
2.5-10 nmol/l 3% CV 3.5, 5.3% CV 2.5-10 nmol/l 7% CV 4.1, 5.4% CV
T4 < 50 nmol/l ≤ 5 CV 4.7% CV < 50 nmol/l ≤ 7% CV 6.9% CV
65-160 nmol/l 3% CV 2.7, 2.3% CV 65-160 nmol/l 4% CV 3.7, 3.3% CV
160-250 nmol/l 2.5, 2.0% CV 160-250 nmol/l 3.0, 2.7% CV
3% CV 4%CV
TSH 0.05-0.1 μU/ml 10% CV 8.6% CV 0.01-0.1 μU/ml 20 % CV 8.7, 5.4% CV
0.1-4 μU/ml 5% CV 2.1, 1.8, 1.9% CV 0.1-4 μU/ml 7% CV 2.2, 3.3, 3.6% CV
4-20 μU/ml 2% CV 1.5% CV 4-20 μU/ml 4% CV 1.8% CV
 The system to system precision is defined as interassay precision x 1.5 e.g. 6% interassay precision = 9% system to system precision, when not specified for the test.

precision measured intraassay precision  measured interassay
precision precision
T-uptake 0.6-1.4 TBI 4% CV 2.2, 2.4, 3.3% CV 0.6-0.9 TBI 5% CV
< 0.6 TBI (not specified) 5.1% CV 0.9-1.4 TBI 4% CV 3.7, 2.7, 3.4% CV
> 1.4 TBI (not specified) 0.7% CV < 0.6 TBI (not specified) 11.7% CV
> 1.4 TBI (not specified) 0.9% CV
TG 2-10 ng/ml ≤ 5% CV 1.7, 1.8, 1.8% CV 2-10 ng/ml ≤ 10% CV 2.7, 3.0, 2.6% CV
10-50 ng/ml ≤ 3% CV 1.5, 1.4% CV 10-50 ng/ml ≤ 5% CV 2.5, 2.3% CV
> 50 ng/ml ≤ 5% CV 1.1% CV > 50 ng/ml ≤ 10% CV 1.8% CV
Anti-TG 50-75 IU/ml <15% CV 4.9% CV 50-75 IU/ml < 20% CV 8.7% CV
75-1000 IU/ml < 8% CV 5.5, 5.6, 5.1, 4.6% CV 75-1000 IU/ml < 10% CV 7.2, 6.7, 7.2, 5.9% CV
1000-2000 IU/ml < 13% CV 6.5% CV 1000-2000 IU/ml < 15% CV 8% CV
> 2000 IU/ml < 18% CV 5.6% CV > 2000 IU/ml < 20% CV 6.3% CV
Anti- 15-40 IU/ml ≤ 10% CV 6, 8.8, 7.1% CV 15-40 IU/ml ≤ 15% CV 6.7, 11, 7.7% CV
TPO > 40 IU/ml ≤ 7% CV 3.4, 2.8% CV > 40 IU/ml ≤ 10% CV 4, 4.3% CV
Anti- 2-5 IU/l < 6% CV 2.6, 4.7% CV 2-5 IU/l < 8% CV 3.4, 5.6% CV
TSHR 5-20 IU/l < 3% CV 1.8, 1.4% CV 5-20 IU/l < 5% CV 1.9, 2% CV
20-40 IU/l < 4% CV 1% CV 20-40 IU/l < 6% CV 1.3% CV
Assay Specified intraassay internal evaluation Specified interassay precision internal evaluation
precision intraassay precision  interassay precision
CK-MB 0.3-5 ng/ml 0.15 ng/ml SD 0.02, 0.06 ng/ml 0.3-5 ng/ml 0.25 ng/ml SD 0.03, 0.1 ng/ml
>5-15 ng/ml ≤ 3% CV 1.3% CV >5-15 ng/ml ≤ 5% CV 2% CV
>15 ng/ml ≤ 5% CV 1.4, 1.2% CV >15 ng/ml ≤ 10% CV 2.6, 2.0% CV
Myoglobin 15-50 ng/ml < 8% CV 2.1% CV 15-50 ng/ml < 10% CV 2.6% CV
STAT 50-500 ng/ml < 5% CV 2.9, 1.3% CV 50-500 ng/ml < 6% CV 3.6, 1.6% CV
> 500 ng/ml < 8% CV 2.9, 3.4, 5.3, 1.9% CV > 500 ng/ml < 10% CV 3.8, 4.0, 6.7, 2.3% CV
proBNP II 50-100 pg/ml < 10% CV 2.1% CV 50-100 pg/ml < 13% CV 2.8% CV
>100-250 pg/ml < 5% CV 2.4% CV >100-250 pg/ml < 8% CV 2.6% CV
> 250 pg/ml < 5% CV 1.2, 1.4, 2.7% CV > 250 pg/ml < 5% CV 1.6, 2.1, 3.8% CV
< 50 pg/ml (not specified) 4.1% CV < 50 pg/ml (not specified) 4.6% CV
Troponin T 3 - < 25 ng/l < 1 ng/l SD 0.6 ng/l SD 3 - < 25 ng/l < 2 ng/l SD 1 ng/l SD
STAT hs 25-< 100 ng/l ≤ 5% CV 2.1, 1.1, 1.1% CV 25-< 100 ng/l ≤ 10% CV 3.6%, 4.4, 2.1% CV
> 100 ng/l ≤ 3% CV 1.5, 0.9, 0.8% CV > 100 ng/l ≤ 6% CV 2.2, 1.4, 1.3% CV
Troponin I 0.1-0.2 ng/ml ≤ 25% CV 0.1-0.2 ng/ml ≤ 40% CV
STAT 0.2-0.4 ng/ml ≤ 10% CV 9.1, 4.8% CV 0.2-0.4 ng/ml ≤ 20% CV 16, 8.9% CV
> 0.4 ng/ml ≤ 8% CV 3.3, 2.2, 4.2, 2.9% CV > 0.4 ng/ml ≤ 8% CV 5.9, 5.3, 3.2, 6.7, 3.6% CV
Digoxin < 2.2 ng/ml < 0.075 ng/ml SD 0.048, 0.045 ng/ml SD < 2.2 ng/ml < 0.15 ng/ml SD 0.07, 0.066 ng/ml SD
2.2-4 ng/ml < 3.5% CV 3.3% CV 2.2-4 ng/ml < 5.5% CV 4.1% CV
> 4 ng/ml < 5% CV >4 ng/ml < 7% CV
Digitoxin < 10 ng/ml < 8% CV 5.7% CV < 10 ng/ml < 10% CV 6.5% CV
10-40 ng/ml < 4% CV 2.6, 2.3% CV 10-40 ng/ml < 6% CV 3, 2.4% CV
> 40 ng/ml < 6% CV 1.8, 1.7% CV > 40 ng/ml < 8% CV 3, 2.6% CV
HCG 10-500 mIU/ml < 5% CV 2.2, 1.5, 1.3% CV 10-500 mIU/ml < 7% CV 3.1, 1.7, 1.3% CV
STAT 500-1000 mIU/ml < 3% CV 1.2% CV 500-1000 mIU/ml < 5% CV 1.4% CV
>1000 mIU/ml < 3% CV 1.2% CV >1000 mIU/ml < 5% CV 1.4% CV
HCG+β 2-5 mIU/ml ≤ 9% CV 4.9% CV 2-5 mIU/ml ≤ 10% CV 5.9% CV
5-10 mIU/ml ≤ 5% CV 1.9, 1.7% CV 5-10 mIU/ml ≤ 5% CV 2.9, 3.6, 2.9% CV
> 10 mIU/ml ≤ 4 % CV 3.3, 2.3, 1.3% CV > 10 mIU/ml ≤ 5 % CV 2.1, 2.7, 1.9% CV

precision measured precision  measured interassay
intraassay precision precision
ACTH 5-100 pg/ml < 5% CV 3.2, 1.3% CV 5-100 pg/ml < 8% CV 4.4, 1.8% CV
100-1000 pg/ml < 4% CV 1.1, 1.1% CV 100-1000 pg/ml < 6% CV 1.2, 1.1% CV
> 1000 pg/ml < 6% CV 1.2% CV > 1000 pg/ml < 8% CV 1.6% CV
Cortisol > 110 nmol/l < 6% CV 1.4, 1, 1.3, 1.3, 1.1% > 110 nmol/l < 8% CV 1.6, 1.4, 1.6, 1.5, 1.6% CV
CV
Cortisol < 17% CV 2.2, 2.3, 2.9, 2.3% CV < 20% CV 2.5, 3.2, 2.5, 1.8% CV
urine
Cortisol > 1.5 nmol/l < 6% CV 1.5, 4.0, 2.8, 2.7% CV > 1.5 nmol/l < 12% CV 7.2, 6.2, 4.9, 4.1% CV
saliva < 1.5 nmol/l (not specified) 6.1% CV < 1.5 nmol/l (not specified) 37.1% CV (0.93 nmol/l)
DHEAS 50-1000 µg/dl < 5% CV 2.2, 2.8, 2.8, 2.4, 1.7% 50-1000 µg/dl < 7% CV 2.6, 3.1, 3.6, 4.7, 2.4% CV
CV
Estradiol II 20-50 pg/ml ≤ 6% CV 5.7% CV 20-50 pg/ml ≤ 7% CV 6.3% CV
≥ 50-1000 pg/ml ≤ 4% CV 2.1, 3.7, 2.1% CV ≥ 50-1000 pg/ml ≤ 5% CV 3, 3.9, 2.3% CV
≥ 1000-3000 pg/ml ≤ 5% CV 1.6, 1.9, 2.2% CV ≥ 1000-3000 pg/ml ≤ 6% CV 2.4, 2.8, 3.6% CV
FSH 2-10 mIU/ml ≤ 4% CV 1.2 mIU/ml 1.8% CV 2-10 mIU/ml ≤ 6% CV 1.2 mIU/ml 5.3% CV
> 10-100 mIU/ml ≤ 3% CV 2.0, 1.4, 1.5% CV > 10-100 mIU/ml ≤ 4% CV 3.7, 2.9, 3.8% CV
> 100-200 mIU/ml ≤ 3% CV 1.8% CV > 100-200 mIU/ml ≤ 6% CV 5.1% CV
LH 2-10 mU/ml ≤ 5% CV 1.1% CV 2-10 mU/ml ≤ 6% CV 2.0% CV
> 10-100 mU/ml ≤ 3% CV 0.9, 0.8, 0.8% CV > 10-100 mU/ml ≤ 5% CV 1.9, 2.0, 2.0% CV
> 100-200 mU/ml ≤ 5% CV > 100-200 mU/ml ≤ 6% CV
< 2 mIU/ml (not specified) 1.8% CV < 2 mIU/ml (not specified) 5.2% CV

precision measured precision  measured interassay
intraassay precision precision
Progeste-rone > 1-5 ng/ml ≤ 5% CV 2.4% CV > 1-5 ng/ml ≤ 6% CV 5.4% CV
II > 5-25 ng/ml ≤ 5% CV 2.3, 1.5, 1.7% CV > 5-25 ng/ml ≤ 5% CV 4.6, 3.7, 4.1% CV
> 25-40 ng/ml ≤ 6% CV 2.7% CV > 25-40 ng/ml ≤ 8% CV 5.5% CV
Prolactin II 100-5000 µIU/ml ≤ 5% CV 4, 2.2, 2.8, 2, 3.3, 2.6% 100-5000 µIU/ml ≤ 6% CV 5, 3.6, 2.8, 3.7, 4.2, 3.4% CV
CV
SHBG 5-200 nmol/l < 4% CV 2.2, 2.1, 2.4, 2.8% CV 5-200 nmol/l < 6% CV 2.6, 2.7, 2.8, 5.6% CV
Testosterone 0.15 – 0.5 ng/ml ≤ 10% CV 2.8% CV 0.15 – 0.5 ng/ml ≤ 20% CV 3.8% CV
II 0.5-1 ng/ml ≤ 6% CV 2.1% CV 0.5-1 ng/ml ≤ 8% CV 3.2% CV
< 0.15 ng/ml (not specified) 4.7% CV < 0.15 ng/ml (not specified) 8.4% CV
C-Peptide 0.5-20 ng/ml ≤ 5% CV 4.2, 2.4, 4.7% CV 0.5-20 ng/ml ≤ 6% CV 3.0, 5.0, 1.8% CV
serum
C-Peptide 0.5-20 ng/ml ≤ 5% CV 1.6, 4.2, 2.9% CV 0.5-20 ng/ml ≤ 6% CV 4.2, 2.4, 1.8% CV
urine
Insulin 5-10 µU/ml < 5% CV 1.9% CV 5-10 µU/ml < 6% CV 2.6% CV
10-300 µU/ml < 4% CV 1.5, 1.7, 1.9, 2.2, 1.9% 10-300 µU/ml < 5% CV 2.5, 2.1, 2.8, 2.6, 2.3% CV
300-1000 µU/ml < 5% CV 2% CV 300-1000 µU/ml < 6% CV 2.5% CV
PlGF ≤ 50 pg/ml ≤ 4 pg/ml SD 0.28 pg/ml SD ≤ 50 pg/ml ≤ 5 pg/ml SD 0.45 pg/ml SD
≥ 50 pg/ml ≤ 8% CV 1, 0.8, 1% CV ≥ 50 pg/ml ≤ 10% CV 1.3, 1.4, 1.3% CV
≥ 200 pg/ml ≤ 6% CV 0.8% CV ≥ 200 pg/ml ≤ 8% CV 1.3% CV
≥ 1000 pg/ml ≤ 6% CV 0.8, 0.9% CV ≥ 1000 pg/ml ≤ 8% CV 1, 2% CV
sFlt-1 ≤ 25 pg/ml ≤ 2 pg/ml SD ≤ 25 pg/ml ≤ 3 pg/ml SD
≥ 25 pg/ml ≤ 8% CV 1.6% CV ≥ 25 pg/ml ≤ 12% CV 4.3% CV
≥ 200 pg/ml ≤ 7% CV 0.8, 1% CV ≥ 200 pg/ml ≤ 8% CV 2.3, 2.3% CV
≥ 10000 pg/ml ≤ 6% CV 1, 1.2, 1% CV ≥ 10000 pg/ml ≤ 7% CV 2.6, 2.9, 3.7% CV

precision intraassay precision precision  interassay precision
AFP 2-8 IU/ml ≤ 0.25 IU/ml SD 0.222 IU/ml SD 2-8 IU/ml ≤ 0.4 IU/ml SD 0.275 IU/ml SD
10-20 IU/ml ≤ 2.5% CV 2% CV 10-20 IU/ml ≤ 5% CV 3.1% CV
20-60 IU/ml ≤ 2% CV 1.5% CV 20-60 IU/ml ≤ 5% CV 2.4% CV
> 60 IU/ml ≤ 5% CV 2.2, 2% CV > 60 IU/ml ≤ 7% CV 2.7, 2.8% CV
CA 125 II 10 U/ml < 5% CV 3.3% CV 10 U/ml < 6% CV 4.2% CV
35 U/ml < 4% CV 1.9, 2.1% CV 35 U/ml < 4% CV 2.5, 3.1% CV
60-100 U/ml < 4% CV 2.1% CV 60-100 U/ml < 4% CV 2.5% CV
> 100 U/ml (not specified) 1.4% CV > 100 U/ml (not specified) 2.7% CV
CA 15-3 II 10-50 U/ml < 4% CV 1.6, 1.6% CV 10-200 U/ml ≤ 6% CV 3, 3, 2.5, 1.8, 2.5%
50-200 U/ml < 5%CV 2.7, 1.4, 1.9% CV CV
CA 19-9 30-1000 U/ml < 5% CV 2.9, 3.3, 2.9% CV 30 - 1000 U/ l < 9% CV 3.8, 3.8, 2.9% CV
< 30 U/ml (not specified) 4.4, 3.6% CV < 30 U/ml (not specified) 4.8, 4.1% CV
CA 72-4 2-100 U/ml ≤ 5% CV 2.1, 2.4, 2, 1.8% CV 2-100 U/ml ≤ 6% CV 3, 2.7, 2.6, 2% CV
100–250 U/ml ≤ 6% CV 2.1% CV 100–250 U/ml ≤ 8% CV 2.2% CV
CEA ≤ 2 ng/ml ≤ 0.1 ng/ml SD 0.11 ng/ml SD ≤ 2 ng/ml ≤ 0.15 ng/ml SD 0.18 ng/ml
4.6 ng/ml ≤ 3% CV 2.5% CV 4.6 ng/ml ≤ 6% CV 3.6% CV
10-50 ng/ml ≤ 5% CV 1.6, 1.7% CV 10-50 ng/ml ≤ 5% CV 2.3, 3% CV
50-500 ng/ml ≤ 8% CV 50-500 ng/ml ≤ 8% CV
> 500 ng/ml (not specified) 1.3% CV > 500 ng/ml (not specified) 2% CV
Cyfra 21-1 1-3 ng/ml ≤ 5% CV 2.1% CV 1-3 ng/ml ≤ 7% CV 4.7% CV

3.1-10 ng/ml ≤ 3% CV 2, 2% CV 3.1-10 ng/ml ≤ 5% CV 2.4, 3.3% CV
> 10 ng/ml ≤ 5% CV 1.6, 1.7% CV > 10 ng/ml ≤ 5% CV 2.1, 3.1% CV

