estabilidades y cv e411

Elecsys 2010 / cobas e 411 Assays / CalSets / Controls
Assay Measuring Reference range LDL/LoB Reagent Reagent Reagent Dilution Reference material or
Cat.no. range (functional stability stability stability on (conc. of Reference method
(total duration in sensitivity/ unopened opened board diluted sample /Standardisation
min.) LoQ, if 2-8C 2-8C must be)
[competitive/ available)
sandwich assay]
FT3 III 0.400-50.00 * 0.400 pmol/l Expiry date 12 weeks 6 weeks  Elecsys FT3 (this in turn
06437206 pmol/l was calibrated using
(18)[c] equilibrium dialysis)
FT4 II 0.300-100.0 12-22 pmol/l 0.30 pmol/l Expiry date 12 weeks 4 weeks  Elecsys FT4 (this in turn
06437281 pmol/l * was calibrated using
(18)[c] Enzymun-Test FT4, this in
turn was calibrated using
equilibrium dialysis)
T3 0.300-10.00 1.3-3.1 nmol/l 0.300 nmol/ml Expiry date 12 weeks 8 weeks  Reference standards by
11731360 nmol/l 0.8-2.0 ng/ml 0.195 ng/ml weighing the T3 into
(18)[c] 0.195-6.51 * analyte-free human serum
ng/ml matrix
T4 5.40-320.0 66-181 nmol/l 5.40 nmol/l Expiry date 12 weeks 8 weeks  ID-GC/MS (isotope
12017709 nmol/l 5.1-14.1 g/dl 0.42 g/dl dilution gas
(18)[c] 0.420-24.86 * chromatography mass
g/dl spectrometry)
TSH 0.005-100.0 0.27-4.2 IU/ml * 0.005 IU/ml Expiry date 12 weeks 8 weeks Diluent MA WHO-reference standard
11731459 IU/ml (0.014 µIU/ml) 1:10
(18)[s] (> 10 IU/ml)
* see method sheet
 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.
Claudia Schäfer, CIR, Penzberg  4486 Jan. 2015 Reag2010.doc Page 1
Version 6.0
Assay Measuring range Reference range LDL/LoD Reagent Reagent Reagent Dilution Reference material or
Cat.no. (functional stability stability stability on (conc. of diluted Reference method /
(total duration in sensitivity/ unopened opened board sample must be) Standardisation
min.) LoQ, if 2-8C 2-8C
sandwich 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
Calcitonin 0.5-2000 pg/ml * 0.5 pg/ml Expiry date 12 weeks 8 weeks 1:100 with Dil Ma IRP WHO Reference
06445853 (1 pg/ml) (> 20 pg/ml) Standard 89/620
(18)[s
Tg II 0.04-500 ng/ml 3.5 -77 ng/ml 0.04 ng/ml Expiry date 12 weeks 4 weeks 1:10 with Dil MA CRM (Certified
06445896 * (1 ng/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 Dil. NISBC
06368590 (18)[c] Uni manually (>
200 IU/ml*
Anti-TSHR 0.3-40 IU/l * ~ 0.3 IU/l Expiry date 3 weeks* 3 weeks* Neg. human sera NISBC
04388780 1:5 or 1:10
(27)[c] # (> 4 IU/l)*
* see method sheet
 Only one set of pretreatement reagent kit can be placed on Elecsys 2010. With cobas e 411 software version 02-04 more than one set can be used.
 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. 06513107)
Version 6.0
Cat.no. (functional stability stability stability on (conc. of Reference method
(total sensitivity/ unopened opened board diluted sample /Standardisation
duration in LoQ, if 2-8C 2-8C must be)
min.) available)
[competitive/
sandwich
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 ng/ml  21 ng/ml Expiry date 12 weeks 8 weeks 1:10 Inhouse reference
11820788/ Women 25-58 ng/ml (> 50 ng/ml) preparation
12178214 *
# (9/18)[s]
proBNP II 5-35000 pg/ml * 5 pg/ml Expiry date 12 weeks 8 weeks 1:2 Elecsys® proBNP
04842464 0.6-4130 pmol/l 0.6 pmol/l (> 15000 pg/ml,
(18)[s] (< 50 pg/ml, < > 1770 pmol/l)
