Claudia Schäfer, CIR, Penzberg,  4486

October 2014
sig2010.doc

Dear Colleagues,
Please find below a table of the mean assay calibration signals observed on Elecsys® 2010 / 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)
* 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.

1

Version 7.0

25 nmol/l ≈ 50 nmol/l ≈ 0 µIU/ml ≈ 0.5 mIU/ml ≈ 1 mIU/ml ≈ 0. Penzberg.5 nmol/l ≈ 230 nmol/l ≈ 1.doc Elecsys® 2010 / cobas e 411 Assay Calibration (mean observed signals) Reagent type Test Thyroid Function Test FT3 III FT4 II T3 T4 TSH T-uptake Calcitonin Tg II Anti-Tg Anti-TPO Anti-TSHR CK-MB STAT Digoxin Digitoxin Myoglobin STAT proBNP II Troponin I STAT Troponin T STAT hs ACTH AMH Cortisol DHEAS Estradiol II FSH HCG STAT HCG+β LH Progesterone II Prolactin II SHBG Cardiac Hormones Testosterone II CalSet 1 signal (counts) ≈ 130 000 ≈ 100 000 ≈ 320 000 ≈ 370 000 ≈ 700 ≈ 75 000 ≈ 2 500 ≈ 3 000 ≈ 500 000 ≈ 300 000 ≈ 80 000 ≈ 2 500 ≈ 80 000 ≈ 125 000 ≈ 3 300 ≈ 3 800 ≈ 1 500 ≈ 1 500 ≈ 1 700 ≈ 2 200 ≈ 100 000 ≈ 150 000 ≈ 90 000 ≈ 7 000 ≈ 3 200 ≈ 1 500 ≈ 2 500 ≈ 150 000 ≈ 650 ≈ 2 000 CalSet 1 concentration ≈ 2 pmol/l ≈ 10 pmol/l ≈ 1. CIR.Claudia Schäfer.5 µIU/ml ≈ 1.5 ng/ml 2 Version 7.61 ng/ml ≈ 5 ng/ml ≈ 33 ng/ml ≈ 140 pg/ml ≈ 0.61 ng/ml ≈ 60 ng/ml ≈ 1300 ng/ml ≈ 2700 pg/ml ≈ 30 ng/ml ≈ 4 200 ng/l ≈ 120 pg/ml ≈ 8 ng/mL ≈ 1000 nmol/l ≈ 750 µg/dl ≈ 5300 pg/ml ≈ 55 mIU/ml ≈ 5 000 mIU/ml ≈ 2 000 mIU/ml ≈ 45 mIU/ml ≈ 53 ng/ml ≈ 2 000 µU/ml ≈ 40 nmol/l ≈ 70 000 ≈ 0.0 .04 ng/mL ≈ 12.1 TBI ≈ 500 pg/ml ≈ 180 ng/ml ≈ 3 250 IU/ml ≈ 350 IU/ml ≈ 25 IU/l ≈ 25 ng/ml ≈ 3.15 ng/ml ≈ 40 IU/ml ≈ 35 IU/ml ≈ 1 IU/l ≈ 1.5 nmol/l ≈ 5 µg/dl ≈ 20 pg/ml ≈ 1 mIU/ml ≈ 10 mIU/ml ≈ 1.25 TBI ≈ 2 pg/ml ≈ 0.4 ng/ml ≈ 6 500 ≈ 11.4 ng/ml ≈ 18 ng/l ≈ 15 pg/ml ≈ 0.5 ng/ml ≈ 0.  4486 October 2014 sig2010.2 ng/ml ≈ 2 µU/ml ≈ 0 nmol/l CalSet 2 signal (counts) ≈ 11 000 ≈ 20 000 ≈ 100 000 ≈ 150 000 ≈ 27 000 ≈ 135 000 ≈ 420 000 ≈ 950 000 ≈ 30 000 ≈ 140 000 ≈ 13 000 ≈ 35 000 ≈ 27 000 ≈ 35 000 ≈ 220 000 ≈ 70 000 ≈ 80 000 ≈ 400 000 ≈ 12 000 ≈ 240 000 ≈ 15 000 ≈ 25 000 ≈ 9 000 ≈ 280 000 ≈ 900 000 ≈ 550 000 ≈ 100 000 ≈ 5 000 ≈ 270 000 ≈ 100 000 CalSet 2 concentration ≈ 40 pmol/l ≈ 45 pmol/l ≈ 8.