HE4 < 30 pmol/l ≤ 3 pmol/l SD 0.5 pmol/l SD < 30 pmol/l ≤ 3 pmol/l SD 0.8 pmol/ l SD
30-150 pmol/l ≤ 5% CV 1.8% CV 30-150 pmol/l ≤ 7% CV 2.8, 2.6% CV
150-900 pmol/l ≤ 4% CV 1.5, 1.6% CV 150-900 pmol/l ≤ 6% CV 3% CV
>900-1500 pmol/l ≤ 5% CV 1.9% CV >900-1500 pmol/l ≤ 10% CV 3.2% CV
NSE 15-100 ng/ml < 3% CV 2.8, 2.3% CV 15-100 ng/ml < 5% CV 3.8, 4.4% CV
< 15 ng/ml (not specified) 2.1, 3.1, 2.1% CV < 15 ng/ml (not specified) 3, 4.4, 3.9% CV
free PSA 0.1-0.4 ng/ml ≤ 7% CV 1.9% CV 0.1-0.4 ng/ml ≤ 10% CV 4.5% CV
0.4-1 ng/ml ≤ 5% CV 1.7% CV 0.4-1 ng/ml ≤ 8% CV 4.7% CV
5-50 ng/ml ≤ 5% CV 1, 1.3% CV 5-50 ng/ml ≤ 8% CV 3.4, 4.2% CV
total PSA ≥ 0.1 ng/ml ≤ 7% CV 1.8% CV ≥ 0.1 ng/ml ≤ 10% CV 2.4% CV
1 ng/ml ≤ 2% CV 2.3% CV 1 ng/ml ≤ 5% CV 2.7% CV
4-10 ng/ml ≤ 2% CV 2.5% CV 4-10 ng/ml ≤ 5% CV 2.9% CV
S100 0.04-0.15 ng/ml ≤ 7% CV 2.1% CV 0.04-0.15 ng/ml ≤ 10% CV 2.8% CV
0.15-1.0 ng/ml ≤ 3% CV 1.8, 1.3% CV 0.15-1.0 ng/ml ≤ 5% CV 2.3, 2% CV
≥ 1.0 ng/ml ≤ 5% CV 1.4, 2% CV ≥ 1.0 ng/ml ≤ 7% CV 1.7, 2.4% CV
Free ≥ 1-15 IU/L ≤ 3.5% CV 0.95, 2.6, 2.8% CV ≥ 1-15 IU/L ≤ 6% CV 1.3, 2.6, 2.9% CV
ßhCG > 15-200 IU/L ≤ 3% CV 1.2, 1.1, 1.8% CV > 15-200 IU/L ≤ 5% CV 1.4, 1.2, 2.1% CV
PAPP-A 200-2000 mIU/ml < 3.5% CV 1.1, 2.4, 2.2% CV 200-2000 mIU/ml < 6% CV 1.1, 2.3, 2.2% CV
2000-5000 mIU/ml < 3% CV 1.6, 2.1% CV 2000-5000 mIU/ml < 5% CV 1.75, 2.3% CV
(> 5000 mIU/ml not specified) 1.7% CV (> 5000 mIU/ml not specified) 2% CV

B12 ≤ 300 pg/ml ≤22.5 pg/ml SD 18.8, 20.2 pg/ml SD ≤ 300 pg/ml ≤ 22.5 pg/ml SD 18.1, 22 pg/ml SD
> 300 pg/ml ≤5% CV 4.0, 3.1, 4.4, 3% CV > 300 pg/ml ≤ 8%CV 5.2, 3.4, 5.1, 3.7% CV
Ferritin 10-40 ng/ml < 7% CV 3.5, 1.8, 2.1% CV 10-40 ng/ml < 7% CV 4.4, 2.9, 3.2% CV
50-400 ng/ml < 4% CV 2.7, 1.8, 1.9% CV 50-400 ng/ml < 7% CV 3, 3.2, 2.2% CV
> 400 ng/ml (not specified) 2% CV > 400 ng/ml (not specified) 2.6% CV
Folate III ≤ 5 ng/ml <0.35 ng/ml SD 0.23, 0.24 ng/ml SD ≤ 5 ng/ml < 1 ng/ml SD 0.39, 0.45 ng/ml SD
> 5 ng/ml < 7% CV 5.7, 4.7 3.0, 4.3% CV > 5 ng/ml < 12% CV 6.4, 6.3, 7, 5% CV
RBC Folate na * na *
na not available at the moment

β- 0.03-0.5 ng/ml < 10% CV 3.4, 4.6, 1.8% CV 0.03-0.5 ng/ml < 10% CV 3.4, 4.7, 4.3% CV
CrossLaps/ 0.5-5 ng/ml < 3 % CV 1.6, 2.2, 1.0% CV 0.5-5 ng/ml < 6 % CV 1.9, 2.5, 1.6% CV
serum > 5 ng/ml < 5 % CV > 5 ng/ml < 6 % CV
hGH 0.7 ng/ml ≤ 0.04 ng/ml 0.012 ng/ml SD 0.7 ng/ml ≤ 0.04 ng/ml 0.003 ng/ml SD
deviation deviation 0.7, 1.0% CV
> 0.7 – 50 ng/ml ≤ 6% CV 1.7, 2.6% CV > 0.7 – 50 ng/ml ≤ 7% CV
N-MID 1-10 ng/ml < 0.5 ng/ml SD 0.3 ng/ml 1-10 ng/ml < 0.8 ng/ml SD 0.33 ng/ml
Osteocalcin 11-40 ng/ml < 5% CV 1.8, 4, 3.3, 2.5% CV 11-40 ng/ml < 7% CV 3.1, 6.5, 3.8, 3.5% CV
41-400 ng/ml < 3% CV 1.7, 1.4, 1.3, 1.2% CV 41-400 ng/ml < 5% CV 2.3, 1.8, 1.8, 1.7% CV
PTH 11-75 pg/ml < 7% CV 4.1, 2.2, 2.7, 1.6% CV 11-75 pg/ml < 9% CV 6.2, 4.1, 6.5, 3.9% CV
76-1000 pg/ml <5% CV 1.9, 1.5% CV 76-1000 pg/ml <6% CV 2.6, 3% CV
> 1000 pg/ml < 6% CV > 1000 pg/ml < 7% CV
PTH (1-84) < 25 pg/ml ≤ 1.5 pg/ml SD 0.98 pg/ml SD < 25 pg/ml ≤ 2 pg/ml SD 1.2 pg/ml SD
≥ 25 pg/ml ≤ 6% CV 1.6, 1.4% CV ≥ 25 pg/ml ≤ 8% CV 4.1, 3.1% SD
Total P1NP < 50 µg/l < 5% CV 3.5% CV < 50 µg/l < 7% CV 3.5% CV
50-500 µg/l < 4% CV 1.0, 0.8, 0.7% CV 50-500 µg/l < 5% CV 1.8, 2% CV
> 500 µg/l < 4% CV 1.3, 1.8, 2% CV > 500 µg/l < 6% CV 3.9, 2.6, 5.5% CV
Vitamin D 9-15 ng/ml ≤ 1.0 ng/ml SD 0.5, 0.7 ng/ml SD 9-15 ng/ml ≤ 1.7 ng/ml SD 1, 1.2 ng/ml SD
total > 15 ng/ml < 6.5% CV 5, 3, 2.5, 1.7% CV > 15 ng/ml < 11.5% CV 8.8, 5.5, 3.5, 2.2% CV
Elecsys® 2010 / cobas® e 411 Assays
Assay Specified intraassay precision internal evaluation Specified interassay precision internal evaluation
intraassay precision  interassay precision
IgE II 1-5 IU/ml < 9% CV - 1-5 IU/ml < 10% CV -
6-250 IU/ml < 6% CV 2, 4.1% CV 6-250 IU/ml < 7% CV 3.7, 5.1% CV
> 250 IU/ml < 5% CV 2.3, 2.4, 2.6, 2.4% CV > 250 IU/ml < 8% CV 4, 3.8, 3.9, 4% CV
Anti-CCP 10-25 U/ml ≤ 2.5 SD 0.6, 1% CV 10-25 U/ml ≤ 3.8 SD 3, 3.1% CV
25-200 U/ml ≤ 6% CV 1.4% CV 25-200 U/ml ≤ 8% CV 2.5% CV
200-1000 U/ml ≤ 8% CV 2.3% CV 200-1000 U/ml ≤ 10% CV 4.5% CV
BRAHMS 0.075-1 ng/ml ≤ 15% CV 1.3, 2.1% CV 0.075-1 ng/ml ≤ 20% CV 3.7, 4.2% CV
PCT > 0.1 ng/ml ≤ 10% CV 0.9, 2.1% CV > 0.1 ng/ml ≤ 15% CV 4, 4.9% CV
(< 0.075 ng/ml, not specified) 8.8% CV (< 0.075 ng/ml, not specified) 16.3% CV
IL-6 5-25 pg/ml rec. +/-5 pg/ml 5-25 pg/ml rec. +/-5 pg/ml
25-300 pg/ml ≤ 5% CV 2.3, 1.7, 2.5% CV 25-300 pg/ml ≤ 7% CV 5.4, 3.1, 3.2% CV
> 300 pg/ml ≤ 5% CV 2.6% CV > 300 pg/ml ≤ 7% CV 2.9% CV

Anti-HAV HS, neg < 3 IU/ml SD - HS, neg < 3 IU/ml SD -
HS, low pos < 7% CV 1.2% CV HS, low pos < 10% CV 4% CV
HS, positive < 5% CV 1.2% CV HS, positive < 10% CV 2.9% CV
Anti-HAV HS, neg ≤ 20% CV 2% CV HS, neg ≤ 20% CV 3.8% CV
IgM HS, low pos ≤ 7% CV 3.4% CV HS, low pos ≤ 10% CV 2.8% CV
HS, positive ≤ 5% CV 3.1% CV HS, positive ≤ 10% CV 5.4% CV
Anti-HBc HS, neg ≤ 7% CV 1.2% CV HS, neg ≤ 10% CV 1.4 % CV
HS, low pos ≤ 7% CV 3.9% CV HS, low pos ≤ 10% CV 1.1 % CV
HS, positive ≤ 7% CV 3.4% CV HS, positive ≤ 10% CV 1.3 % CV
PC a-HBc 1 ≤ 7% CV 1.9 % CV PC a-HBc 1 ≤ 10% CV 1.0 % CV
PC a-HBc 2 ≤ 7% CV 2.3% CV PC a-HBc 2 ≤ 10% CV 1.6 % CV
Anti-HBc HS, neg ≤ 5% CV 2.2% CV HS, neg ≤ 13% CV 2.8% CV
IgM HS, low pos ≤ 5% CV 3.5% CV HS, low pos ≤ 8% CV 1.8% CV
PC a-HBc IgM 1 ≤ 5% CV 1.7% CV PC a-HBc IgM 1 ≤ 10% CV 3.3% CV
PC a-HBc IgM 2 ≤ 7% CV 4.5% CV PC a-HBc IgM 2 ≤ 13% CV 3.6% CV
Anti-HBe HS, neg ≤ 5% CV 2.4% CV HS, neg ≤ 10% CV 2.6% CV
HS, low pos ≤ 3% CV 2.0% CV HS, low pos ≤ 5% CV 2.2% CV
PC a-HBe 1 ≤ 5% CV 2.1% CV PC a-HBe 1 ≤ 10% CV 2.0% CV
PC a-HBe 2 ≤ 3% CV 2.1 % CV PC a-HBe 2 ≤ 5% CV 2.5% CV
HS = human sera
- no information
HBeAg HS, neg ≤ 10% CV 4.0% CV HS, neg ≤ 10% CV 4.0, 1.7% CV
HS, low pos ≤ 5% CV HS, low pos -
HS, positive ≤ 5% CV 4.0, 2.8% CV HS, positive ≤ 5% CV 4.9% CV
PC HBeAg 1 ≤ 10% CV 6.6% CV PC HBeAg 1 ≤ 10% CV 4.5% CV
PC HBeAg 2 ≤ 5% CV 1.6% CV PC HBeAg 2 ≤ 5% CV 1.7% CV
Anti-HBs ≤ 5 IU/l ≤ 20% CV 3 IU/l 13.1% CV ≤ 5 IU/l ≤ 25% CV 3 IU/l 9.9% CV
5-10 IU/l ≤ 15% CV 5-10 IU/l ≤ 20% CV
10 IU/l ≤ 8% CV 10.7 IU/l 6.3% CV 10 IU/l ≤ 10% CV 10.7 IU/l 16.2% CV
10-1000 IU/l ≤ 5% CV 15.4, 498, 3.4-1.5% CV 10-1000 IU/l ≤ 8% CV 15.4, 498, 11-3.4% CV
603 IU/l 603 IU/l
Anti-HCV HS, neg ≤ 0.5 COI SD 0.01 COI SD HS, neg ≤ 0.5 COI SD 0.01 COI SD
HS, low pos ≤ 7 % CV 3.3, 1.2 % CV HS, low pos ≤ 10 % CV 3, 4.2% CV
HS, positive ≤ 8 % CV 1.1% CV HS, positive ≤ 10 % CV 3.5% CV
HBsAg II HS, neg ≤ 0.07 COI SD 0.03, 0.04 COI SD HS, neg≤ 0.7 COI SD 0.04, 0.04 COI SD
HS, low pos ≤ 7 % CV 2.2, 1.5% CV HS, low pos ≤ 10 % CV 5.7, 3.3% CV
HS, positive ≤ 7 % CV 3.9% CV HS, positive ≤ 10 % CV 1.1% CV
HBsAg II 0.05-5 IU/ml SD ≤ 0.5 IU/ml 0.13 IU/ml SD 0.05-5 IU/ml SD ≤ 0.6 IU/ml 0.17 IU/ml SD
quant. undiluted 0.6% CV undiluted 5.6% CV
5-130 IU/ml ≤ 10% CV undiluted 2.6% CV 5-130 IU/ml ≤ 12% CV undiluted 5.6& CV
5-13000 IU/ml ≤ 15% CV diluted 5-13000 IU/ml ≤ 17% CV diluted
HIV Ag HS, neg - 5.2% CV HS, neg - 7.1% CV
HS, low pos ≤ 5 % CV 2.7% CV HS, low pos - 3.7% CV
HS, positive - 2.6% CV HS, positive - 4.1% CV
PC HIV Ag 1 ≤ 10 % CV 6.6 % CV PC HIV Ag 1 ≤ 20 % CV 5.9% CV
PC HIV Ag 2 ≤ 5 % CV 2.0 % CV PC HIV Ag 2 ≤ 10 % CV 5.0% CV
HS = human sera - no information
HIV combi HS neg: ≤ 10 % CV 3.4% CV HS neg: ≤ 15% CV 10.1% CV
HS, pos. # ≤ 6 % CV 1.2, 1, 0.9% CV HS, pos. # ≤ 10 % CV 3.6, 3.9, 3.6% CV
PC HIV com. 1 ≤ 10 % CV na 5.8% CV PC HIV com. 1 ≤ 20% CV 7.9% CV
PC HIV com. 2 ≤ 5% CV 1% CV PC HIV com. 2 ≤ 10% CV 1.5% CV
PC HIV com. 3 ≤ 5% CV 1.5% CV PC HIV com. 3 - 2.8% CV
HIV combi HS neg (COI ≤ 0.6): SD ≤ 0.06 0.026 COI SD HS neg (COI ≤ 0.6): SD ≤ 0.09 0.031 COI SD
PT Anti-HIV-1 pos. ≤ 6 % CV 0.9% CV Anti-HIV-1 pos. ≤ 10 % CV 1.4% CV
Anti-HIV-2 pos. ≤ 6 % CV 0.9% CV Anti-HIV-2 pos. ≤ 10 % CV 1.5% CV
HIV Ag pos. 3 ≤ 6% CV 0.9% CV HIV Ag pos. 3 ≤ 10% CV 1.8% CV
CMV IgG 0.5-2.0 U/ml ≤ 10 % CV 0.9, 1.2, 1.5% CV 0.5-2.0 U/ml ≤ 12 % CV 3.2, 2.6, 3.3% CV
> 2.0 U/ml ≤ 7 % CV 0.7, 1.5, 1.4% CV > 2.0 U/ml ≤ 10 % CV 3.9, 3.3, 3.6% CV
CMV IgG < 10 Avi% ± 2 Avi% SD 0.04 Avi% SD < 10 Avi% ± 3 Avi% SD 0.1 AVI% SD
Avidity 10-100% Avi ≤ 8% CV 1, 2.6, 1.5, 3.1% Avi 10-100% Avi ≤ 8% CV 2.0, 3.4, 2.6% AVI%
CMV IGM < 0.6 COI ≤ 0.06 COI SD 0.003, 0.002 COI SD < 0.6 COI ≤ 0.06 COI SD 0.005, 0.004 COI SD
> 0.6 COI ≤ 7% CV 1.5, 1.8% CV > 0.6 COI ≤ 7% CV 5.3, 3.4, 3.1% CV
HSV-1 IgG ≤ 0.8 COI ≤ 0.1 SD 0.003, 0.001, 0.006 COI SD ≤ 0.8 COI ≤ 0.15 SD 0.006, 0.001, 0.012 COI SD
> 0.8-2.0 COI ≤ 6% CV 1, 1.3% CV > 0.8-2.0 COI ≤ 8% CV 2.9, 2.8% CV
> 2 COI ≤ 8% CV 1, 1.3% CV > 2 COI ≤ 10% CV 2.5, 2.8% CV
HSV-2 IgG ≤ 0.8 COI ≤ 0.1 SD 0.005, 0.004 COI SD ≤ 0.8 COI ≤ 0.15 SD 0.01, 0.007 COI SD
> 0.8-2.0 COI ≤ 6% CV 1.2, 1.2% CV > 0.8-2.0 COI ≤ 8% CV 2.8% CV
> 2 COI ≤ 8% CV 1.6, 1.6% CV > 2 COI ≤ 10% CV 3.3, 3.6% CV
Rubella IgG < 5 IU/ml < 1 IU/ml SD 0.075 IU/ml SD < 5 IU/ml < 1.1 IU/ml SD 0.074 IU/ml SD
> 5 IU/ml < 10% CV 1.9, 2.5, 1.6% CV > 5 IU/ml < 12% CV 3.8, 3.4, 3.6% CV
Rubella IgM HS neg: ≤ 7 % CV 2.4% CV HS neg: ≤ 10 % CV 3% CV
HS, pos. ≤ 7 % CV 1.2, 1% CV HS, pos. ≤ 10 % CV 1.9, 4.1% CV
PC Rub. IgM 1 ≤ 7 % CV 1.4% CV PC Rub. IgM 1 ≤ 10 % CV 4.1% CV
PC Rub. IgM 2 ≤ 7 % CV 1.1% CV PC Rub. IgM 2 ≤ 10 % CV 4.1% CV
# HS low pos/pos.: for anti-HIV 1, anti-HIV 2, HIV Ag determined (separate available in package insert)
Toxo IgG HS neg: ≤ 7 % CV HS neg: ≤ 10 % CV
HS, pos. ≤ 7 % CV 1.5, 1.3 % CV HS, pos. ≤ 10 % CV 4.2, 5.3% CV
PC Toxo IgG 1 ≤ 7 % CV 1.6 % CV PC Toxo IgG 1 ≤ 10 % CV 5.7% CV
PC Toxo IgG 2 ≤ 7 % CV 2.1% CV PC Toxo IgG 2 ≤ 10 % CV 3.0% CV
Toxo IgM HS neg: ≤ 7 % CV HS neg: ≤ 10 % CV
HS, pos. ≤ 7 % CV 1.9, 1.6% CV HS, pos. ≤ 10 % CV 4, 3.6 % CV
PC Toxo IgM 1 ≤ 7 % CV 2.5% CV PC Toxo IgM 1 ≤ 10 % CV 2.7% CV
PC Toxo IgM 2 ≤ 7 % CV 1.6% CV PC Toxo IgM 2 ≤ 10 % CV 3% CV
# HS low pos/pos.: for anti-HIV 1, anti-HIV 2, HIV Ag determined (separate available in package insert)
Elecsys 2010 ® Calibrators