5.9 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 STAT
hs * ( 13 ng/l) 1:10 (this in turn was calibrated
05092728 / (> 1000 ng/l) using Enzymun-Test
05092744 Troponin T
# (9/18)[s]
* see method sheet
# 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.
Version 6.0
(total sensitivity/ unopened opened board diluted sample /Standardisation
duration in LoQ, if 2-8C 2-8C must be)
min.) available)
[competitive/
sandwich
assay]
Troponin I 0.16-25 ng/ml * 0.16 ng/ml Expiry date 4 weeks 2 weeks 1:10 with Dil. Commercially available
05094798 MA troponin I assay
# (9)[s] (> 3 ng/ml)
Digoxin 0.15-5.0 ng/ml therapheutic range 0.15 ng/ml Expiry date 12 weeks 8 weeks 1:2 By weighing United States
11820796 0.19-6.4 nmol/l 0.9-2.0 ng/ml 0.19 nmol/l (> 2.5ng/ml Pharmacopoeia (USP)
(18)[c] 1.2-2.6 nmol/l > 3.2 nmol/l) digoxin reference material
* into analyte free human
serum
Digitoxin 2.00-80.0 ng/ml therapheutic range 2.00 ng/ml Expiry date 12 weeks 4 weeks 1:2 Reference standards by
03002659 2.62-105 nmol/l 10-30 ng/ml 2.62 nmol/l (> 10 ng/ml weighing digitoxin
(18)[c] 13-39 nmol/l > 13 nmol/l)
*
HCG STAT 0.5-10000 * 0.5 mIU/ml Expiry date 12 weeks 4 weeks 1:100 NIBSC standard
03300811 mIU/ml (> 100 mIU/ml)
(9)[s]
HCG+ 0.100-10000 * 0.1 mIU/ml Expiry date 12 weeks 4 weeks 1:100 NIBSC standard
03271749 mIU/ml (< 0.6 (> 100 mIU/ml)
(18)[s] mIU/ml)
* see method sheet
Version 6.0
Assay Measuring Reference LDL/LoD Reagent Reagent Reagent Dilution Reference material or
Cat.no. range range (functional stability stability stability (conc. of diluted Reference method
(total duration sensitivity/ unopened opened on board sample must be) /Standardisation
in min.) LoQ, if available) 2-8C 2-8C
[competitive/
sandwich assay]
ACTH 1.0-2000 pg/ml * 1.0 pg/ml Expiry date 12 weeks 4 weeks  Gravimetically with synthetic
03255751 0.22-440 pmol/l 0.22 pg/ml ACTH produced at Roche 
(18) [s]
AMH 0.01-23 ng/ml * 0.01 ng/ml Expiry date 12 weeks 8 weeks 1:2 with Dil Uni 2 Beckman Coulter AMH Gen
06331076 (0.03 ng/ml) (> 10 ng/mL) II ELISA assay
(18) [s]
Cortisol 0.5-1750 nmol/l * < 0.5 nmol/l Expiry date 12 weeks 8 weeks 1:10 Enzymun-Test Cortisol (this
11875116 0.018-63.4 µg/dl (< 8.5 nmol/l) (> 50 nmol/l in turn was calibrated via ID-
(18)[c] < 0.018 µg/dl > 1.8 µg/dl) MS)
(< 0.308 µg/dl) * (for urine s.)
DHEA-S 0.003-27 µmol/l * 0.003 µmol/l Expiry date 12 weeks 8 weeks diluent: low Gravimetrically produced
03000087 0.100-1000 0.10 µg/dl concentrated master calibrators consisting
(18)[c] µg/dl human sera 1:5 of exactly defined DHEA-S
(> 1.5 µmol/l concentrations in depleted
> 45 µg/dl) human serum matrix.
