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Claudia Schfer, 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.

Version 7.0

Claudia Schfer, CIR, Penzberg, 4486

October 2014
sig2010.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+
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
1.25 nmol/l
50 nmol/l
0 IU/ml
0.25 TBI
2 pg/ml
0.15 ng/ml
40 IU/ml
35 IU/ml
1 IU/l
1.5 ng/ml
0.61 ng/ml
5 ng/ml
33 ng/ml
140 pg/ml
0.4 ng/ml
18 ng/l
15 pg/ml
0.04 ng/mL
12.5 nmol/l
5 g/dl
20 pg/ml
1 mIU/ml
10 mIU/ml
1.5 mIU/ml
1 mIU/ml
0.2 ng/ml
2 U/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
8.5 nmol/l
230 nmol/l
1.5 IU/ml
1.1 TBI
500 pg/ml
180 ng/ml
3 250 IU/ml
350 IU/ml
25 IU/l
25 ng/ml
3.61 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 g/dl
5300 pg/ml
55 mIU/ml
5 000 mIU/ml
2 000 mIU/ml
45 mIU/ml
53 ng/ml
2 000 U/ml
40 nmol/l

70 000

0.4 ng/ml

6 500

11.5 ng/ml

Version 7.0

Claudia Schfer, CIR, Penzberg, 4486

October 2014
sig2010.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 hCG
PAPP-A
Vitamin B12
Ferritin
Folate III
Folate RBC
-CrossLaps
hGH
N-MID Osteocalcin
PTH STAT
PTH (1-84)
total P1NP
Vitamin D total
IgE II
Anti-CCP

Preeclampsia
Tumor Marker

Downs 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
0.5 ng/ml
5 U/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
0.5 ng/ml
0.1 mIU/ml
0 ng/ml
20 pg/ml
0.2 ng/ml
1 IU/l
75 mIU/l
100 pg/ml
10 ng/ml
4 ng/ml
n/a
0.05 ng/ml
0 ng/ml
0 ng/ml
0.05 pg/ml
0.1 pg/ml
25 g/l
2 ng/ml
1 IU/ml
20 U/ml

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 U/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 g/l
45 ng/ml
100 IU/ml
200 U/ml

Version 7.0

Claudia Schfer, CIR, Penzberg, 4486

October 2014
sig2010.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
0.1 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

- 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.

Version 7.0