Assay Calibra- Calibrator Calibrator Calibrator Calibrator Calibrator Freezing Calibrator Calibrator
Cat.no. tion target stability stability stability possible material volume
Calibrator frequence Cal 1/ unopened opended on board per bottle/
Cal 2 2-8°C 2-8°C 20-25°C lyophilized ready- Pipetting
to- use volume
FT3 ° as ≈ 2/40 Expiry date 8 weeks 5 hours Y - lyo. human 1 ml
03051994 required, pmol/l serum with 15 μl
e.g. control ≈ 1.3/26 added FT3
not within pg/ml
range
FT4 ° every 1 ≈ 10/45 Expiry date 12 weeks 5 hours Y - buffer/protein 1 ml
11731661 month pmol/l matrix with 15 μl
(same lot) ≈ 0.78/3.5 added L-
° every ng/dl thyroxine
week
(same RP)
T3 ≈ 1.25/8.5 Expiry date 8 weeks 5 hours Y - lyo. human 1 ml
11731548 nmol/l, serum with 30 μl
≈ 0.8/5.5 added T3
ng/ml
T4 ≈ 50/230 Expiry date 12 weeks 5 hours Y - buffer/protein 1 ml
12017717 nmol/l, matrix with 15 μl
≈ 3.9/17.9 added L-
µg/dl thyroxine
TSH ≈ 0/1.5 Expiry date 12 weeks 5 hours Y - equine serum 1.3 ml
11741483 µIU/ml matrix with 50 μl
added rec.
TSH
- no information

Assay Calibra- Calibrator Calibrator Calibrator Calibrator Calibrator Freezing Calibrator Calibrator
Cat.no. tion target stability stability stability possible material volume
Calibrator frequence Cal 1/ unopened opended on board per bottle/
Cal 2 2-8°C 2-8°C 20-25°C lyophilized ready- Pipetting
to- use volume
T-uptake ° as ≈ 0.5/1.3 Expiry date 12 weeks 5 hours Y - buffer/protein/ 1 ml
11731505 required TBI TBG matrix 15 μl
e.g. control with added L-
not within thyrox.
TG range ≈ 4/850 Expiry date 3 days 5 hours Y 1x lyo. human 1 ml
11820940 ° every 1 ng/ml (-20°C / 3 serum with 20 μl
month month) added tg
Anti-TG (same lot) ≈ 40/3250 Expiry date 6 weeks 5 hours Y not human serum 1.3 ml
06368603 ° every IU/ml possible matrix with 10 µl
week added human
(same RP) anti-TG
antibodies
Anti-TPO  ≈ 35/350 Expiry date 6 weeks 5 hours Y not human serum 1.5 ml
06472931 IU/ml possible matrix with 20 µl
added polycl.
anti-TPO
Anti-TSHR  ≈ 1/25 IU/l expiry date - 3 hours Y 1x human serum 2 ml
(-20°C / 3 matrix with 50 µl
month) added Anti-
TSHR
antibodies
- no information  calibrators are part of the test kit
 Calibration must be performed with ° every new reagent kit, ° daily (when using the same reagent kit on the analyzer), ° as required e.g. control not
within the range.
Assay Calibration Calibrator Calibrator Calibrator Calibrator Calibrator Freezing Calibrator Calibrator
Cat.no. frequence target stability stability stability possible material volume
Calibrator Cal 1/Cal unopened opended on board per bottle/
2 2-8°C 2-8°C 20-25°C lyophilized Pipetting
ready- volume
to-
use
CK-MB ° as required, ≈ 1.5/25 Expiry date 2 weeks 5 hours Y 1x lyo. human 1 ml
05957664 e.g. control ng/ml (-20°C / 3 serum with 15 μl
(9 min)/ not within month) added CK-
05957656 range MB
(18 min)
° every 1
Myoglobin month (same ≈ 35/1200 Expiry date 12 weeks 5 hours Y - buffer/ 1 ml
11820893 lot), ng/ml protein 15 µl
(9 min)/ ° every week matrix with
12178222 (same RP) added
(18 min) myoglobin
proBNP II ≈ 140/2700 Expiry date 2 weeks 5 hours Y 1x equine 1 ml
04842472 pg/ml (-20°C / 3 serum 15 µl
≈ 16.6/320 month) matrix with
pmol/l added
proBNP
Troponin T ≈ 18/4200 Expiry date 2 weeks 5 hours Y 1x lyo. rec. 1 ml
hs ng/l (-20°C / 3 human 50 μl
05092736 month) serum with
(9 min)/ added
05092752 Troponin T
(18 min)
- no information
Assay Calibratio Calibrator Calibrator Calibrator Calibrator Calibrator Freezing Calibrator Calibrator
Cat.no. n target stability stability stability possible material volume
Calibrator frequence Cal 1/Cal unopened opended on board per bottle/
2 2-8°C 2-8°C 20-25°C lyophilized ready- Pipetting
to- use volume
Troponin I ° as ≈ 0.4/30 Expiry date 4 days 5 hours Y 3 months human 1 ml
STAT required, ng/ml, (freeze serum 30 µl
05094801 e.g. control only once) matrix with
not within added TNI
range
Digoxin ° every 1 ≈ 0.61/3.61 Expiry date 12 weeks 5 hours Y - bovine 1.5 ml
11820907 month ng/ml, serum 10 µl
(same lot), ≈ 0.78/4.62 matrix with
° every nmol/l added
week Digoxin
(same RP)
Digitoxin ≈ 5.00/60 Expiry date 12 weeks 5 hours Y - lyo. human 1 ml
03002667 ng/ml, serum with 15 µl
≈ 6.55/79 added
nmol/l Digitoxin
HCG STAT ≈ 10/5000 Expiry date 12 weeks 5 hours Y - lyo. human 1 ml
03303071 mIU/ml serum with 10 μl
added HCG
HCG+β ≈ 1.5/2000 Expiry date 12 weeks 5 hours Y - lyo. human 1 ml
03302652 mIU/ml serum with 10 µl
added HCG
- no information

Cat.no. frequence target stability stability stability possible material volume per
Calibra- Cal 1/Cal unopened opended on board bottle/
tor 2 2-8°C 2-8°C 20-25°C lyophilized ready- Pip. Vol.
to- use
ACTH ° as required, ≈ 15/120 Expiry date - use Y 7 lyo. equine 1 ml
03255760 e.g. control pg/ml immediately serum with 50 µl
not within and only added ACTH
range once
Cortisol ° every 1 ≈ 12.5/1000 Expiry date - use only Y 1x lyo. human 1 ml
11875124 month nmol/l once (-20°C / 3 serum with 20 µl
(same lot), ≈ 0.45/36 month) added
° every µg/dl Cortisol
DHEA-S week ≈ 0.14/20 Expiry date - use only Y 1x lyo. human 1 ml
03000095 (same RP) µmol/l once (-20°C / 3 serum with 15 µl
≈ 5/750 month) added
µg/dl DHEA-S
Estradiol ≈ 73/11000 Expiry date - use only Y 1x lyo. human 1 ml
II pmol/l, once (-20°C / 3 serum matrix 35 µl
03064921 ≈ 20/3000 month) with added
pg/ml Estradiol
FSH II ≈ 1/55 Expiry date - use only Y 1x lyo. equine 1 ml
03032680 mIU/ml once (-20°C / 3 serum 40 µl
month) matrix with
added
human FSH
- no information

Calibrator Cal 1/Cal unopened opended on board per
2 2-8°C 2-8°C 20-25°C lyophilized ready- bottle/
to- use Pip. Vol.
LH II ° as required, ≈ 1/45 Expiry date - use only Y 1x lyo. human 1 ml
03561097 e.g. control mIU/ml once (-20°C / 3 serum matrix 20 µl
not within month) with added LH
range
° every 1
Progesteron month ≈ 0.6/169 Expiry date 12 weeks use only Y - lyo. human 1 ml
e II (same lot), nmol/l once serum with 30 µl
12145391 ° every ≈ 0.2/53 added
week ng/ml Progesterone
(same RP)
Prolactin II ≈ 2/2000 Expiry date - use only Y 1x lyo. buffer/prot. 1 ml
03277356 µIU/ml, once (-20°C / 3 matrix with 10 µl
≈ 0.09/94 month) added
ng/ml recombinant
Prolactin
SHBG ≈ 0/40 Expiry date - use only Y 1x lyo. equine 1 ml
03052028 nmol/l once (-20°C / serum (Cal 1) 10 µl
2 month) and human
serum (Cal 2)
Testoste- < 1.4/≈ 40 Expiry date - use only Y 1x lyo. human 1 ml
rone II nmol/l, once (-20°C / serum with 20 µl
05202230 < 0.4/≈ 3 month) added
11.5 ng/ml Testosterone
- no information

2 2-8°C 2-8°C 20-25°C lyophilized ready- Pip. Vol.
to- use
C-Peptide ° as required, ≈ Expiry date - use only Y 1x lyo. equine 1 ml
03184919 e.g. control 0.167/6.67 once (-20°C / 3 serum matrix 20 µl
not within nmol/l month) with added
range ≈ 0.5/20 C-peptide
° every 1 ng/ml
Insulin month ≈ 5/300 Expiry date - use only Y 1x lyo. bovine 1 ml
12017504 (same lot), µU/ml once (-20°C / 3 serum with 20 µl
° every ≈ 35/2080 month) added insulin
week pmol/l
(same RP)
PlGF ≈ 5/1200 Expiry date - 2 hours Y 1x Mutein, 1 ml
05144701 pg/ml (-20°C / 1 human, rec. 50 µl
month) from E.coli
sFlt-1 ≈ 5/15000 Expiry date - 3 hours Y 1x Fragment, 1 ml
05109531 pg/ml (-20°C / 1 human, rec. 20 µl
month)
Calibrator Cal 1/Cal unopened opended on board bottle/
to- use volume
AFP II ° as required, ≈ 5/50 Expiry date 6 weeks 5 hours Y 1x lyo. human 1 ml
04487761 e.g. control IU/ml, (-20°C / serum with 10 μl
not within ≈ 6/60 6 weeks) added human
range ng/ml AFP
CA 125 II ° every 1 ≈ 35/500 Expiry date 12 weeks 5 hours Y - human serum 1 ml
11776240 month U/ml with added 40 µl
(same lot), human CA 125
° every week
(same RP)
CA 15-3 II ≈ 15/100 Expiry date 12 weeks 5 hours Y - human serum 1 ml
03045846 U/ml with added 20 µl
human CA 15-
3
CA 19-9 ≈ 20/250 Expiry date 4 weeks 5 hours Y 1x lyo. human 1 ml
11776215 U/ml (-20°C / serum with 10 µl
2 month) added human
CA 19-9
CA 72-4 ≈ 1/70 U/ml Expiry date 6 weeks 5 hours Y - lyo. human 1 ml
11776274 serum with 30 µl
added human
CA 72-4
- no information
Assay Calibration Calibrator Calibrator Calibrator Calibrator Calibrator Freezing Calibrator Calibrato
Cat.no. frequence target stability stability stability possible material r volume
Calibrator Cal 1/Cal unopened opended on board per
2 2-8°C 2-8°C 20-25°C lyophilized ready- bottle/
to- use Pipetting
volume
CEA ° as required, ≈ 5/50 Expiry date 12 weeks 5 hours Y - buffer/protein 1 ml
11731645 e.g. control ng/ml matrix with 10 μl
not within added CEA
range
Cyfra ° every 1 ≈ 0/50 Expiry date 8 weeks 5 hours Y - lyo. human 1 ml
21-1 month ng/ml serum with 20 µl
11820974 (same lot), added
° every week cytokeratin
(same RP)
NSE ≈ 0.5/50 Expiry date 6 weeks 3 hours Y - buffer/protein 1 ml
12133121 ng/ml matrix with 20 µl
added NSE
free PSA ≈ 0.1/20 Expiry date 12 weeks 5 hours Y - buffer/protein 1 ml
03289796 ng/ml matrix with 20 µl
added
human PSA
total PSA II ≈ 0/60 Expiry date 6 weeks 5 hours Y - - human 1 ml
04485220 ng/ml serum matrix 20 μl
with added
human PSA
- no information
Elecsys® 2010 Calibrators
Calibra- Cal 1/Cal 2 unopened opended on board per
tor 2-8°C 2-8°C 20-25°C lyophilized ready- bottle/
to- use Pipetting
volume
S100 ° as required, ≈ 0.2/2.0 Expiry date 4 weeks 5 hours Y 3 month lyo. human 1 ml
03289834 e.g. control µg/l (freeze serum with 20 µl
not within only once) added
range S100B(ββ)
antigen
Free ° every 1 ≈ 1/64 IU/L Expiry date 6 weeks 5 hours Y 3 month lyo. human 1 ml
ß-hCG month (freeze serum with 10 µl
04854080 (same lot), only once) added free
° every week ßhCG
(same RP)
PAPP-A ≈ 75/2500 Expiry date - 5 hours Y 3 month lyo. hzman 1 ml
04854191 mIU/L (freeze serum matrix 15 µl
only once) added PAPP-
A
Calibra- Cal 1/Cal 2 unopened opended on board per bottle/
tor 2-8°C 2-8°C 20-25°C lyophilized Pipetting
ready- volume
to- use
Vitamin ° as required, ≈ 100/1500 Expiry date 3 days use only Y 3 months human 1 ml
B12 II e.g. control pg/ml, once (freeze serum with 15 µl
04572459 not within ≈ 74/1107 only added B12
range pmol/l once)
Ferritin ° every 1 ≈ 10/300 Expiry date 12 weeks 5 hours Y - human 1 ml
03737586 month ng/ml serum with 10 µl
(same lot), added
° every week Ferritin
Folate III# (same RP) ≈ 4/17 ng/ml Expiry date 3 days use only Y 3 months lyo. human 1 ml
04476441 ≈ 9.1/38.5 once (freeze serum 25 µl
nmol/l only albumin
once) matrix with
added
Folate
- no information
# reconstitution time 30 minutes
to- use volume
β- ° as required, ≈ 0.05/2.0 Expiry date 12 weeks 5 hours Y - β-CTx (synthetic 1 ml
CrossLaps/ e.g. control ng/ml peptide) in an 50 µl
serum not within ≈ 50/2000 equine matrix
11972316 range pg/ml
every 1
N-MID ° month (same ≈ 0/280 Expiry date 1 week 5 hours Y 1x human serum 1 ml
Osteocalcin lot), ng/ml (-20°C / 3 with added 20 µl
11972111 ° every week month) Osteocalcin
(same RP) (synthetic
° after seven peptide, human
days (20- sequence)
25°C)
PTH ≈ 0.05/4500 Expiry date 2 weeks 5 hours Y 1x PTH (synthetic 1 ml
04894138 (9 pg/ml (-20°C / 3 peptide, human 50 µl
min) ≈ 0.005/477 month) sequence) in
11972219 pmol/l human serum
(18 min) matrix
PTH (1-84) ≈ 0.1/420 Expiry date 5 days 5 hours Y 1x PTH (synthetic 1 ml
05608554 pg/ml (-20°C / 90 peptide, human 50 µl
≈ 0.01/42 days) sequence) in
pmol/l human serum
matrix
Total P1NP ≈ 25/850 µg/l Expiry date 1 week up to 24 Y 5x P1NP (human) 1 ml
03141080 hours (-20°C / 3 in human serum 20 µl
month matrix
Vitamin D ≈ 2/45 ng/ml expiry date 120 hours up to 5 hours Y 1x 25-OH Vitamin 1 ml
total ≈ 5/113 (-20°C / 28 D3 in human 15 µl
05894921 nmol/l days) serum matrix
Elecsys® 2010 Calibrators
Calibrator Cal 1/Cal 2 unopened opended on board bottle/
2-8°C 2-8°C 20-25°C lyophilized ready- Pipetting
to- use volume
IgE ° as ≈ 1/100 IU/ml Expiry date 12 weeks 5 hours Y - equine 1 ml
11930427 required, ≈ 2.4/240 serum 10 µl
e.g. control ng/ml matrix with
not within added
range human IgE
Anti-CCP ° every 1 ≈ 20 / 200 Expiry date - 2 hours Y 4 weeks Anti-CCP 1 ml
month U/ml (freeze antibodies 15 µl
(same lot), only in human
° every once) serum
week matrix
BRAHMS (same RP) ≈ 0.1 / 54 Expiry date - 2 hours Y 3 months PCT in 4 ml
PCT ng/ml (freeze human 30 µl
only serum
once) matrix
IL-6 ≈ 18 / 700 Expiry date - 5 hours Y 3 months IL-6 (human, 2 ml
pg/ml (freeze rec.) 30 µl
only once)
 calibrators are part of the test kit
- no information