*
Estradiol III 18.4-11010 * 18.4 pmol/l Expiry date 12 weeks 8 weeks diluent MA ID-GC/MS
06656021 pmol/l (91.8 pmol/l) 1:10
(18)[c] 5.00-3000 pg/ml 5.0 pg/ml (> 881 pmol/l
(25 pg/ml) > 240 pg/ml)
FSH 0.100-200.0 *  0.10 mIU/ml Expiry date 12 weeks 8 weeks  Enzymun-Test FSH (this in
11775863 mIU/ml turn was calibrated using
(18)[s] WHO-reference standard)
* see method sheet  Dilution not necessary due to the broad measuring range.
Version 6.0
Assay Measuring Reference LDL/LoD Reagent Reagent Reagent Dilution Reference material or
Cat.no. range range (functional stability stability stability (conc. of diluted Reference method
(total duration sensitivity/ unopened opened on board sample must be) /Standardisation
in min.) LoQ, if available) 2-8C 2-8C
[competitive/
sandwich assay]
LH 0.100-200 * 0.10 mIU/ml Expiry date 12 weeks 8 weeks  2nd International Standard
11732234 mIU/ml (NIBSC)
(18)[s]
Progesterone II 0.095-191 * 0.095 nmol/l Expiry date 12 weeks 8 weeks Diluent E2/Prog ID-GC/MS
12145383 nmol/l (0.48 nmol/l) 1:10
(18)[c] 0.030-60.0 0.03 ng/ml (> 6 nmol/l
ng/ml (0.15 ng/ml) > 2 ng/ml)
Prolactin II 1-10000 µIU/ml * 1 µIU/ml Expiry date 12 weeks 8 weeks 1:10 WHO-reference standard
03203093 0.047-470 ng/ml 0.047 ng/ml (> 50 µIU/ml
(18)[s] > 2.4 ng/ml)
SHBG 0.35-200 nmol/l * 0.35 nmol/l Expiry date 12 weeks 7 weeks Diluent MA 1st International Standard
03052001 1:10 (NIBSC)
(18)[s] (> 20 nmol/l) *
Testosterone II 0.087-52 nmol/l * ≤ 0.087 nmol/l Expiry date 12 weeks 8 weeks  ID-GC/MS
05200067 0.025-15 ng/ml (≤ 0.416 nmol/l)
(18)[c] ≤ 0.025 ng/ml
(≤ 0.12 ng/ml)
* see method sheet
 Dilution not necessary due to the broad measuring range.
Version 6.0
(total duration sensitivity/ unopened opened board diluted sample /Standar-
in min.) LoQ, if 2-8C 2-8C must be) disation
sandwich assay]
C-Peptide 0.003-13.3 nmol/l * 0.003 nmol/l Expiry date 12 weeks 8 weeks Diluent MA WHO International
03184897 0.01-40 ng/ml 0.01ng/ml 1:10 Reference Reagent
(18)[s] (> 4 ng/ml, > 1.3
nmol/l)
Insulin 0.20-1000 µU/ml 2.6-24.9 µU/ml 0.20 µU/ml Expiry date 12 weeks 4 weeks  WHO reference standard
12017547 1.39-6945 pmol/l 17.8-173 pmol/l 1.39 pmol/l
(18)[s] *
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 pg/ml * ≤ 10 pg/ml Expiry date 12 weeks 6 weeks * Commercially available sFlt-
05109523 1 assay
(18)[s]
* see method sheet
 Dilution not necessary due to the broad measuring range.
Version 6.0
sandwich assay]
AFP 0.500-1000 IU/ml  5.8 IU/ml 0.50 IU/ml Expiry date 12 weeks 8 weeks 1:50 WHO-reference standard
04481798 0.605-1210 ng/ml  7.0 ng/ml 0.61 ng/ml (> 20 IU/ml
(18)[s] * > 24 ng/ml)
CA 125 II 0.600-5000 U/ml < 35 U/ml 1.2 U/ml Expiry date 12 weeks 6 weeks 1:5 Enzymun-Test CA 125 II
11776223 * (2 U/mL) (> 1000 U/ml) (this in turn was calibrated
(18)[s] 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 19-9
11776193 * (> 100 U/ml)
(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 72-4
11776258 * (1.0 U/ml) (> 150 U/ml)
(18)[s]
CEA 0.200-1000 ng/ml * 0.20 ng/ml Expiry date 12 weeks 6 weeks 1:50 WHO-reference standard
11731629 (> 20 ng/ml)
(18)[s]
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 21-1
11820966 * (> 250 ng/ml)
(18)[s]