Claudia Schäfer. CIR.05 ng/ml ≈ 0 ng/ml ≈ 0 ng/ml ≈ 0.1 mIU/ml ≈ 0 ng/ml ≈ 20 pg/ml ≈ 0.1 pg/ml ≈ 25 µg/l ≈ 2 ng/ml ≈ 1 IU/ml ≈ 20 U/ml 3 CalSet 2 signal (counts) ≈ 900 000 ≈ 220 000 ≈ 140 000 ≈ 450 000 ≈ 55 000 ≈ 140 000 ≈ 80 000 ≈ 100 000 ≈ 75 000 ≈ 25 000 ≈ 50 000 ≈ 200 000 ≈ 100 000 ≈ 240 000 ≈ 600 000 ≈ 40 000 ≈ 45 000 ≈ 550 000 ≈ 300 000 ≈ 4 500 ≈ 75 000 ≈ 13 000 ≈ 10 000 ≈ 25 000 ≈ 100 000 ≈ 1 300 000 ≈ 280 000 ≈ 25 000 ≈ 300 000 ≈ 60 000 ≈ 125 000 ≈ 190 000 CalSet 2 concentration ≈ 20 ng/ml ≈ 300 µU/ml ≈ 1 200 pg/ml ≈ 15 000 pg/ml ≈ 50 U/ml ≈ 500 U/ml ≈ 100 U/ml ≈ 250 U/ml ≈ 70 U/ml ≈ 50 ng/ml ≈ 50 ng/ml ≈ 200 pmol/l ≈ 50 ng/ml ≈ 20 ng/ml ≈ 60 ng/ml ≈ 294 pg/ml ≈ 2 ng/ml ≈ 64 IU/l ≈ 2 500 mIU/l ≈ 1 500 pg/ml ≈ 300 ng/ml ≈ 17 ng/ml n/a ≈ 2 ng/ml ≈ 10 ng/ml ≈ 280 ng/ml ≈ 4500 pg/ml ≈ 420 pg/ml ≈ 850 µg/l ≈ 45 ng/ml ≈ 100 IU/ml ≈ 200 U/ml Version 7.05 pg/ml ≈ 0. Penzberg.5 ng/ml ≈ 5 µU/ml ≈ 5 pg/ml ≈ 0 pg/ml ≈ 5 U/ml ≈ 35 U/ml ≈ 15 U/ml ≈ 20 U/ml ≈ 1 U/ml ≈ 5 ng/ml ≈ 5 ng/ml ≈ 5 pmol/l ≈ 0.0 .doc Reagent type Test Diabetes C-Peptide Insulin PlGF sFlt-1 AFP CA 125 II CA 15-3 II CA 19-9 CA 72-4 CEA Cyfra 21-1 HE4 NSE Free PSA Total PSA ProGRP S100 Free ßhCG PAPP-A Vitamin B12 Ferritin Folate III Folate RBC β-CrossLaps hGH N-MID Osteocalcin PTH STAT PTH (1-84) total P1NP Vitamin D total IgE II Anti-CCP Preeclampsia Tumor Marker Down’s syndrome screening Anaemia Bone Varia Rheumatoid Arthritis CalSet 1 signal (counts) ≈ 12 000 ≈ 5 500 ≈ 2 000 ≈ 750 ≈ 8 000 ≈ 10 000 ≈ 13 000 ≈ 10 000 ≈ 3 500 ≈ 3 000 ≈ 800 ≈ 4 000 ≈ 2 000 ≈ 1 800 ≈ 600 ≈ 3 300 ≈ 2 000 ≈ 10 000 ≈ 8 000 ≈ 20 000 ≈ 3 200 ≈ 70 000 ≈ 65 000 ≈ 2 000 ≈ 900 ≈ 1 000 ≈ 1 000 ≈ 800 ≈ 10 000 ≈ 180 000 ≈ 3 500 ≈ 3 000 CalSet 1 concentration ≈ 0.2 ng/ml ≈ 1 IU/l ≈ 75 mIU/l ≈ 100 pg/ml ≈ 10 ng/ml ≈ 4 ng/ml n/a ≈ 0.  4486 October 2014 sig2010.5 ng/ml ≈ 0.

collected by the QC department. 4 Version 7.Claudia Schäfer.1 ng/ml ≈ 18 pg/ml ≈ 30 ng/ml ≈ 1 ng/ml negative negative negative negative negative negative ≈ 10 IU/l negative negative negative negative CalSet 2 signal (counts) ≈ 640 000 ≈ 50 000 ≈ 23 000 ≈ 35 000 ≈ 3 000 ≈ 10 000 ≈ 400 ≈ 40 000 ≈ 3 000 ≈ 70 000 ≈ 45 000 ≈ 6 000 ≈ 5 500 ≈ 70 000 ≈ 35 000 CalSet 2 concentration ≈ 54 ng/ml ≈ 700 pg/ml ≈ 1 600 ng/ml ≈ 30 ng/ml ≈ 40 IU/l positive positive positive positive positive ≈ 450 IU/l positive ≈ 5 IU/ml positive positive ≈ 2 300 ≈ 1 400 ≈ 700 ≈ 1 000 ≈ 900 ≈ 5 000 ≈ 1 600 ≈ 10 000 ≈ 900 ≈ 1 300 ≈ 1 100 ≈ 1 200 negative negative negative negative negative negative negative negative negative negative negative negative ≈ 40 000 ≈ 55 000 ≈ 150 000 ≈ 200 000 ≈ 7 000 ≈ 115 000 ≈ 95 000 ≈ 300 000 ≈ 9 000 ≈ 280 000 ≈ 280 000 ≈ 11 000 positive positive ≈ 40 U/ml ≈ 40 U/ml positive positive positive ≈ 400 IU/ml ≈ 700 U/ml ≈ 100 IU/ml ≈ 100 IU/ml ≈ 130 U/ml .  4486 October 2014 sig2010.0 . CIR.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.doc Reagent type Test Sepsis BRAHMS PCT IL-6 Cyclosporine Tacrolimus Anti-HAV Anti-HAV IgM Anti-HBc Anti-HBc IgM Anti-HBe HBeAg Anti-HBs HBsAg II HBsAg II quant Anti-HCV II HIV Ag ISDs Hepatitis Sexually Transmitted Diseases (STD) Torch HIV combi PT Syphilis CMV IgG CMV IgG Avidity CMV IgM HSV-1 IgG HSV-2 IgG Rubella IgG Rubella IgM Toxo IgG Toxo IgG Avidity Toxo IgM CalSet 1 signal (counts) ≈ 1 700 ≈ 2 500 ≈ 230 000 ≈ 250 000 ≈ 30 000 ≈ 750 ≈ 140 000 ≈ 1 500 ≈ 650 000 ≈ 600 ≈ 1 800 ≈ 1 000 ≈ 900 ≈ 1 000 ≈ 750 CalSet 1 concentration ≈ 0. Penzberg.