For all Infectious disease assays: Calibrators are part of the test kit; lot number of RackPack and calibrators are identical
Calibrator frequence target stability stability stability possible material volume
are within range unopened opended on board per bottle/
the testkit Qual.: counts 2-8°C 2-8°C 20-25°C lyophilized ready- Pipetting
Quant.: units
to- use volume
Anti-HAV ° as required, na Expiry date 6 weeks 5 hours Y - Cal1: neg. calibrator, 1 ml
e.g. control human serum 50 µl
not within Cal2: pos. Calibrator,
range Anti-HAV (human) ≈
° every 1 46 IU/l in human
serum
month
Anti-HAV IgM (same lot), na Expiry date 8 weeks 5 hours Y - Cal1: neg. calibrator, 0.67 ml
° every week human serum 10 µl
(same RP) Cal2: pos.
calibrator,Anti-HAV
IgM (human) ca. 5
U/ml in human serum
Anti-HBc Cal1: 42000- Expiry date 8 weeks 5 hours Y - Cal1: neg. calibrator, 1 ml
250000 human serum 40 µl
Cal2: 100- Cal2: pos.
3000 calibrator,Anti-HBc
(human) > 8 PEI
units/ml in human
serum
Anti-HBc IgM Cal1: 600- Expiry date 8 weeks 5 hours Y - Cal1: neg. calibrator, 1 ml
Cal2: 24000- Cal2: pos.
150000 calibrator,Anti-HBc
(human) > 100 PEI
U/ml in human serum

the testkit Qual.: 2-8°C 2-8°C 20-25°C lyophilized ready- Pipetting
counts to- use volume
Quant.:
units
Anti-HBe ° as required, Cal1: Expiry date 8 weeks 5 hours Y - Cal1: neg. 1 ml
e.g. control 300000- calibrator, 35µl
not within 1500000 human serum
range Cal2: 1000- Cal2: pos.
° every 1 6000 calibrator,Anti-
month HBe (human) >
(same lot), 3 PEI U/ml in
° every week human serum
HBeAg (same RP) Cal1: 400- Expiry date 8 weeks 5 hours Y - Cal1: neg. cal., 1 ml
Cal2: Cal2: pos.
20000- calibratorHBeAg
100000 (E.coli, rDNA)
approx. 5 U/ml
[PEI units] in
HEPES
Anti-HBs Cal1: 4-15 Expiry date 8 weeks 5 hours Y - Cal1: Anti-HBs 1.3 ml
IU/l (human) in 40 µl
Cal2: 350- human serum
600 IU/l Cal2: Anti-HBs
(human) in
human serum

Calibra- frequence target stability stability stability possible material volume
tor are range unopened opended on board per bottle/
within Qual.: 2-8°C 2-8°C 20-25°C lyophilized ready- Pipetting
the counts to- use volume
testkit Quant.:
units
HBsAg II ° as required, Cal1: 600- Expiry date 8 weeks 5 hours Y - Cal1: neg. 1.3 ml
e.g. control not 1700 calibrator, human
within range Cal2: 3000- serum 50µl
° every 1 month 11000 Cal2: pos.
(same lot) calibrator, HBsAg
° every week 0.5 IU/ml in human
(same RP) serum
HBsAg II ≈ 0 / 0.5 IU/ml Expiry date 8 weeks 5 hours Y - Cal1: neg. 1.3 ml
quant calibrator, human
serum 50µl
Cal2: pos.
calibrator, HBsAg
0.5 IU/ml in human
serum
Anti-HCV  Cal1: 350- Expiry date 8 weeks 5 hours Y - Cal1: neg. cal. , 1.3 ml
Cal2: 10000- Cal2: pos.
38000 calibrator, anti HCV
- no information  Calibration must be performed with every new reagent kit

Calibra- frequence target stability stability stability possible material volume
tor are range unopened opended on board per bottle/
within Qual.: 2-8°C 2-8°C 20-25°C lyophilized ready- Pipetting
the counts to- use volume
testkit Quant.:
units
HIV Ag ° as required, Cal1: 600- Expiry date 4 weeks 5 hours Y - Cal1: neg. cal. , 1 ml
e.g. control 1400 human serum 50 µl
not within Cal2: 18000- Cal2: pos.
range 55000 calibrator,HIV
° every 1 p24-antigen
month (same (E.coli, rDNA) 240
lot) pg/ml in acetate
° every week buffer
HIV combi (same RP) Cal1: 1600- Expiry date 8 weeks 5 hours Y - Cal1: neg. cal., 1 ml
Cal2: 24 000 Cal2: pos.
– 110 000 calibrator, human
serum, anti-HIV
positive
HIV combi Cal1:1200- Expiry date 12 weeks 5 hours Y Do not Cal1: neg. cal., 1 ml
PT 5000 freeze. human serum 40 µl
Cal2: 17000- Cal2: pos.
75000 calibrator, human
serum Anti-HIV-1
positive
- no information
Elecsys® 2010 / cobas e 411 Calibrators
For all Torch assays: Calibrators are part of the test kit; lot number of RackPack and calibrators are identical
Calibra- frequence target stability stability stability possible material volume per
tor are range unopened opended on board bottle/
within the Qual.: 2-8°C 2-8°C 20-25°C lyophilized ready- Pipetting
testkit counts to- use volume
Quant.:
units
CMV IgG ° as required, e.g. Cal1: neg. expiry date 8 weeks 5 hours Y - Cal1: neg. 1 ml
control not within Cal2: ~ 40 calibrator, human 20 µl
range U/ml serum (hs)
° every 1 month Cal2: pos.
(same calibrator, hs
CMV IgG lot) Cal1: neg. expiry date 8 weeks 5 hours Y - Cal1: neg. 1 ml
Avidity ° every week Cal2: ~ 40 calibrator, human 20 µl
(same RP) U/ml serum (hs)
Cal2: pos.
calibrator, hs
CMV IgM Cal1: neg. expiry date 4 weeks 5 hours Y - Cal1: neg. 1 ml
Cal2: pos. calibrator, hs 10 µl
Cal2: pos.
calibrator, hs
HSV-1 IgG Cal1: 600- expiry date 28 days 5 hours Y 1 freeze / Cal1: neg. 1 ml
20000 thaw cycle calibrator, hs 20 µl
Cal2: 35000- possible Cal2: pos.
500000 calibrator, hs
HSV-2 IgG Cal1: 600- expiry date 28 days 5 hours Y 1 freeze / Cal1: neg. 1 ml
6500 thaw cycle calibrator, hs 20 µl
Cal2: 28000 - possible Cal2: pos.
300000 calibrator, hs

For all Torch assays: Calibrators are part of the test kit; lot number of RackPack and calibrators are identical
the testkit Qual.: 2-8°C 2-8°C 20-25°C lyophilized ready- Pipetting
counts to- use volume
Quant.:
units
Rubella IgG ° as required, Cal1: neg. expiry date 8 weeks 5 hours Y - Cal1: neg. 1 ml
e.g. control Cal2: ~ 400 calibrator, 10 µl
not within IU/ml human serum
range (hs)
° every 1 Cal2: pos.
Month (same calibrator, hs
Rubella IgM lot) Cal1: neg. expiry date 4 weeks 5 hours Y - Cal1: neg. 1 ml
° every week Cal2: ~ 700 calibrator, hs 10 µl
(same RP) U/ml Cal2: pos.
calibrator, hs
Toxo IgG Cal1: neg. expiry date 8 weeks 5 hours Y - Cal1: neg. 1 ml
Cal2: ~ 100 calibrator, hs 10 µl
IU/ml Cal2: pos.
calibrator, hs
Toxo IgM Cal1: neg. expiry date 4 weeks 5 hours Y - Cal1: neg. 0.67 ml
Cal2: ~ 130 calibrator, hs 10 µl
U/ml Cal2: pos.
calibrator, hs
Elecsys 2010 ® Controls
Control ready- lyo- Package Concen- Volume Stability Stability Stability Stability Control
Cat.no. to-use philized content tration per unopened opened or freezend 20-25°C/ materia
range bottle 2-8°C reconstitu- on board l
ted
2-8°C
PreciControl Y 2 levels, * 3 ml Expiry date 3 days one month -/ human
Universal each level (only freeze 5 hours serum
11731416 two bottles once) # matrix
PreciControl Y 2 levels, * 2 ml Expiry date 3 days three month -/ human
Cardiac II each level (only freeze 3 hours serum
04917049 two bottles once) matrix
after thawing
use only once
PreciControl Y 2 levels, * 2 ml Expiry date 4 days three month -/ rec
Troponin each level (freeze only 5 hours human
05095107 two bottles once) serum
after thawing matrix
use only once
PreciControl Y 1 level, ≈ 0.2 2 ml Expiry date 12 weeks - -/ equine
TSH four µIU/ml 5 hours serum
11776479 bottles matrix
- no information
# Stability of insulin in the reconstituted control serum: on the analyzers at 20-25°C and at 20-25°C: up to 5 hours/at –20°C 1 month (only freeze
once)
Control ready- lyo- Package Concen- Volume Stability Stability Stability Stability Control
Cat.no. to-use phili- content tration per unopened opened or freezend 20-25°C/ material
zed range bottle 2-8°C reconsti- on board
tuted
2-8°C
PreciControl Y 2 levels, * 3 ml Expiry date 2 weeks one month 24 hours/ human
Tumormarker each level (only freeze 5 hours serum
PreciControl Y 2 levels, * 3 ml Expiry date 72 hours 31 days 5 hours/ human
Varia$ each level (only freeze 5 hours serum
- no information
$ controls not barcoded for cobas e 602
Control ready- lyo- Package Concen- Volum Stability Stability Stability Stability Control
Cat.no. to-use philize content tration e per unopened opened or freezend 20-25°C/ material
d range bottle 2-8°C reconsti- on
tuted board
2-8°C
PreciControl Y 2 levels, * 2 ml Expiry date 72 hours 31 days -/ equine serum
Multimarker each level (freeze only up to 5 matrix
05341787 three bottles once) hours
PreciControl Y 2 levels, ≈ 4/16 IU/l 2ml Expiry date - three months 3 hours / 3 human serum
ThyroAB each level Anti-TSHR (only freeze hours matrix
05042666 one bottle once)
PreciControl Y 3 levels, * 2 ml Expiry date - three months up to 5 human serum
Maternal Care each level 2 (only freeze hours /- matrix
04899881 bottles once)
PreciControl Y 2 levels, ≈ 30/100 2 ml Expiry date - one month 5 hours / 5 human serum
Anti-CCP$ each level U/ml (freeze only hours matrix
05031664 two bottles once)
PreciControl Y 2 levels, ≈ 0.5 / 10 4 ml Expiry date - three months -/ human serum
BRAHMS each level ng/ml (only freeze 2 hours matrix
PCT# two bottles once)
* Please check in package insert. # Calibrators and Controls are part of the test kit. $ controls not barcoded
Elecsys 2010 ®Controls
Control ready- Package Nominal Volume Stability Stabilit Stabilit Control material
Cat.no. to-use content range for per unopened y y on
cutoff index bottle 2-8 oC opened board
(qual.) 2-8 oC
Concentration
range (quant.)
PreciControl No 2 levels PC1: approx. 20 4.0 ml Expiry date 8 weeks 7 hours Anti-HAV antibodies (human)
Anti-HAV each level IU/l PC 1: ≈ 20 IU/l
11876350 two bottles PC2: approx. 35 PC 2: ≈ 36 IU/l
IU/l in human serum
PreciControl Y 2 levels PC1: negative 0.67 ml Expiry date 8 weeks up to 14 PC 1: human serum
Anti-HAV each level PC2: approx. 3 hours PC 2: Anti-HAV IgM antibodies
IgM eight bottles U/ml (human) ≈ 3 U/ml (PEI
11876368 units) in human serum
PreciControl Y 2 levels PC1: 1.05-3 1.3 ml Expiry date 8 weeks 5 hours PC 1: human serum
Anti-HBc each level PC2: 0.14-0.87 PC 2: Anti-HBc antibodies
11876325 eight bottles (human) ≈ 0.75 U/ml
(PEI units) in human
serum
PreciControl Y 2 levels PC1: 0-0.3 1.0 ml Expiry date 8 weeks 6 hours PC 1: human serum
Anti-HBc IgM each level PC2: 1.1-2.5 PC 2: Anti-HBc IgM antibodies
11876333 eight bottles (human) > 130 U/ml (PEI
units) in human serum
PreciControl Y 2 levels PC1: 1.2-2.1 1.3 ml Expiry date 8 weeks 6 hours PC 1: human serum
Anti-HBe each level PC2: 0.30-0.90 PC 2: Anti-HBe antibodies
11876384 eight bottles (human) ≈ 0.25 U/ml
(PEI units) in human
serum

Control ready- Package Nominal Volume Stability Stability Stability Control material
Cat.no. to-use content range for per unopened opened on board
cutoff index bottle 2-8 oC 2-8 oC
(qual.)
Concentration
range (quant.)
PreciControl Y 2 levels PC1: 0.0-0.5 1.3 ml Expiry date 8 weeks 6 hours PC 1: human serum
HBeAg each level PC2: 6.0-20.0 PC 2: HBeAg (E.coli, rDNA approx.
11876376 eight bottles 2.5 U/ml (PEI-units) in HEPES
PreciControl Y 2 levels PC1: < 5 IU/l 1.3 ml Expiry date 8 weeks 5 hours PC 1: human serum
Anti-HBs each level PC2: 60-150 IU/l PC 2: Anti-HBs antibodies (human)
11876317 eight bottles ≈ 100 IU/l in human serum
PreciControl Y 2 levels PC1: 0.0-0.80 1.3 ml Expiry date 8 weeks 5 hours PC 2: HBsAg (human) ≈ 0.2 IU/ml in
HBsAg II each level PC2: 2.6-5.0 human serum
04687876 eight bottles
PreciControl Y 2 levels PC1: 0-0.3 1.3 ml Expiry date 8 weeks 5 hours PC 2: Anti-HCV in human serum
Anti-HCV each level PC2: ~ 8
* see package insert

Control ready- Package Nominal Volume Stability Stability Stability Control material
Cat.no. to-use content range for per unopened opened on board
cutoff index bottle 2-8 oC 2-8 oC
(qual.)
Concentration
range (quant.)
PreciControl Y 3 levels * 2 ml Expiry date 8 weeks up to 5 PC 1: human serum, negative for
HIV each level hours HIV
05162645 two bottles PC 2: human serum, positive for
anti-HIV antibodies
PC 3: cirate buffer, pH 4.0, approx.
400 pg/ml HIV p24-Ag
* see package insert

Control ready-to- Package Nominal range Volume Stability Stability Stabi- Control material
Cat.no. use content for cutoff index per bottle unopened opened lity on
(qual.) 2-8 oC 2-8 oC board
Concentration
range (quant.)
PreciControl Y 2 levels PC 1: ~ 1.5 U/ml 1 ml expiry date 8 weeks 5 hours PC 1: human serum negative
CMV IgG each level PC 2: ~ 25 U/ml PC 2: human serum positive
PreciControl Lyo 2 levels PC 1: ~ 4 U/ml; 1 ml expiry date 4 weeks 5 hours PC 1: human serum low avidity
CMV IgG each level avidity < 45% PC 2: human serum high avidity
Avidity three bottles PC 2: ~ 25 U/ml;
05942322 avidity ≥ 55%
PreciControl Y 2 levels PC 1: negative 1 ml expiry date 8 weeks 5 hours PC 1: human serum negative
CMV IgM each level PC 2: positive PC 2: human serum positive
04784626 four bottles
PreciControl Lyo 2 levels PC 1: negative 3 ml expiry date 14 days 5 hours PC 1: human serum negative
HSV each level PC 2: positive PC 2: human serum positive
05572207 two bottles
PreciControl Y 2 levels PC 1: ~ 4 IU/ml 1 ml expiry date 8 weeks 5 hours PC 1: human serum negative
Rubella IgG each level PC 2: ~ 75 IU/ml PC 2: human serum positive
PreciControl Y 2 levels PC 1: negative 1 ml expiry date 8 weeks 5 hours PC 1: human serum negative
Rubella IgM each level PC 2: ~550 U/ml PC 2: human serum positive
04618840 four bottles
PreciControl Y 2 levels PC 1: ~ 1 IU/ml 1 ml expiry date 8 weeks 5 hours PC 1: human serum negative
Toxo IgG each level PC 2: ~ 50 IU/ml PC 2: human serum positive
PreciControl Y 2 levels PC 1: negative 0.67 ml expiry date 8 weeks 5 hours PC 1: human serum negative
Toxo IgM each level PC 2: ~125 U/ml PC 2: human serum positive
Elecsys 2010 ® Diluents