* see method sheet
# Elecsys® Universal Diluent needed for pre-dilution.
Version 6.0
sandwich assay]
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 Diluent Enzymun-Test NSE
12133113 * (0.25 ng/ml) NSE
(18)[s] 1:2
(> 50 ng/ml)
ProGRP 3.00-5000 pg/ml * <3 pg/ml Expiry date 12 weeks 42 days Diluent MA ARCHITECT ProGRP
06505961 (<7 pg/ml) 1:10
(18)[s] (> 500 pg/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 /
03175243 (< 0.02 µg/l) negative human protein
(18)[s] sera or CalSet 1
(> 1 µg/l)
* see method sheet
 Dilution not necessary due to the broad measuring range
Version 6.0
Assay Measuring range Reference range LDL Reagent Reagent Reagent Dilution Reference material or
(total duration sensitivity, if unopened opened board diluted sample /Standar-
in min.) available) 2-8C 2-8C must be) disation
[competitive/
sandwich assay]
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 available
04854098 * (20 mIU/l) (> 500 mIU/l) PAPP-A Test *
(18)[s]
* see method sheet
Version 6.0
Assay Measuring range Reference LDL / LoD or Reagent Reagent Reagent Dilution Reference material or
Cat.no. range LoQ stability stability stability on (conc. of Reference method /Standar-
(total duration in (functional unopened opened board diluted sample disation
min.) sensitivity, if 2-8C 2-8C must be)
sandwich assay]
Vitamin B12 30-2000 pg/ml 243-894 pg/ml 30 pg/ml Expiry date 12 weeks 5 weeks 1:2 Commercially available
04745736 22-1476 pmol/l 179-660 22 pmol/l (> 1000 pg/ml radiobinding B12 assay
(27)[c] 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 cat.no.
03737551 (> 40 ng/ml) 11820982*
04491785#
(18)[s]
Folate III 0.64-20 ng/ml * ≤ 0.64 ng/ml Expiry date 8 weeks 2 weeks 1:2 manually Elecsys® Folate II
04476433 1.45-45.4 nmol/l ≤ 1.45 nmol/l (> 10 ng/ml cat.no. 03253678
(27)[c] > 22.7 nmol/l)

Folate RBC 120-620 ng/mL * ≤ 120 ng/ml Expiry date 8 weeks 2 weeks 1:2 manually Elecsys® Folate III
05944295 272-1407 nmol/L ≤ 272 nmol/l with hemol. R. cat.no. 04476433
(27)[c] (> 265 ng/ml
 > 602 nmol/l)
Folate RBC * * * Expiry date 14 days - * *
Hemolyzing
Reagent
05944317
-CrossLaps/ 0.010-6.00 ng/ml * 0.01 ng/ml Expiry date 12 weeks 8 weeks  Reference standards precisely
serum 10-6000 pg/ml 10 pg/ml defined by weihghing out
11972308 (< 0.07 ng/ml synthetic peptide
(18)[s] < 70 pg/ml)
* see method sheet # 200 determinations
Version 6.0
Assay Measuring range Reference LDL / LoD Reagent Reagent Reagent Dilution Reference material or
Cat.no. range (functional stability stability stability on (conc. of Reference method /Standar-
(total duration in sensitivity/ unopened opened board diluted sample disation
min.) LoQ, if 2-8C 2-8C must be)
sandwich assay]
hGH 0.030-50.0 ng/ml * 0.030 ng/ml expiry date 84 days 56 days 1:2 with Dil. Uni IRP, NIBSC code 98/574
05390125 (0.050 ng/ml)
2
(18)[s]
(> 50 ng/ml)
N-MID 0.5-300 ng/ml * < 0.50 ng/ml Expiry date 12 weeks 8 weeks 1:5 In-house reference standards:
Osteocalcin (> 60 ng/ml) osteocalcin in analyte-free
12149133 human serum matrix
(18)[s]
PTH 1.2-5000 pg/ml 15-65 pg/ml 1.2 pg/ml Expiry date 12 weeks 8 weeks  Commercially available PTH
