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Claudia Schfer, CIR, Penzberg,4486 October 2014sig2010.doc

Version 7.02

Elecsys 2010 / cobas e 411Assay Calibration (mean observed signals)

Reagent type Test CalSet 1

signal (counts)

CalSet 1

concentration

CalSet 2

signal (counts)

CalSet 2

concentration

Thyroid Function FT3 III 130 000 2 pmol/l 11 000 40 pmol/l

Test FT4 II 100 000 10 pmol/l 20 000 45 pmol/l

T3 320 000 1.25 nmol/l 100 000 8.5 nmol/l

T4 370 000 50 nmol/l 150 000 230 nmol/l

TSH 700 0 IU/ml 27 000 1.5 IU/ml T-uptake 75 000 0.25 TBI 135 000 1.1 TBI

Calcitonin 2 500 2 pg/ml 420 000 500 pg/ml

Tg II 3 000 0.15 ng/ml 950 000 180 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 80 000 1 IU/l 13 000 25 IU/l

Cardiac CK-MB STAT 2 500 1.5 ng/ml 35 000 25 ng/ml

Digoxin 80 000 0.61 ng/ml 27 000 3.61 ng/ml

Digitoxin 125 000 5 ng/ml 35 000 60 ng/ml Myoglobin STAT 3 300 33 ng/ml 220 000 1300 ng/ml

proBNP II 3 800 140 pg/ml 70 000 2700 pg/ml

Troponin I STAT 1 500 0.4 ng/ml 80 000 30 ng/ml

Troponin T STAT hs 1 500 18 ng/l 400 000 4 200 ng/l

Hormones ACTH 1 700 15 pg/ml 12 000 120 pg/ml

AMH 2 200 0.04 ng/mL 240 000 8 ng/mL

Cortisol 100 000 12.5 nmol/l 15 000 1000 nmol/l

DHEAS 150 000 5 g/dl 25 000 750 g/dl

Estradiol II 90 000 20 pg/ml 9 000 5300 pg/ml

FSH 7 000 1 mIU/ml 280 000 55 mIU/ml

HCG STAT 3 200 10 mIU/ml 900 000 5 000 mIU/ml

HCG+ 1 500 1.5 mIU/ml 550 000 2 000 mIU/ml

LH 2 500 1 mIU/ml 100 000 45 mIU/ml

Progesterone II 150 000 0.2 ng/ml 5 000 53 ng/ml

Prolactin II 650 2 U/ml 270 000 2 000 U/ml

SHBG 2 000 0 nmol/l 100 000 40 nmol/l

Testosterone II70 000 0.4 ng/ml 6 500 11.5 ng/ml


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Version 7.03

Reagent type Test CalSet 1signal (counts)

CalSet 1concentration

CalSet 2signal (counts)

CalSet 2concentration

Diabetes C-Peptide 12 000 0.5 ng/ml 900 000 20 ng/ml Insulin 5 500 5 U/ml 220 000 300 U/ml

Preeclampsia PlGF 2 000 5 pg/ml 140 000 1 200 pg/ml

sFlt-1 750 0 pg/ml 450 000 15 000 pg/ml

Tumor Marker AFP 8 000 5 U/ml 55 000 50 U/ml

CA 125 II 10 000 35 U/ml 140 000 500 U/ml

CA 15-3 II 13 000 15 U/ml 80 000 100 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 3 000 5 ng/ml 25 000 50 ng/ml

Cyfra 21-1 800 5 ng/ml 50 000 50 ng/ml

HE4 4 000 5 pmol/l 200 000 200 pmol/l

NSE 2 000 0.5 ng/ml 100 000 50 ng/ml

Free PSA 1 800 0.1 mIU/ml 240 000 20 ng/ml

Total PSA 600 0 ng/ml 600 000 60 ng/ml

ProGRP 3 300 20 pg/ml 40 000 294 pg/ml

S100 2 000 0.2 ng/ml 45 000 2 ng/mlDowns syndrome Free hCG 10 000 1 IU/l 550 000 64 IU/l

screening PAPP-A 8 000 75 mIU/l 300 000 2 500 mIU/l

Anaemia Vitamin B12 20 000 100 pg/ml 4 500 1 500 pg/ml

Ferritin 3 200 10 ng/ml 75 000 300 ng/ml

Folate III 70 000 4 ng/ml 13 000 17 ng/ml

Folate RBC 65 000 n/a 10 000 n/a

Bone -CrossLaps 2 000 0.05 ng/ml 25 000 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 1 000 0.05 pg/ml 280 000 4500 pg/ml

PTH (1-84) 800 0.1 pg/ml 25 000 420 pg/ml

total P1NP 10 000 25 g/l 300 000 850 g/l

Vitamin D total 180 000 2 ng/ml 60 000 45 ng/ml

Varia IgE II 3 500 1 IU/ml 125 000 100 IU/ml

Rheumatoid Arthritis Anti-CCP 3 000 20 U/ml 190 000 200 U/ml


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Version 7.04

Reagent type Test CalSet 1signal (counts) CalSet 1concentration CalSet 2signal (counts) CalSet 2concentration

Sepsis BRAHMS PCT 1 700 0.1 ng/ml 640 000 54 ng/ml

IL-6 2 500 18 pg/ml 50 000 700 pg/ml

ISDs Cyclosporine 230 000 30 ng/ml 23 000 1 600 ng/ml

Tacrolimus 250 000 1 ng/ml 35 000 30 ng/ml

Hepatitis Anti-HAV 30 000 negative 3 000 40 IU/l

Anti-HAV IgM 750 negative 10 000 positive

Anti-HBc140 000

negative 400

positive

Anti-HBc IgM 1 500 negative 40 000 positive

Anti-HBe 650 000 negative 3 000 positive

HBeAg 600 negative 70 000 positive

Anti-HBs 1 800 10 IU/l 45 000 450 IU/l

HBsAg II 1 000 negative 6 000 positive

HBsAg II quant 900 negative 5 500 5 IU/ml

Anti-HCV II 1 000 negative 70 000 positive

Sexually TransmittedDiseases (STD)

HIV Ag750

negative 35 000

positive

HIV combi PT 2 300 negative 40 000 positive

Syphilis 1 400 negative 55 000 positive

Torch CMV IgG 700 negative 150 000 40 U/ml

CMV IgG Avidity 1 000 negative 200 000 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 10 000 negative 300 000 400 IU/ml

Rubella IgM 900 negative 9 000 700 U/ml

Toxo IgG 1 300 negative 280 000 100 IU/ml

Toxo IgG Avidity 1 100 negative 280 000 100 IU/ml

Toxo IgM 1 200 negative 11 000 130 U/ml

-no informationThe 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.

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