Diluent Package Volume per Stability Stability opened Stability on Contents
Cat.no. content bottle unopened 2-8°C board
2-8°C
Diluent Universal 2 bottles 16 ml Expiry date - 3 months protein matrix,
11732277 preservative ≤ 0.1%
Diluent Universal 2 bottles 36 ml Expiry date - 3 months protein matrix,
03183971 connected preservative ≤ 0.1%
Diluent MultiAssay 2 bottles 16 ml Expiry date - 1 month buffered equine serum
03609987 matrix
preservative
Diluent NSE 4 bottles 3 ml Expiry date 4 weeks - fetale bovine serum,
03004864 preservative ≤ 0.1%
Diluent Hepatitis A 2 bottles 15 ml Expiry date 6 weeks - human serum
11361252
Diluent 2 bottles 22 ml Expiry date 4 weeks - human serum of male
Estradiol/Progesterone03 blood donors
028542
Elecsys 2010 ® System reagents

System Package Volume Stability Stability Stability Stability on Stability Contents
reagent content per unopened unopened opened board on board
Cat.no. bottle 15-25°C 2-8°C opened unopened
ProCell 6 bottles 380 ml Expiry date - - 3 days 4 weeks Phosphate buffer,
11662988 tripropylamine, detergent,
preservative
CleanCell 6 bottles 380 ml Expiry date - - 3 days 4 weeks KOH, detergent
11662970
SysWash 1 bottle 500 ml - Expiry date 3 month 2 weeks - Detergent, preservative
11930346
SysClean 5 bottles 100 ml - Expiry date - - - Sodium hydroxide 3 mol/l,
11298500 (store solution sodium hypochlorite
(SysClean Adapter protected from solution < 2% Cl act.
11933159) light)
Elecsys 2010 ® System Accessories
System Accessories Description Package content

Cat.no.
AssayTips Disposable tips for pipetting samples and 30 x 120 tips
11706799 reagent
Assay Cups Reaction tubes for performing Elecsys® 60 x 60 cups
11706802 Immunoassays
CleanLiner Resealable plastic waste bags for the 1 * 14 bags
11800507 Elecsys® 2010 container
CalSet Vials Empty snap-cap vials for reconstituted 2 x 56 bottles
11776586 calibrator for direct use on Elecsys®
1010/2010 Systems
Control Vials Empty snap-cap vials for reconstituted 2 x 56 bottles
03142949 controls for direct use on Elecsys®
1010/2010 Systems
3.3 Elecsys® Universal Diluent or MultiAssay (MA) Recommendations
Reagent type Test Recommended dilution Concentration of

factor diluted sample
must be
Thyroid Function FT3 ∅
Test FT4 ∅
T3 ∅
T4 ∅
TSH 1:10 with Diluent MA > 10 µIU/ml
T-uptake ∅
TG 1:5 > 50 ng/ml
Anti-TG @
Anti-TPO @ 1:5 with Diluent Universal > 100 IU/ml
manually
Anti-TSHR 1:5 or 1:10 with Anti-TSHR > 4 IU/l
negative human sera*
Cardiac CK-MB (STAT ♥) 1:2 with Dil MA > 50 ng/ml
Digoxin 1:2 > 2.5 ng/ml
>3.2 nmol/l
Digitoxin 1:2 > 30 ng/ml
> 39 nmol/l
Myoglobin 1:10 > 50 ng/ml
(STAT)
proBNP II (STAT 1:2* > 15000 pg/ml
only on cobas e > 1770 pmol/l
601/2)
Troponin I 1:10 with Diluent MA > 3 ng/ml
(STAT)
Troponin T hs 1:10 with Diluent MA > 1000 ng/l
(STAT)
Hormones ACTH ∅
Cortisol 1:10 > 50 nmol/l
* (for urine samples) > 1.8 µg/dl
DHEA-S 1:5 with low concentrated human > 1.5 µmol/l
sera* > 45 µg/dl
Estradiol II 1:5 with Diluent MA > 1835 pmol/l
> 500 pg/ml
FSH ∅
HCG STAT 1:100 > 100 mIU/ml
HCG+β 1:100 > 100 mIU/ml
LH ∅
Progesterone II 1:10 with Diluent > 6 nmol/l
Estradiol/Progesterone ∇ * > 2 ng/ml
Prolactin II 1:10 > 50 µIU/ml,
> 2.4 ng/ml
SHBG 1:10 with Diluent MA > 20 nmol/l
Testosterone II ∅
Autodilution possible for bold mentioned dilution ratios

∅ Dilution not necessary due to the broad measuring range or can not be diluted because of changing
in the concentration of the binding proteins alters this equilibrium.
@ The autoantibodies are heterogeneous and this gives rise to non-linear dilution phenomena.
* Please check the package insert. ∇ Autodilution not possible.
Reagent type Test Recommended Concentration of

dilution factor diluted sample must be
Diabetes C-Peptide 1:10 with Diluent MA > 4 ng/ml
(serum and urine) > 1.3 nmol/l
Insulin ∅
Preeclampsia PlGF ∅
sFLT-1 ∅*
Tumor Marker AFP 1:50 > 20 U/ml,
> 24 ng/ml
CA 125 II 1:5 > 1000 U/ml
CA 15-3 II ∞ 1:10 ♣ > 30 U/ml
CA 19-9 1:10 > 50 U/ml
CA 72-4 1:2 > 150 U/ml
CEA 1:50 > 20 ng/ml
Cyfra 21-1 1:2 > 250 ng/ml
NSE 1:2 with Diluent NSE ∇ > 50 ng/ml
Free PSA ∅
total PSA 1:50 > 2 ng/ml
S100 1:5 with S100 negative > 1 µg/l
human serum or CalSet
1
Down`s Free ßhCG 1:10 with Diluent > 19 IU/l
syndrome Universal
screening PAPP-A 1:10 with Diluent > 500 mIU/l
Universal
Anaemia B12 1:2♣ > 1000 pg/ml,
>738 pmol/l
Ferritin 1:50 > 40 ng/ml
Folate III 1:2♣ > 10 ng/ml,
> 22.7 nmol/l
RBC Folate 1:2 with 0.2% ascorbic >16.2 nmol/l
acid solution > 8 ng/ml
Bone ß-CrossLaps ∅
Osteocalcin 1:5 > 60 ng/ml
PTH (STAT) ∅
PTH (1-84) 1:2 with Diluent > 1150 pg/nl
Universal > 122 pmol/l
total P1NP 1:2 > 100 µg/l
Vitamin D total 1:2 with Diluent > 35 ng/ml
Universal > 87.5 nmol/l
∅ Dilution not necessary due to the broad measuring range or not possible e.g. can not be diluted
because of changing in the concentration of the binding proteins alters this equilibrium.
# Diluent Universal can be used to dilute the samples. * Please check the package insert
♣ Autodilution not possible due to this assays are three step methods. - no information
∞ Use Elecsys® Diluent Universal for automatic sample predilution.
∇ Autodilution not possible.
STAT Tests possible on cobas e 601 (SW 04-03 onwards).
Reagent type Test Recommended dilution Concentration of

factor diluted sample
must be
Varia IgE II 1:20 > 125 IU/ml,
> 300 ng/ml
Rheumatoid Anti-CCP 1:2 to 1:5 with neg. human
Arthritis sera*
Sepsis Brahms PCT 1:4 with neg. human sera > 1.0 ng/ml
IL 6 1:10 with Diluent MA > 50 pg/ml
Infectious Anti-HAV with Diluent Hepatitis A ∇ > 20 IU/l
Diseases
Anti-HAV IgM ∞ #
Anti-HBc #*
Anti-HBc IgM ∞ #
Anti-HBe #*
HBeAg #*
Anti-HBs 1:100 with Diluent > 10 IU/ml
Universal
HBsAg / HBsAg *
II
HBsAg II quant 1:100 with Diluent HepB*
HIV Ag *
HIV combi
HIV combi PT *
Torch CMV IgG 1:20 with Diluent ≥ 15 U/ml
Universal
CMV IgG Avidity 1:20 with Diluent Universal*
CMV IgM∞ *
HSV-1 IgG *
HSV-2 IgG *
Rubella IgG 1:20 with Diluent > 10 IU/l
Universal
Rubella IgM∞ #*
Toxo IgG 1:20 with Diluent > 3 IU/l
Universal
Toxo IgM∞ #*
∅ Dilution not necessary due to the broad measuring range, or cannot be diluted as this changes the
concentration of the binding proteins and therefore alters the equilibrium.
# Diluent Universal can be used to dilute the samples.
♣ Auto-dilution is not possible as assay uses a three-step method.
∞ Use Elecsys® Diluent Universal for automatic sample predilution.
∇ Autodilution not possible.
* Please check package insert.
Used Documents:
Assay Package Application report
insert
FT3 1109/12 2ft2050b.xls (NCCLS precision)
FT4 0810/17 2ft4050a.xls (NCCLS precision)
T3 0409/18 2_t3050a.xls (NCCLS precision)
T4 0510/15 2_t4050a.xls (NCCLS precision)
TSH 0510/19 2tsh050a.xls (NCCLS precision)
T-uptake 0409/16 2tbk050a.xls (NCCLS precision)
TG 0310/05 2tg_050a.xls (NCCLS precision)
TG Confirmatory Test 0710/03
Anti-TG 0710/02 2atg050a.xls (NCCLS precision)
Anti-TPO 1010/03 2tpo050c.xls (NCCLS precision)
Anti-TSHR 0610/08 2ATR050a.xls (NCCLS precision)
CK-MB 0511/01 2_3AR01_Applicaiton Report Summary_CK-MB.doc
Myoglobin STAT 0810/16 2myo050a.xls (NCCLS precision)
proBNP II 0510/05 2bn2050a.xls (NCCLS precision)
Troponin T STAT hs 0110/03 2TS9050a.xls (CLSI precision)
Troponin I STAT 0310/02 2_050a_EP5Precision_TNIstat.xls (CLSI precision)
Digoxin 0610/15 2dig050a.xls (NCCLS precision)
Digitoxin 0310/09 2dit050a.xls (NCCLS precision)
HCG STAT 1109/13 2HC2050c.xls (NCCLS precision)
HCG+β 0310/14 2hb2050a.xls (NCCLS precision)
ACTH 0810/05 2acth050a.xls (NCCLS precision)
Cortisol 0710/17 2cor050a.xls (NCCLS precision)
DHEA-S 0509/14 2dhe050a.xls (NCCLS precision)
Estradiol II 0509/15 2e22050a.xls (NCCLS precision)
FSH 0509/16 2fsh050b.xls (NCCLS precision)
LH 0509/16 2_lh050a.xls (NCCLS precision)
Progesterone II 0810/13 2pg2050b.xls (NCCLS precision)
Prolactin II 0509/03 2pro050a.xls (NCCLS precision)
SHBG 0509/08 2shg050a.xls (NCCLS precision)
Testosterone II 0710/04 2_050a_EP5Precision_TestoII.xls (CLSI precision)
C-Peptide 0810/05 2cpe050a.xls (NCCLS precision)
Insulin 0810/10 2in1050a.xls (NCCLS precision)
PlGF 0810/03 2PLGF050a.xls (CLSI precision)
sFlt-1 0710/03 2SFL050b.xls (CLSI precision)
AFP 0410/09 2af2050a.xls (NCCLS precision)
CA 125 II 1110/12 2125050a.xls (NCCLS precision)
CA 15-3 II 0210/13 2215050a.xls (NCCLS precision)
CA 19-9 0410/18 2192050a.xla (NCCLS precision)
CA 72-4 0410/08 2724050a.xls (NCCLS precision)
CEA 0410/18 2ce2050c.xls (NCCLS precision)
Cyfra 21-1 0310/14 2cyf050a.xls (NCCLS precision)
NSE 0310/03 2nse050b.xls (NCCLS precision)
free PSA 0610/09 2pf050b.xls (NCCLS precision)
total PSA 0510/07 2ps2050c.xls (NCCLS precision)
S100 0510/07 2sc_050a.xls (NCCLS precision)
Free ßhCG 0610/04 2PAP050a.xls (NCCLS precision)
PAPP-A 0907/01 2fHC050a.xls (NCCLS precision)
Assay Package Application report

insert
Vitamin B12 0710/06 2b22050a.xs (NCCLS precision)
Ferritin 0510/10 2ffg050b.xls (NCCLS precision)
Folate III 0810/06 2Fo3050a.xls (NCCLS precision)
RBC Folate 0810/14 na
β-CrossLaps/serum 0310/10 2ßCL050b.xls (NCCLS precision)
N-MID Osteocalcin 0308/11 2oc050c.xls (NCCLS precision)
PTH STAT 0710/07 2PTH050a.xls (NCCLS precision)
PTH (1-84) 0511/01 2_3_ARb_SummaryReport_PTH 1-84.doc
total P1NP 0508/06 2P1_050a.xls (NCCLS precision)
Vitamin D total 0810/10 2vid050a.xls (NCCLS precision)
IgE II 0509/04 2ig2050b.xls (NCCLS precision)
Anti-CCP 0210/03 2acc050c.xls (NCCLS precision)
BRAHMS PCT 0210/04 2PCT050c.xls (NCCLS precision)
IL-6 0710/03 2_050b_EP5_IL-6.xls (CLSI precision)
Anti-HAV 0210/07 Precision from PEI report
Anti-HAV IgM 0410/11 Precision from PEI report
Anti-HBc 0610/20 Precision from PEI report
Anti-HBc IgM 0720/13 Precision from PEI report
Anti-HBe 0610/13 Precision from PEI report
HBeAg 0610/15 Precision from PEI report
Anti-HBs 0610/16 Precision from PEI report
HBsAg II 0710/05 Precision from PEI report
HBsAg II quant 0111/02 HBsAgII-quant-application-report-
summary.doc
HBsAg Confirmatory 0610/21 na
Test
Anti-HCV 0610/07 Precision from internal evaluation report
HIV Ag 0610/10 Precision from internal evaluation report
HIV Ag Confirmatory 1108/09 na
Test
HIV combi 0609/04 Precision from internal evaluation report
HIV combi PT 0910/01 Precision from internal evaluation report
CMV IgG 0210/03 2CMG050a.xls (NCCLS precision)
CMV IgG Avidity 0910/01 2_3_ARf_SummaryReport_CMV IgG
Avidity.doc
CMV IgM 0609/02 2CMM050a.xls (NCCLS precision)
HSV-1 IgG 1110/01 2_050a_EP5Precision_HSV1IgG.xls
HSV-2 IgG 1110/01 2_050a_EP5Precision_HSV2IgG.xls
Rubella IgG 0310/05 Precision from internal evaluation report
Rubella IgM 0310/05 Precision from internal evaluation report
Toxo IgG 0210/08 Precision from internal evaluation report
Toxo IgM 0410/06 Precision from internal evaluation report
na not available
Used Documents:
CalSet Package insert

FT3 0610/07
FT4 0610/11
T3 0907/10
T4 0707/10
TG 0308/08
TSH 0810/05
T-uptake 0907/12
CK-MB STAT 0511/01
Myoglobin STAT 1209/12
proBNP II 1007/02
Troponin T STAT hs 0610/03
Digoxin 0410/09
Digitoxin 0310/09
HCG STAT 0809/07
HCG+β 0610/08
ACTH 0310/03
Cortisol 0410/09
DHEA-S 0310/08
Estradiol II 0310/08
FSH II 0310/08
LH II 0310/08
Progesterone II 0310/12
Prolactin II 0310/03
SHBG 0310/05
Testosterone II 0310/02
C-Peptide 0310/04
Insulin 0907/07
PlGF 1008/01
sFlt-1 1008/01
Used Documents:
CalSet Package insert

AFP II 0610/05
CA 125 II 0610/08
CA 15-3 II 0610/08
CA 19-9 0707/13
CA 72-4 0310/09
CEA 0707/11
Cyfra 21-1 0807/07
NSE 0310/06
free PSA 0510/08
total PSA II 0610/06
S100 0907/05
Free ßHCG 0210/03
PAPP-A 0907/01
Vitamin B12 II 0707/03
Ferritin 0610/06
Folate III 0708/01
β-CrossLaps/serum 0707/07
N-MID Osteocalcin 0610/10
PTH STAT 0809/03
PTH (1-84) 0511/01
total P1NP 0907/04
Vitamin D total 0211/01
IgE 1207/10
IL-6 1108/01
Used Documents:
Controls Package insert