04892470/ 0.127-530 pmol/l 1.6-6.9 pmol/l 0.127 pmol/l 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 standard
05608546 0.583-244 pmol/l (10 pg/ml*) (> 1150 pg/ml) 95/646
(18)[s]
Total P1NP 5-1200 µg/l * 5 µg/l Expiry date 8 weeks 8 weeks 1:2 Reference standards precisely
03141071 (> 100 µg/l) defined by weighing native
(18)[s] P1NP into an analyte-free
human serum matrix
Vitamin D total 3.00-70 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
(27)[c] (5 ng/ml/ 1:2
12.5 nmol/l) (> 35 ng/ml,
> 87.5 nmol/l)
* see method sheet
 Dilution not necessary due to the broad measuring range
Version 6.0
Assay Measuring range Reference LDL / LoD Reagent Reagent Reagent Dilution Reference material or
Cat.no. range (functional stability stability stability on (conc. of Reference method
(total duration in sensitivity/ unopened opened board diluted sample /Standar-
min.) LoQ, if 2-8C 2-8C must be) disation
sandwich assay]
IgE II 0.100-2500 IU/ml * 0.10 IU/ml Expiry date 12 weeks 8 weeks 1:20 WHO-reference standard
04827031 0.240-6000 ng/ml 0.24 ng/ml (> 125 IU/ml
(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: negative Commercially available
05031656 (8 U/ml) * human serum second-generation anti-
(18)[s] pool CCP assay
1:2 to 1:5
BRAHMS PCT 0.02-100 ng/ml 0.046 ng/ml*  0.02 ng/ml Expiry date 12 weeks 4 weeks diluent: negative BRAHMS PCT LIA
05056888 ( 0.06 ng/ml) human serum
(18)[s] 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 standard
05109442 pg/ml (> 50 pg/ml)
(18)[s]
Cyclosporine 30.0-2000 ng/ml * < 30 ng/ml Expiry date 84 days 56 days 1:3 Dil Uni Reference standard
05889014 (< 50 ng/ml) manually traceable to cyclosporine
(18)[c] (> 500 ng/ml) reference material by
weight.
Tacrolimus 0.5-40 ng/ml * < 0.5 ng/ml Expiry date 84 days 56 days 1:3 Dil Uni Reference standard
05889057 (< 1.0 ng/ml) manually traceable to tacrolimus
(18)[c] (> 500 ng/ml) reference material (USP =
United States
Pharmacopeia) by weight.
* see method sheet
Version 6.0
Assay Measuring Reference range LDL Clinical Clinical Reagent Reagent Reagent Dilution Reference
Cat.no. Range sensitivity specificity stability stability stability on material or
(total unopened opened board Reference
duration in 2-8C 2-8C method /Standar-
min.) disation
[competitive/
sandwich
assay]
Anti-HAV 3.00-60 IU/l Concentrations < < 3.0 IU/l * 98.85% Expiry date 8 weeks 4 weeks, Diluent Second
04854977 20 IU/l are non- * when stored Hepatitis A International
(18)[c] reactive alternatively (> 20 Standard for
* in the fridge* IU/ml) * Anti-Hepatitis A,
NIBSC code
97/646
Anti-HAV - Cut off index < 1 * 98.3-100% 100% Expiry date 8 weeks 8 weeks possible Roche reference
IgM # are non-reactive (95% * * standard
11820591 * confidence
(18) [µ- range) *
Capture]
Anti-HBc - Cut off index > 1 < 0.8 PEI 100% 99.6% resp. Expiry date 8 weeks 8 weeks possible ”HBc-Reference
11820559 are non-reactive U/ml 99.7% * material 82 (IgG
(27)[c] * * * anti-HBc)” of the
Paul Ehrlich
Institute
Anti-HBc - Cut off approx. < 3.0 PEI- 100% 100% Expiry date 8 weeks 4 weeks possible "HBc Reference
IgM # 100 PEI U/ml, E/ml * * serum IgM 84
11820567 equival cut off (IgM anti-HBc)"