PreciControl Universal 1010/05
PreciControl Cardiac II 0510/05
PreciControl Troponin 0110/02
PreciControl TSH 0607/10
PreciControl Tumormarker 0510/15
PreciControl Varia 0311/01
PreciControl ThyroAB 1209/02
PreciControl Maternal Care 0510/02
PreciControl Multimarker 0810/01
PreciControl Anti-CCP 1008/02
PreciControl Anti-HAV 0410/05
PreciControl Anti-HAV IgM 0810/12
PreciControl Anti-HBc 0610/15
PreciControl Anti-HBc IgM 0807/09
PreciControl Anti-HBe 0610/11
PreciControl HBeAg 0907/08
PreciControl Anti-HBs 0610/14
PreciControl HBsAg II 0610/05
PreciControl Anti-HCV 0610/04
PreciControl HIV 0810/02
PreciControl CMV IgG 1108/01
PreciControl CMV IgG Avidity 1010/01
PreciControl CMV IgM 0908/01
PreciControl HSV 1110/01
PreciControl Rubella IgG 0707/02
PreciControl Rubella IgM 0310/04
PreciControl Toxo IgG 0807/03
PreciControl Toxo IgM 0710/05
”System” Reagents Package insert

Diluent Universal 2*16 ml 0410/15
Diluent Universal 2*36 ml 0310/07
Diluent MultiAssay 2*16 ml 0310/06
Diluent NSE 0310/07
Diluent Estradiol/Progesterone 0410/07
Diluent Hepatitis A 0907/06
ProCell 0410/13
CleanCell 0410/17
SysWash Productinfo 12/09
SysClean/SysClean adapter 0608/05
For this document are the contents of the current Elecsys® reagent kit, CalSet,
PreciControl and System reagent package inserts and Application Reports used. The
used package insert versions and Application Reports are listed above.Original datas
are available in the corresponding package inserts and Application Reports.
3.4 Checklist of reagent handling
This is a list of questions you should ask operators with unresolved problems.
Reagent Handling
• Did you adjust temperature of the reagent kit before starting the instrument?
• Were the reagent kits within the allowed stability after opening or were the expiry
dates exceeded?
• Did you observe any foam?
• Did you store the reagent kit in an upright position and at the right temperature (2-
8°C*)?
* The temperature of the fridge should be ≥ 2°C because the microbeads must not
freeze.
Calibrator Handling
• Did you bring the calibrators to room temperature before starting the instrument?
• Were the lyophilized calibrators carefully dissolved? Did you bring the
reconstituted calibrators to room temperature and allow to stand closed for 15
minutes after 1 ml distilled water was added?
• Did you carefully mix the calibrators avoiding the formation of foam?
• Did you transfer the calibrators into the correct bar-coded vial?
• Did you close the calibrator bottles (no single use calibrators) after calibration as
soon as possible? Because of possible evaporation effects, the on board stability
of the calibrators must not be exceeded.
• Did you aliquot and freeze the calibrators? This is recommended for some
CalSets, e.g. CK-MB, Troponin T.
• Did you check that the calibrators were within the allowed stability after opening?
Control Handling
• Did you carefully reconstitute the lyophilized controls (see calibrators) e.g. with 3
ml for PreciControl Universal (stand closed for 30 minutes) according to the
information in the package insert?
• Did you transfer the controls into the correct bar-coded vial?
• Did you check that the controls were within the allowed stability after opening and
that the expiry date was not exceeded?
• Did you observe foam on the controls?
• Did you aliquot and freeze controls? This is recommended e.g. for PreciControl
Universal.
Sample Handling
• Did you use the recommended sample containers (outside diameter < 13 mm)?
• Did you use the recommended cup adapter for Elecsys® 2010 rack system when
13 mm sample tubes are used?
• Did you notice air bubbles or foam on the surface of the sample?
• Did you check that the sample stability were not exceeded? Check the package
insert.
• Was dead volume within the specified range? Please check attached list of dead
volume.
• Did you prepare the sample material carefully? Did you allow 30 minutes waiting
time for clotting? Did you centrifuge the samples before putting them on the
analyzer?
• Did the sample contain precipitates? Sample containing precipitates must be
centrifuged before testing at a minimum of * 2500 rpm for 10 min (primary and
normal cups).
• Did you check if there was enough sample volume (plasma)?
• Did sample cups fit correctly in sample disk or rack?
System Reagent Handling
• Did you store the system reagents at room temperature?

• Did you allow the system reagents to reach the correct temperature on board (15
minutes from room temperature/ 1 hour from 4 °C) before starting the instrument?
• Did you check that the system reagents were within the allowed stability after
opening and that the expiry date was not exceeded?
• Did you close the system reagent bottles overnight?
• Did you mix the contents of different bottles?
• Did you replace the empty bottles from left to right side on Elecsys® 2010?
• Did you observe any foam within system reagents?
System Water Handling
• Did you use distilled water according to specification (conductivity ≤ 10 μS)?

• Did you carefully refill containers with distilled water in order to avoid air bubbles?
Diluent
• Did you use the recommended dilution ratio?

• Is the end concentration after dilution still according to recommendations?
• Did you check that the Diluent was within the allowed stability after opening and
that the expiry date was not exceeded?
• Did you check the Diluent is recommended for this particular assay? Please check
the attached ”dilution list”.
Maintenance
• Did you regularly perform maintenance as described in the operation manual

(user’s guide)?
Lab
• Did you check, whether the temperature and humidity of the lab is within the
defined specification mentioned in the operator’s manual?
• Is the EMI compliance fulfilled (electromagnetic interferences)?
3.5 List of sample container dead volumes
Cup selection NORMAL Tube Software 06-x

height
Disk Rack
Primary tube (∅16 mm) 100 1000 1000
Primary tube (∅16 mm) 75 1000 1000
Primary tube (∅13 mm) 100 600 600
Primary tube (∅13 mm) 75 600 600
Sample cup on disk/rack 200 200
Sample cup on tube 100 200 150
Sample cup on tube 75 200 200
Control/Calibrator vial 150 150
Cup selection Reduced
Sample cup on disk/rack 100 100
Sample cup on tube (∅16 mm) 100 150 100
Sample cup on tube (∅ 16 mm) 75 150 100
A reduced dead volume may only be used with Hitachi standard cups (not with primary or secondary cups).
Cup adapter is recommend when primary tubes with 13 mm are used on sample racks.
∅ represents the outside diameter of the sample tube.
August 2011
Troubleshooting Elecsys® Systems
3.6 Sensitivity of assays to systems malfunctions and system phenomena
Note: The list in Section 3.6 is based on results and experience from internal studies and
from customer complaints. Please note that this compilation cannot be complete,
since in most cases complaints and troubleshooting actions are not based on an
assessment with all assays.
System Components Key Parameters Effects Trouble Shooting

Influence on Hints
Pipetting unit
- deadjustment of pipettor <HBc>, <HBc>IgM, Imprecision, false Adjustment of pipettor
- pipettor leaky Digoxin results (SB E2010/149,
(assays with small e411/84)
sample volumes or Change nozzle seal
reagent with high
density)
- mispipetting due to contact HBsAg False negative results Use specified sample
of pip. probe with sample cups
cup (air or air and sample Check correct
pipetted) positioning of cups
- no / too less calibrator / fT4 Extremely high signals Ensure that no
sample volume pipetted bubbles are on the
sample surface / no
droplets are on inner
sample cup wall
causing premature
LLD.
- no conjugate (R2) pipetted TSH Values < LDL
or foam on R2 (sandwich assays)
Mixing unit
- paddle geometry incorrect T3, FT3, CEA, False results, outliers Check paddle shape
T-uptake  (SN 32/98)
- mixer speed not within FT3, E2, AFP False results, outliers Check mixer speed
specifications  (SN 32/98)
Transport system
- gripper dirt falls into vessels HCG False results, outliers  Clean gripper finger
Measuring unit
- magnet disalignment Anti-HBc, CEA Diff. in signal levels Check magnet
Imprecision adjustment
- Tighten torque / alignment TNT STAT False positive results Loosen connection
problem of tubings attached between Möller
to measuring cell tubings & mc. Re-
align tubings & mx
inlet using nylon cord,
SB 2/2000.
- MC/Ref. Electrode Anti-HB>, Diff. in signal levels LFC (SN 22/98)
(RE lifted, deposits, ?) Testosterone, FSH, Imprecision, drifts Change MC or RE
E2 (SN 08/98; 21/98)
Fluidic system
- tubings (leaky, dirty) FT3, T3, FT4, T4 False results Change tubings and
(preheat pipe  MC check

Influence on Hints
sipper  preheater) Imprecision, drifts junctions/fittings
- sample pipettor probe Digoxin Imprecision Adjust sample pipettor
deadjusted probe. Adjustment
has an influence on
the mixing of incubate
(R1/SA). (SB
2010/149, cobas e
411/84).
- sipper nozzle sealing TSH, CEA, <HBs> Imprecision within runs Change nozzle seal
deformed
- junction between sipper TSH, CEA Imprecision within runs Check fittings
tubing and sipper nozzle
seal vary
- sipper probe clotted FT3, FT4, TSH False results, drifts, Rinse sipper probe
imprecision with water
Change sipper probe
- sipper probe deadjusted Anti-HBc Imprecision, duplicate Adjust sipper probe
limit errors
- pinch tubes damaged Several tests Impecision, duplicate Change pinch tubes
limit errors every two months (SB
43/2003)
- system volume incorrect T3, T4 False results, Check system volume
imprecision
- filter MD6 clotted/rinsing <HBc>, <HBc>IgM, Carry Over Cleaning or change of
process of rinse station AFP Imprecision rinse station
varies
- bubbles in system water FT3 False results, outliers 
- clogged heat pipe Testosterone Concentration Carry out LFC or if
Recovery decrease  this does not help,
exhange heat pipe

Influence on Hints
Temperature unit
- reagent rotor temp. <HBc> Signals , imprecision Check temperature
incorrect
System reagents (PC/CC)
- bottle change over ProCell CEA, TnT Signal jumps Reason unknown ,
Altered signal levels Instr.-dependent
flagged in SW-
versions > 3.08
LFC
- not carried out regularly E2, Progesterone Increasing Imprecision Carry out LFC
FSH, LH, B12, Signals 
Folate, Anti-HBc
Using of HRT (Hormone Replacement Therapy) hand cream
E2 PC U out of range Use gloves
Preparation of Progesterone capsules in the IVF lab
Progesterone Increasing Preparation of
Progesterone Progesterone
concentrations in single capsules in another
samples lab
3.7 Foam on calibrators / samples / reagents
FALSE RESULTS/ZERO VALUES ON MODULAR ANALYTICS <E>
Foam on calibrators, samples, controls and reagents

Sandwich assay format Competitive assay format
(TSH, HCG, CEA) (T3, FT3, T4)
Effect on values Effect on values Comments
(conc.) (conc.)
Control/Sample ()  Except TSH +
HBsAg () due
to matrix effects
for samples in
very low
concentrations
(close to 0)..
R1  
R2  
Microbeads  
Calibrators Effect on values Effect on values
(signal) (signal)
Cal 1 ()  Except TSH +
HBsAg ()
(sample volume
50 µl) due to
matrix effects
Cal 2  
Dr. A. Sauer, System Qualification June 97
4. ELECSYS® 2010: OVERVIEW LOT AND RACKPACK CALIBRATION
RackPack
< 24 hrs > 24 hrs

on board on board
all cal criteria o.k. one cal criteria not o.k. auto system release
auto system release release by operator
Lot Calibration RP Calibration RP Calibration

(operator released) (system released)
valid for all RPs of valid only CALIBRATION valid only

the same lot for this RP for this RP
controls and samples controls and samples controls and samples

prior to operator release will following operator release CONTROLS following system release will
use previous lot cal will use this RP cal and SAMPLES use this RP cal
Operator released RP calibration only on Elecsys® 2010 and not available on cobas e 411.
Thomas Hartke, Global Product Management, Claudia Schäfer, Global Systems Support December 06
5. ELECSYS® 2010 ASSAY CALIBRATION
5.1 Lot calibration, reagent pack calibration
Lot calibration: A lot calibration is a calibration performed with a fresh

reagent pack that has not been on board the analyzer longer
than 24 hours and all calibration validation criteria are ok.
The lot calibration is valid for all other reagent packs of the
same lot.
RackPack calibration: A RackPack calibration will be performed with a reagent that

has been on board the analyzer more than 24 hours or is
generated by an operator-released calibration (Elecsys®
2010 only). If one validation criteria is not ok (exception
monotony/slope) the customer can release the calibration. A
RackPack calibration is valid for one specific RackPack pack
only.
Calibration System-released calibration Operator-released calibration

due to reagent > 24hours on due to one calibration
board validation criteria not ok
Controls System-released calibration previous calibration will be

will be used. used until above mentioned
calibration will be released by
the operator
Samples System-released calibration previous calibration will be

will be used. used until above mentioned
calibration will be released by
the operator
5.2 Calibration validation criteria
Quantitative Assays Qualitative Assays
• Deviation of duplicate limit • Deviation of duplicate limit

• Minimum signal • Minimum signal
• Missing values • Missing values
• Monotony (Slope) • Slope (Monotony)
• Calibration factor • Maximum signal
• Minimum acceptable difference* • Minimum acceptable difference
* available in software 06-x
mean high signal – mean low signal)
* Calculation minimum acceptable difference: ------------------------------------------------- > = 0.3
mean low signal
5.3 Calibration stability (please check the package insert)
Obligation • calibration each new reagent lot
Recommendation • as required: e.g. quality control finding outside the specified

range
• calibration every four weeks (when using the same reagent
lot)
• calibration every seven days (when using the same reagent
kit on the analyzer) (there are some exceptions e.g. Anti-TPO,
please check the package insert)
Reagent stability (please check the package insert)
Calibrator stability (please check the package insert)
5.4 Calibrator Concept
• single calibrator
• multi use
• Calibrators are measured in duplicate
• CBR Concept for non-infectious diseases
• primary vial concept (plastic vial, snap cap)
5.5 Calibration procedure when > one Reagent pack for one assay on board
Software V 03-08/12 Software V 06-x

Example Software V01-39 and V02-13/14
(final software)
2 Reagent packs (RPs) (same lot): Automatic calibration request of the Automatic calibration request of the Each RP can be
1 Reagent pack (old, previous used new RP. Control and samples are new RP. Control and samples are requested which should
RP) pipetted with the old RP. pipetted with the old RP, when the be calibrated and or
1 Reagent pack (new) control vial(s) is not positioned directly controlled.
behind CalSet vials.
If there is no calibration
In the case that the control vial(s) is request by the customer
directly positioned behind the CalSet, there will be an
the control(s) is pipetted with the new automatic calibration
RP and the samples are pipetted with request by the software,
the old RP. similar to software
In the case of a manual calibration version 03-x with
request of the old RP (switch off the exception of control of
calibration request of the new RP), calibration. This feature
control and samples are pipetted with is not available any
the old RP. more.
In the case of an additionally manual
calibration request of the old RP and
the control vial(s) is directly positioned
behind the CalSet, the control(s) is
pipetted with the old and the new RP
and the samples are pipetted with the
old RP.

(final software)
3 Reagent packs (RPs)(same lot): Automatic calibration request of the Automatic calibration request of the Each RP can be
1 Reagent pack (old, previous used new RP with the lower position new RP with the lower position requested which should
RP) number. Controls and samples are number. Controls and samples are be calibrated and or
1 Reagent pack (new) pipetted with the old RP. pipetted with the old RP, when no controlled.
1 Reagent pack (new) additional manual calibration request
and when the control vial(s) is not
request by the customer
positioned directly behind CalSet vials
there will be an
(please check first case).
automatic calibration
request by the software,
similar to software
version 03-x with
exception of control of
calibration. This feature
is not available any
more.
2 Reagent packs (RPs)(same lot): Automatic calibration request of the Automatic calibration request of the RP
1 Reagent pack (new) RP with the lower position number. with the lower position number.
1 Reagent pack (new) Control(s) and samples are also Control(s) and samples are also
pipetted with this RP. pipetted with this RP, when no
additional manual calibration request
of the second RP.
2 Reagent packs (RPs)(different lot): Automatic calibration request of Automatic calibration request of the RP
1 Reagent pack (old, previous used both Rps. Control(s) and samples with the new lot. A manual request of
RP) are pipetted with the old RP. the RP with the old lot is possible.
1 Reagent pack (new) Depending on the control position(s)
and the calibration request is the
control(s) pipetted with the new and/or
old lot (please check first case).
Samples are pipetted with the old lot.

(final software)
2 Reagent packs (RPs)(different lot): Automatic calibration request of Automatic calibration request of the RP Each RP can be
1 Reagent pack (new, previous used both RPs. Control and samples are with the new lot. A manual request of requested which should
Lot) piptetted with the RP of the lower the RP with the old lot is possible. be calibrated and or
1 Reagent pack (new) position number. Depending on the control position(s) controlled.
and the calibration request is the
control(s) pipetted with the new and/or
request by the customer
old lot (please check first case).
there will be an
Samples are pipetted with the new
automatic calibration
lotbecause this is the current RP.
request by the software,
similar to software
version 03-x with
exception of control of
calibration. This feature
is not available any
more.
2 Reagent packs (RPs)(same lot): Take off the old RP. After finishing Automatic calibration request of the
1 Reagent pack (old, previous used the calibration incl. measurement of new RP. Control(s) and samples are
RP) control(s) take off all RP of the test pipetted with the old RP, when the
1 Reagent pack (new), but new and perform a reagent scan. If this control vial(s) is not positioned directly
Reagent pack should be controlled scan has finished replace both RPs behind CalSet vials.
after calibration but sample should and perform an additional reagent In the case that the control vial is
measured with the old Reagent pack scan. If the additional scan is not directly positioned behind the CalSet
performed the new Reagent pack the control is pipetted with the new RP
will be used for pipetting because it and the samples are pipetted with the
is the current Reagent pack (used old RP.
for calibration).
QC mode
Example E2010 Software 06-x , cobas e 411 Software 01-x/02-x

4 reagent packs (RPs) (same lot): Controls are measured daily for each reagent pack.
1 reagent pack (current, previously used RP, < 24 Recommendation 1 (time!):
hours on board) The control should be measured first with current reagent pack.
3 reagent packs (SB1, 2, 3, < 24 hours on board) A) Control is within the defined range. Control request for all other SBs recommended.
B) Control is out of the defined range for the current reagent pack.
Request a manual calibration for the current reagent pack incl. control of calibration.
Check the registration time to check, whether In case calibration was successul, control request for all other SBs recommended. Lot calibration
reagent pack is < or > 24 hours on board. transfer to SB1, SB2, SB3.
Recommendation 2 (money!):
The control should be measured with all reagent packs.
For reagent packs, which are not within the defined control range, all affected reagent packs have to
be calibrated and controlled.
Samples will be pipetted with the current reagent pack.
1 reagent pack (current, previously used RP, > 24 If a control is measured out of range for one of the new reagent packs (e.g. SB1), this RP has to be
hours on board) calibrated and controlled. In case all calibration criteria are within the limits a RP calibration is generated
2 reagent packs (SB1, 2, > 24 hours on board) because the reagent pack is on board > 24 h.
1 reagent pack (current, previously used RP, > 24 If a control is measured out of range for one of the new reagent packs (e.g. SB1), this RP has to be
hours on board) calibrated and controlled. In case all calibration criteria are within the limits a new lot calibration is
2 reagent packs (SB1, SB2, < 24 hours on board) generated because the reagent pack is on board < 24 h.
SB2 will keep the old calibration parameter.
For further not yet used stand by reagent packs e.g. SB3, SB4, the latest carried out lot calibration of
SB1 is used.
SB = stand by reagent pack
Please note, that it is not possible to transfer a newly generated lot calibration to a reagent pack which was already used.
To avoid two recommendations “money” and “time” for each example, only the “money” recommendation was described in most of the cases.
Time out triggered calibration not available on Elecsys 2010 and cobas e 411!
Within the inventory there is the information when the lot calibration and reagent pack calibration has to be carried out. But if the calibration is not
carried out, there is no hint.
Workaround for Anti-TSH Receptor and Anti-TPO (each reagent pack has to be calibrated and in addition each day)
 usage of daily calibration feature  calibration request for each reagent kit and every day (lot calibration not possible, calibration is
deleted every night)
Usage of daily calibration feature not possible for Anti-HCV (each reagent pack has to be calibrated and in addition each 7 days), because otherwise
each reagent pack would receive a calibration request, although the calibration is only necessary every 7 days.
QC violation available on cobas e 411
Example cobas e 411 software version 01-x/02-x

3 reagent packs (RPs) (same lot): Controls are measured daily for each reagent pack. If a control is measured out of range for
1 reagent pack (current RP, > 24 hours on SB1, the Software triggers a calibration request for SB1 (QC violation).
board) Recommendation to carry out a further control measurement. If control is within the limits, the
2 reagent packs (SB1, SB2, < 24 hours on recommendation for the calibration disappears.
board) If the control is still out of limits, SB1 is assigned for a lot calibration (if all calibration criteria are
within the limits) as SB1 is < 24 hours on board.
SB2 will keep the old lot calibration parameter (valid at the control pipetting time).
For further used not yet used stand by reagent packs e.g. SB3, SB4, the latest carried out lot
calibration of SB1 is used.
Samples will be pipetted with the current reagent pack.
2 reagent packs (RPs) (same lot): Both reagent packs are controlled and out of range. Software triggers a calibration for both
1 reagent pack (current RP, < 24 hours on reagent packs (QC violation). Both reagents have to be calibrated and controlled.
board) Recommendation to carry out a further control measurement. If control is within the limits, the
1 reagent packs (SB1, < 24 hours on board) recommendation for the calibration disappears.
If the control is still out of limits, SB1 is assigned for a lot calibration (if all calibration criteria are
within the limits) as SB1 is < 24 hours on board.
Calibration reference
Example Software 06-x (final Software)

2 reagent packs (RPs) (same lot): Calibration is requested for the first reagent pack and control of calibration. For the second
2 reagent packs (new, < 24 hours on board) reagent pack is a stand by QC requested.
After run start will be calibrated reagent pack 1 (lot calibration) and controlled and then the
second reagent pack controlled.
Please note that the calibration curve transfer is at the time were the first determination is
pipetted. Therefore the second reagent pack is not using the lot calibation of reagent pack 1,
because the calibation is not available at this time. The second reagent pack is using the latest
available lot calibation.
Therefore the recommendation is in this case to request the calibration for the first reagent
pack and control of calibration. When the calibration was successful and the control value
within the expected range, request the stand by QC for the second reagent pack.
5.6 Examples of control of calibration in Elecsys® 2010 software version 03-08/12 (not avail. in 06-x or cobas e 411)
a) TSH CalSets, T4 CalSets, PCU(s): Control of Calibration with chosen RP T4.
b) TSH CalSets, T4 CalSets, empty space, PCU(s): Control as specified in the control definition.
c) TSH CalSets, PCU(s), T4 CalSets, PCU(s): Control of Calibration for RP TSH and RP T4.
d) TSH CalSets, empty space, PCU(s), T4 CalSets, PCU(s): Controls after TSH CalSets as specified in the control definition and control of
calibration with chosen RP T4.
e) HCG CalSets (RP1), HCG CalSets (RP2), PCU(s): Control of calibration with both RPs HCG.
Note: The Control of calibration feature is not any more available in software version 06-x, as each reagent kit can be selected to be
controlled. Please note that in case that a reagent pack has been selected in the Inventory screen to be controlled this has
priorisation. The additional assays selected for e.g. PCU in the control definition will then be ignored.
If no reagent kit will be in the Inventory screen selected to be controlled the assays (current reagent kits) will be controlled as defined
in the control definition screen.
5.7 Main differences concerning assay calibration between different Elecsys® 2010 software versions
Differences concerning Software V01-39/V 02-13/14 Software V03-08/12 and 06-0x (final software)
Expired Reagent packs Can not be used for calibration. Can be used for calibration, but it will be then
”only” a reagent pack calibration.
Calibration factor The first Lot calibration utilizes a calibration factor Each Lot calibration utilizes a calibration factor 1.
1. The following calibrations (independend of Lot The following Reagent pack calibrations are
or Reagent pack calibration) are compared with compared with the last measured Lot calibration.
this first Lot calibration.
Software 03-x
Software 01-39
Calibration successful 0.6 - 1.4
Calibration questionable 0.4 - 0.59 or 1.41 - 1.6
Calibration failed < 0.4 or > 1.6
Software 06-x (final software)
Advantage: Five instead of four calibration
validation criteria for each calibration. Calibration successful 0.8 - 1.2
Disadvantage: Is the first Lot calibration e.g. Calibration questionable 0.6 - 0.79 or 1.21 - 1.4
because of a ”not recommended reagent handling” Calibration failed < 0.6 or > 1.4
not ok the subsequent calibrations can sometimes
not be released. This is the reason why the limits Advantage: No change in workdisks is necessary
of the factor are widen in software 02-x. Change of when the first Lot calibration e.g. because of a ”not
the workdisk is necessary. recommended reagent handling” is not ok.
Software 02-x Disadvantage: Only four calibration validiation
criterea when a Lot calibration is carried out.
Main differences concerning assay calibration between different software versions
Differences concerning Software V01-39 and V02-13/14 Software V03-08/12, 06-x (final software)
Calibration validation criteria Value below minimum signal will be used for Value below minimum signal or above maximum
calibration calculation signal will not be used for calibration calculation.
Differences concerning Software V01-39 and V02-13/14 and V03- 06-x (final software version)
08/12
Calibration validation criteria Monotony is ok, when there is only 1 count Monotony is ok, when there is only 1 count difference
difference between CalSet 1 and CalSet 2. between CalSet 1 and CalSet 2 (as in previous
CalSet 1 counts < CalSet 2 counts for sandwich software versions). But one test independend
assays and additional calibration criteria (minimum acceptable
CalSet 1 counts > CalSet 2 counts for difference) will be added for quantitative assays to
Competitive assays. avoid that the calibration will be released with this
small signal difference between CalSet 1 and CalSet
2.
Calibration reference Reagent packs (unused or partly used) which Reagent packs (used) which have not been
have not been calibrated due to a valid Lot calibrated due to a valid Lot calibration is available,
calibration is available, receive ”new calibration do not change the calibration parameter when a new
parameter” when a new valid Lot calibration is Lot calibration is measured.
measured.
System Pipetting Priorisation 1st Priorisation: Number of determinations in 1st Priorisation: Liquid level detection
the reagent pack 2nd Priorisation: Number of determinations in the
2nd Priorisation: Liquid level detection reagent pack
Manual entered control value 1st priority is the manual entered control value. 1st priority is the manual entered control value, but it
Therefore only when a new control lot is used, is possible to enter this control value reagent lot
the control values are used from the control specific. And therefore when new reagent lot is
barcode card or reagent barcode. scanned in the correct control value is used from the
control barcode card or reagent barcode.
5.8 Calibration factor
Each lot calibration uzilizes a calibration factor 1. The following rackpack calibrations are compared with the last measured lot calibration. The
calibration factor is the ratio between the calibrator signals (difference of CalSet 1 and CalSet 2) of the lot and rackpack calibration.
The calibration factor is only used as a calibration validation criteria and not used for sample calculation.
t1
Calibration factor for each Lot calibration = ____ = 1
t1
CalSet 1 signal (#) - CalSet 2 signal (#)

tl (slope) = _________________________________________
actual CalSet 1l signal - actual CalSet 2l signal
CalSet 1 signal (#) - CalSet 2 signal (#)

tr (slope) = __________________________________________
actual CalSet 1r signal - actual CalSet 2r signal
t1 actual CalSet 1r signal - actual CalSet 2r signal

Calibration factor for Reagent pack calibration = ___ = ____________________________________
tr CalSet 1l signal - CalSet 2l signal
1000 - 22000 counts

Example: Elecsys® TSH = ____________________ = 0.88
1100 - 25000 counts
r = Reagent pack calibration

l = Lot calibration
# calculated via rodbard parameter
This “easy” formula is only valid when the same calibrator concentrations are used for the reagent pack and lot calibration. If the concentrations are differnet
the calibration signals of the standardization have to be considered.
Claudia Schäfer, Global Systems Support April 03
5.9 Recommended assay calibration after a service action
An assay calibration must be carried out for all
• currently used reagent kits as well as for
• the next needed reagent kits
after a service action when there have been changes made or adjustments to the
detection unit.
Exception: When the current RackPack has been on board < 24 hours and the
calibration results in a lot calibration.
To ensure that all needed assay calibrations will be carried out the SCLT Tool
(Software Calibration Liquidation Tool) has been developed to delete all available
assay calibrations after service action.
Then the requested assay calibrations are indicated in the software
Claudia Schäfer, Global Systems Support December 06
6. CONTROL TARGET VALUE (FIRST) ASSIGNMENT
Procedure: 4 instruments, 2 runs each
An actual reagent lot is measured with a new manufactured Roche control. The
control value is written on the control bar code card independent of the reagent lot.
This control value is valid until a specific target value for a reagent lot exists.
Note
If the difference between the medians of the target values for Elecsys® 2010 <
approx. 1 SD (corresponding depending on the assay approx. 5-10%) the mean of
these medians are used as target value.
Reagent lot standardization with/without control target value reassignment
Procedure: 4 instruments, 2 runs each
A reagent will be standardized against the master lot (master reagent and master
calibrator) with all valid calibrators available.
All valid Roche controls are measured and checked for deviations.
Case 1: All controls are within this target range < +/- 1 SD
The target values of the existing control bar code card are used for this reagent lot,
i.e., the control values are not changed when using this reagent lot.
Advantage: The target value of the control is identical.
Disadvantage: The target value of the control is identical, but the recovered value
can have another level within the given range, e.g., 105% for reagent
lot 1 and 94% for reagent lot 2.
Case 2: The controls are out of this target range > +/- 1 SD for this reagent lot
The target values of the controls are on the RackPack bar code, i.e., specific target
values for reagent lots exist and the control values on the control bar code card are
not valid. As a consequence an extra information sheet is put inside the reagent kit
indicating the re-assigned values and the new values are stated on the reagent pack
bar code.
Advantage: The control value will be recovered to about 100%.
Disadvantage: A specific control value for the reagent lot exists.
Notes
Due to the priority rules, the target value of a control will not be taken from the control
barcode card or the reagent barcode for a PreciControl lot –reagent lot combination,
if the target value has been entered manually.for this special PreciControl lot –
reagent lot combination.
Priority 1 Target values of controls put in manually for a special reagent lot.
Priority 2 Target values of controls on the reagent bar code.
Priority 3 Target values of controls on the control bar code card.
That means once a target value of a control is entered manually for a special reagent
lot – PreciControl lot combination, this value is valid for this reagent lot as long as the
customer uses a new reagent lot or a new control lot.
The main point of each standardization action is to receive the same human
serum recovery independent of the reagent lot.
The multi analyte controls are spiked, stripped and preserved and do
unfortunately not always react in the same way.
External/non RD Quality Controls
Biorad Control Values will be assigned with the actual available reagent lot (3
systems, 1 run each, threefold determination) when the Biorad Control is produced,
therefore it will be measured only once per Biorad lot.
Because of this "handling" we do not have experience with Biorad control recovery
deviation when changing reagent lots.
Claudia Schäfer, Global Systems Support July 06

Andreas Sauer, System Qualification
7. ELECSYS® DATA CONCEPT
Connection between RackPack/CalSet/Control/Diluent
Connection via test no. and RP or CalSet lot no. Connection via first two digits of test no. and lot identifier
RackPack <=================================> CalSet Barcode card <=============================> CalSet vial
RackPack Lots which will be produced after the CalSet lot, will have the CalSet lot number printed on the RackPack barcode and so the
connection will be vial CalSet lot number.
CalSet lots which will be produced after the RackPack lot, will have the RackPack lot number printed on the CalSet barcode card and so the
connection will be via RackPack lot number.
Connection via test no. and control lot no. (when there is a reassignment) Conn. via control no. and lot
identifier
RackPack <=============================================> Control Barcode card<==================> Control vial
RackPack lots which will be produced after the Control lot, will have the Control lot number printed on the RackPack barcode when there is a
target values reassignment and so the connection will be via Control lot number.
Connection via test no.
RackPack <===================================================> Diluent
The test number of each assay is stated on the data disk in one file called refer.dat.
(most important) Information printed on the RackPack/CalSet/Control barcode
ReagentPack barcode BCCard/calibrator * Barcode/calibrator vial BCCard/control Barcode/control vial

Test number. Test number 2 digits of the Test number Lot no. Control Control no.
Lot no. Rackpack Lot no. Calibrator Lot ID Lot ID Lot ID
Rackpack bottle no. Lot ID Level no. Control no. Vial number
Lot ID (only for assays Calibrator levels Vial number Expiry Date Control identification
where calibrators are within
the Reagent package)
Place for 5 different Place for 10 different RP Calibrator identification Place for 28 different
calibrator lot target values lots and calibrator target tests (test number,
(only for assays where values target values and
calibrators are not in the ranges in % for
Reagent package) Elecsys® 2010, in SD
for cobas e 411
Place for 10 different control Expiry date
lot target values (for quant.
tests only)
Rodbard Parameter
Calibration validation
criteria
Expiry date
* only for assays where calibrators are not in the reagent package
Claudia Schäfer, Global Systems Support June 2008
8. SOFTWARE INFORMATION
Within GRIPS there is within the document type “Software information” where for the defined system all software issues and hints are
described. It consists of an EXCEL spreadsheet representing the reocrd indwex. Via the index a WORD document contains all record details
and optional attachment files can be opened. All these files are connected via hyperlinks.
As soon as an update of a “software information” is published an e-mail notification is send out to all registered users, when the topic “software
and connectivity is defined“
January 05
9. MARKETING NEWS: THROUGHPUT OF ELECSYS® 2010
Dear colleagues,
The attached information is a summary of our current knowledge about the throughput of
Elecsys 2010 when different combinations of assays are performed.
This information becomes important with the upcoming official launch of Vitamin B12 and
Folate and for further evaluation activities with infectious disease tests.
The information is a summary of information from different evaluations. Please feel free to
copy this information in any format you judge desirable for distribution to your customers.
Frank Willemse
Throughput Elecsys® 2010
The workflow on the Elecsys® 2010 system is completely sample orientated. Due to the
availability of a new disposable tips for each test, there is no risk of contamination. It
becomes possible to perform assays in any sequence, thus allowing samples to be
completed one after the other.
When all assays on the system are ”18 minute assays” the optimal throughput of 88 results
per hour can be reached, producing a result every 42 seconds. In combination with 9 or 27
minute assays, or in combination with 2-step dilution assays, the instrument will slow down,
dependent on the percentage and sequence of tests with other incubation times.
18 minute 9 minute 27 minute
Thyroid TSH, T4, fT4

Tuptake, T3, fT3
Fertility LH, FSH, Prolactin, hCG

Prog, Testo, E2, hCG
Cardiac CK-MB, Troponin T, CK-MB, Troponin T,

Myoglobin, Digoxin Myoglobin
Tumor markers PSA, fPSA, CEA,

AFP, CA 125
Infectious disease HBsAg, anti-HBs, anti-HBc

anti-HBc IgM (*)
Anemia Ferritin Vit B12, Folate
(*) anti-HBc IgM : 18 minute test with 2-step pre-dilution
1. 18 minute tests
Independent of test mixture, the optimal throughput will always be reached. On

Elecsys®2010 Disk there might be short periods of throughput slow-down, due to the loading
of a new sample disk. On Elecsys® 2010 Rack such ”gaps” should not exist, because of the
continuous loading philosophy with universal Hitachi racks.
Typical throughput Elecsys 2010 disk Typical throughput Elecsys 2010 rack
300 300
250  250

200 200

150 150

100 100
50  Disk system
50
Rack system
Theoretical Theoretical
0 0
0:00:00 1:00:00 2:00:00 3:00:00 4:00:00 0:00:00 1:00:00 2:00:00 3:00:00 4:00:00
 = sample disk change  = waste exchange  = waste exchange
All 18 minute tests follow the same time-protocol. Therefore, there will be no timing conflicts.
The Elecsys® 2010 will perform in one 42 second time cycle simultaneously
S1 (1st pipetting), S2 (2nd pipetting) and D (detection).
S1 (1st pipetting step)
S2 (2nd pipetting step)
D (detection)
2. Mixture of 9 and 18 minute tests
The throughput of Elecsys® 2010 depends on the percentage and distribution of the 9 minute
tests. As a limiting factor it is not possible during one 42 second cycle to plan the detection of
2 tests. When scheduling the first pipetting of a 9 minute assay, the system has to be sure to
have an open cycle for detection 9 minutes later. Dependent on the percentage and
distribution of the 9 minute assays, throughput can be influenced or not.
D (detection)
Idle cycles - throughput reduction
Throughput reduction !
If the number of requested 9 minute assays is very small, bigger ”THROUGHPUT GAPS” will
exist (second part of below graph).
200
180
160
Number of results produced
140
120
100
80
60
THEORETICALOUTPUT
40
Mix of 9and 18 min tests
20 Only 18 min tests
0
0 0.5 1 1.5 2 2.5 3 3.5 4
Operationtime (inhours)
3. 27 minute tests
If only 27 minute assays are performed, the throughput of Elecsys® 2010 is reduced to 44
results per hour. Every 13 cycles, the Elecsys® 2010 comes into a timing problem. It is not
possible to perform within one 42 second cycle a S0 (pretreatment pipetting) together with a
S1 (first reagent pipetting). The instrument will stand for 13 cycles (9 minutes) until it is
possible again to pipette without conflict.
S0 (pretreatment pipetting)
D (detection)
Internal Evaluation Elecsys® 2010 Racksampler SW03-04

Comparison of Throughput "18- & 27- min Assays"
200
180
160
140
results produced
120
100
80
60
40 Only 18 min assays
20 Only 27 minute assays
0
00:00
00:15
00:30
00:45
01:00
01:15
01:30
01:45
02:00
02:15
02:30
02:45
03:00
03:15
03:30
03:45
04:00
operation time [h*min]
4. Mixture of 18 and 27 minute tests
When mixing 18 and 27 minute assays, it depends on the assay-mix and on the exact test
sequence, how many gaps are created. The ”gaps” can vary from 1 to 13 idle cycles (42
seconds to 9 minutes). Limiting factors are that only 1 detection can take place during one 42
second cycle and that pretreatment step (S0) can not be combined with first reagent pipetting
(S1). In below example of 20% random distribution of 27 minute assays, the throughput is
reduced with 16.6% (5 cycles on 30 results).
S0 (pretreatment pipetting)

| |
| | S2 (2nd pipetting step)
| |
| | D (detection)
| |
| | Idle cycles - throughput reduction
| |
| |
| | | |
| | | |
| | | |
| |
| | |
| | |
| | |
| | |
| | | |
, | | | |
| |
| |
| |
| |
|
|
|
Following data from the internal evaluation show the decrease in throughput, dependent on
the distribution of 18 and 27 minute tests.
Internal Evaluation Elecsys® 2010 Rack Sampler SW 03-04

Comparison of Throughput "18- & 27- min Assays"
18:27 [min]
300
Only 18 min assays
280
18 min Assays
260 4:1
240 27 min Assays
220 18 min Assays

3:1
res200
ult 27 min Assays
s 180
pro 18 min Assays
du 160 2:1
ce
27 min Assays
d 140
120 18 min Assays
1:1
100
27 min Assays
80
18 min Assays
60 1:2
40 27 min Assays
20 Only 27 minute
assays
0 00: 00: 00: 00: 01: 01: 01: 01: 02: 02: 02: 02: 03: 03: 03: 03: 04: 04: 04: 04: 05:
00 15 30 45 00 15 30 45 00 15 30 45 00 15 30 45 00 15 30 45 00
operation time [h*min]
10. ELECSYS® 2010 MEASURING PRINCIPLE
11. TECHNICAL INFORMATION/FLOW CHARTS
11.1 Run preparation
Flow Chart of Run Preparation
Start
No
First order ?
Yes
Mechanical units reset
Were reagents
exchanged ?
No
Yes
Counting tips
Reagent barcode scan and vessels
PC/CC
volume
90 min or more Clearing the check
passed since last incubator
Inventory mixing ? No and the T/V
sending to buffer
the host Yes
computer Beads mixing
Alarm:
Inventory OK? Inventory
Short
Short(something)
Enough 45-xx-01
Scheduling Preparation cycle
First pipetting
First sipping
Pipetting is continuing
Resume Cycle
Sipping is continuing
Flow Chart of Preparation Cycle
Preparation cycle start
Preparation 1
(Flowing PC/CC without
voltage)
Preparation 3-1
(Flowing PC/CC with
voltage)
Preparation 3-2
(Flowing PC/CC with
voltage)
Preparation 3-3
(Flowing PC/CC with voltage
and AB current/count check)
End
Flow Chart of Count / Current Range check
Count/Current
Check Start
Attach Flag 41 or 43
to all measurements.
Alarm; PC/CC LLD It depends on the
PC LLD ? Fail 37-05-01 timing the alarm
occured that which
OK
flag will be attached.
PC luminescence Alarm; PC level Attach Flag 40 to all

count check ? range over 31-02-01 measurements
Range over
OK
Alarm; PC current Attach Flag 42 to all

PC current check ? range over 31-02-02 measurements
Range over
OK
End
11.2 Resume
Flow Chart of Resume Cycle
Resume cycle start
Are there any cycles without

determinations (Idle time) ?
No
Yes
After Cycle switch off potentiostat
Yes
13 cycles or more ?
No
Yes
Swich on potentiostat Swich on potentiostat
3 Resume cycle 1 Resume cycle

Resume: (=Prepare 3) (Resume = Prepare 3)
Next determination
(starts direct after resume)
End
11.3 Finalization
Flow Chart of Finalisation
Last sipping
10 cycles waiting for the new oder* *10 cycles for Disk system
10 cycles for RS
60 cycles for RC
40 cycles for Disk since 7/E version
Finalization 40 cycles for RS since 7/E version
Gripper moves to home

position
Pipetter prime Sipper flow cleaning

with the system water
Inventory Sipper prime

sending to the 3 layered
host computer pipetter?
No
Filling the MC
Yes with the PC
Pipetter end wash

Filling the
sipper nozzle
with water
Stand by
11.4 LFC
Elecsys 2010 Flow Chart of

Liquid Flow Cleaning Customer/Servic
Set Adaptor on the position
Fill in ISE-Solution
Input N, repeat times

(1 <=Ν<= 3)
Press a button to start cleaning
Y = X+10 (N-1)
Sipper move down Y mm
N = repeat times
X = fixed Aspirate 2.5 ml, 150 μl/s ISE-Solution
Aspirate 2.5 ml, 150 μl/s ISE-Solution

Repeat N times
Incubate 6 min.
Aspirate 2.5 ml, 150 μl/s ISE-Solution

(Scrub wash)
Sipper Prime
Preparation 1 (without voltage) x 3
Preparation 2 (with voltage) x 3
Finalization
Standby
11.5 LLD Pipettor
Elecsys 2010 Disk/Rack Version

Flow Chart of Pipettor LLD
LLD and Z motor down Start;

12.8 mm (100 ms) getting Vave
Yes Alarm; Hovering (environment 1)

V>4.5 V ? when
35-01-06, 37-xx-06
No
Bright
Alarm
Abnormal descnet sensor ? when Z motor stops
Pipetttor Z 16-02-05
Dark
Yes Alarm; Hovering (environment 2)
dV<=dV th and V>=4.5 V? when
35_01-07, 37_xx_07
No
Remained pulse = 0 ? when

Yes Alarm ; something (liquid) LLD
Z motor stops
Pipetttor Z 16-02-05
No
No
dV >= dV th ? when
Yes
V>= V ref during 6 ms (noise) ? when

NG
OK
Z-motor stops
Alarm ; Hovering (Mistake)

V>V ref during 150 ms (el. st.) ? when
NG
35-01-05, 37-xx-05
OK
Liquid type ? Height check ? Alarm ; Film detected, 37_xx_04

Reagent Same
Sample or Calibrator OK as Cap
Alarm ; something liquid short
Remained pulse = 0 ? when
Yes
35-01-02, 37-xx-02
No
Liquid type ?
Reagent
Sample or Calibrator
Sucking, Z motor
Sucking starts
down and CD start
NG
Pressure check ? when Alarm ; Clot detected, 49-01-01
OK
Sucking end; Z motor down stops
11.6 LLD Sipper
Elecsys 2010 Disk/Rack Version

Flow Chart of Sipper LLD
LLD and Z motor down Start;

12.8 mm (100 ms)
No Bright
Alarm
Abnormal descnet senor ? when Z motor stops
Sipper Z 20-02-05
Dark
Remained pulse = 0 ? when Yes Alarm ; PC/CC LLD

Z motor stops
37-05-01; Bottle 1 and 2
No 37-05-02; Bottle 1 or 2
37-05-02 + Flag 43 => Stop
dV >= dV th ? when
No
Yes
V>= V ref during 3 ms (noise) ? when

NG
OK
Z-motor stops
V>V ref during 20 ms ? when
OK
Remained pulse = 0 ? when Alarm ; PC/CC short

Yes 37_05_03
No
Were the PC/CC

Are the PC/CC Alarm ; System reagents
bottles set before 15
volume 100% ? when 36-05-01; Pos 1 (Flag 44)
min or longer ? when No Yes
36-05-02; Pos 2 (Flag 44)
Yes
36-05-05; Pos 1 and 2 (Flag
44) => Stop
No
Sucking ends, Z
motor down stops
dV th (V) = 0.09 V rev (V) = 0,04
Dr. G. Müller, LP-DR,  08158-224335;  08158-224036
11.7 Liquid Flow Tubings 3
Valve Block
MC
System Water Circulation
17
Liquid Flow System 15
SV3 SV4
Waste Tubing/Modification 0
18
T Parts Name Parts No Material
Line Heater
No 9
8
0 Tube 0 741-0996 19
1 Tube 1 741-0807
16
2 Tube 2 741-0808
3 Sipper Drain Tube G153001 Tygon R3606
4 Drain Tube Cleaning Basth (S) G153025 Silicon Rubber
5 Water Tube for M Rod G153001 Tygon R3606 Sipper Syringe

S/P RS 1
2
6 Water Tube for P Prove G153001 Tygon R3606 Sipper RS
4
7 Tube 7 741-0809
8 Tube 8 741-0543
7
5
SV1/2/7/5/6
14
Waste
12/13 Modification
System Water
6 Liquid Waste
10
Pump
b-TroubleshootingElecsys2010v53.doc-SC 11 Filter
12. FREQUENTLY ASKED QUESTIONS
Question Answer Remarks
Why could it be Due to Elecsys® Universal Diluent is one bottle only, it is Therefore we would recommend to inform
possible that an possible that the diluent is not correct placed on the reagent your customer that the Elecsys® Universal
auto dilution is not rotor that means instead of the Elecsys® 2010 barcode will Diluent RackPack should be placed very
possible any more, be used the E 170 module for MODULAR ANALYTICS carefully that the Elecsys® 2010 barcode
although a bottle barcode. And then it is not possible to use this diluent for and not the E 170 module for MODULAR
Elecsys® Universal auto dilution on Elecsys® 2010, due to the needed Elecsys® ANALYTICS barcode will be used. The
Diluent is on test number is not available but the Application Code barcode reader of Elecsys® 2010 is outside
board? number for E 170 module for MODULAR ANALYTICS. In the reagent rotor, whereas the barcode
case that the first RackPack of the Elecsys® Universal reader of E 170 for MODULAR
Diluent Lot is not placed correctly, it is not possible to use ANALYITCS is inside the reagent rotor.
another RackPack of the same Elecsys® Universal Diluent
again, due to if the same lot number will scanned, the
information will be used from the data base.
What to do when a Please repeat within the next 24 hours with the same If the calibration is repeated > 24 hours, it
„bad“ calibration reagent pack a „good“ calibration e.g. with new CalSets on is possible that the RackPack calibration is
was released as lot Elecsys® 2010. Then the „bad“ calibration is overwritten and not released because of the calibration
calibration on not available any more. factor. It is also possible to carry out a new
Elecsys® 2010? lot calibration with another reagent pack.
Then this reagent pack with the „bad“
calibration can be calibrated again. The
RackPack calibration refers with the
calibration factor to the latest released lot

calibration, therefore no problems with the
calibration factor is expected.
What could be the We would like to inform you that starting with software
reason when flag version 06-x for each determination an effective signal check
58 signal level is carried out to improve the system reliability (flag 58 signal
below limit appears level below limit). In the Operators Manual is the remedy
for competitive "rerun the sample". But please note that if an extremely high
assays? sample concentration is measured for a competitive assay,
this result will also be flagged. This can easily be checked
by the dilution of the sample. Therefore please rerun the
diluted sample. When a new version of Operators Manual
will be introduced, the remedy "rerun diluted sample" will be
added.
What has to be Please check the unit, because for the instrument is this a new assay. That means when the customer
considered when an does not use the default unit, the unit has to be adapted. In addition possibly a new CalSet, Control and
improved test with Diluent has to be used, where the new test number is corresponding.
new test number is
used?
What has to be Please use the default unit when the intercept is used as instrument factor, even when the customer
considered when an does not use the intercept.
instrument factor is
used?
What is the dead The dead volume in the CalSet and Control vials is 250 µl for software version 03-x, but 150 µl for the
volume in the software version 06-x.
CalSet vials for
software version
03-x and 06-01
(final software)?

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2. ELECSYS® 2010 TROUBLESHOOTING PROPOSAL 6

5. ELECSYS® 2010 ASSAY CALIBRATION 104

7. ELECSYS® DATA CONCEPT 120

8. SOFTWARE INFORMATION 122

10. ELECSYS® 2010 MEASURING PRINCIPLE 129

11. TECHNICAL INFORMATION/FLOW CHARTS 131

12. FREQUENTLY ASKED QUESTIONS 140

CHANGES IN THE DIFFERENT VERSIONS:

2.8 Updates of chapter 3.1/3.2/ 3.5/ 3.6/5.5/5.6/5./8/12

1. TROUBLE SHOOTING GUIDE ELECSYS® SYSTEMS: QUICK INFO

Information needed in case of an Elecsys® customer complaint

In most cases, it is not easy to identify whether the

 reagent kit / calibrator / control

is the reason for the customer complaint.

Therefore, it is necessary to get as much information as possible, e.g. as described

• A clear description of the problem/phenomena/case:

 Problem observed with all or just one assay?

 Problem observed with all systems or with one system?

 Problem observed with all or just one serum?

• All case-related reagent lots

 reagent kit, calibrators, controls, ProCell, CleanCell, disposables, SysWash

• All case-related results

 patients incl. patient history, QC, calibrators, calibrator signal level

• Details concerning "reagent handling"

 calibration frequency, control handling, etc.

• Type of instrument, software version ect.

In the case of recovery or precision problems, we recommend analyzing the

1. Check the “reagent handling” at customer site

2) Check the instrument

3) If neither of these points are the reason, the

Claudia Schäfer, Global Customer Support August 2010

2. ELECSYS® 2010 TROUBLESHOOTING PROPOSAL

2.2 Complaints concerning drift Possible causes Actions/Prevention

2.3 Complaints concerning Possible causes Actions/Prevention

2.3 Complaints concerning Possible causes Actions/Prevention

2.3 Complaints concerning Possible causes Actions/Prevention

• Recovery in method comparisons.

Please check calibration counts.

2.4 Complaints concerning Possible causes Actions/Prevention

2.5 Complaints concerning intra Possible causes Actions/Prevention

2.6 Complaints concerning inter Possible causes Actions/Prevention

2.7 Complaints concerning Possible causes Actions/Prevention

2.8 Complaints concerning system to Possible causes Actions/Prevention

C. Schäfer, Global Customer Support August 10

Please note that the signal hight can differ

Reagent type Test CalSet 1 CalSet 1 CalSet 2 CalSet 2

Reagent type Test CalSet 1 CalSet 1 CalSet 2 CalSet 2

Reagent type Test CalSet 1 CalSet 1 CalSet 2 CalSet 2

C. Schäfer, Global Customer Support August 2011

Elecsys 2010 ®Assays

Elecsys 2010 ®Assays

Elecsys 2010 ®Assays

Assay Measuring Reference LDL Reagent Reagen Reagent Dilution Reference

Elecsys 2010 ®Assays

Assay Measuring Reference LDL/LoD Reagent Reagent Reagent Dilution Reference

* Please check in package insert.

Elecsys 2010 ®Assays

Assay Measuring Reference LDL Reagent Reagen Reagent Dilution Reference

Elecsys 2010 ®Assays

Elecsys 2010 ®Assays

Elecsys 2010 ®Assays

* Please check in package insert.