(18) [µ- index is 0.9-1.1 * of the Paul
Capture] Ehrlich Institute
* see method sheet
- no information
# Elecsys® Universal Diluent needed for pre-dilution.
Version 6.0
Assay Measuring Reference LDL Clinical Clinical Reagent Reagent Reagent Dilution Reference material
Cat.no. Range range sensitivity specificity stability stability stability on (conc. of or Reference
(total unopened opened board diluted method /Standar-
duration in 2-8C 2-8C sample disation
min.) must be)
[competitive
/
sandwich
assay]
Anti-HBe - Cut off index < 0.2 PEI * 99.9% resp. Expiry date 8 weeks 8 weeks possible ”HBe-Reference
11820613 > 1.0 are non- U/ml 100% * material 82 (IgG
(18) [c] reactive * * anti-HBe)” of the
Paul Ehrlich
Institute
HBeAg - Cut off index  0.30 U/ml * 100% Expiry date 8 weeks 8 weeks possible ”HBe-Reference
11820583 < 1.0 are non- * * Antigen 82 (HBe-
(18) (s) reactive Ag)” of the Paul
* Ehrlich Institute
Anti-HBs 2 - 1000 IU/l Concentration  2.0 IU/l 99% 99.8% Expiry date 8 weeks 4 weeks 1:100 WHO-reference
11820524 s < 10 IU/l are * * (> 10 IU/l) standard
(18)[s] non-reactive
*
* see method sheet
- no information
Version 6.0
Assay Measuring Referen-ce LDL Clinical Clinical Reagent Reagent Reagent Dilution Reference
Cat.no. Range range sensitivity specificity stability stability stability on (conc. of material or
(total duration unopened opened board diluted Reference method
in min.) 2-8C 2-8C sample /Standar-
[competitive/ must be) disation
sandwich
assay]
HBsAg II - Cut off PEI Std. ay:  0.04 99.9% IR (initial Expiry date 8 weeks 4 weeks * NIBSC standard
04687787 index < 0.9 E/ml reactive)
(18)[s] are not ad:  0.04 E/ml 99.91%
reactive WHO Std. ad:  0.1 RR (repeated
* IU/ml reactive)
99.98% *
HBsAg II 0.05-130 0.05 IU/ml - - Expiry date 8 weeks 8 weeks 1:100 with NISBC standard
quant IU/ml * Diluent
05957435 (undiluted Universal
(18)[s] samples)
* see method sheet
Version 6.0
Assay Measuring Reference range LDL Clinical Clinical Reagent Reagent Reagent stability Dilution Reference
Cat.no. Range sensitivity specificity stability stability on board (conc. of material or
(total unopened opened diluted Reference
duration in 2-8C 2-8C sample must method
min.) be) /Standar-
[competitive/ disation
sandwich
assay]
HBsAg - x > 50% = neg. or * * * Expiry date 8 weeks - * *
Confir- false-reactive
matory Test *
11820648 *
Anti-HCV II - Cut off index < * * Expiry date - 31 days, if - *
06368921 0.9 are non continuously
(18)[s] reactive stored on board.
Cut off index  or 7 weeks and up
0.9-<1.0 are to 80 hours in
consid. borderl. total on board if
Samples  1 COI stored alternately
are reactive. in fridge/system.
HIV Ag - Cut off index < * * 99.84% expiry date 4 weeks 4 weeks - NIBSC
11971611 0.9 are not (blood code 90/636
(18)[s] reactive donors)
Cut off index 0.9-
<1.0 are deemed
borderline
HIV Ag - x < 50% = neg. or * * * expiry date 4 weeks - - *
Confir- false-reactive
matory Test *
12001101 *
* see method sheet - no information
Version 6.0
Cat.no. Range sensitivity specificity stability stability stability on (conc. of material or
(total unopened opened board diluted Reference
duration in 2-8C 2-8C sample method
min.) must be) /Standar-
sandwich
assay]
HIV combi PT - Cut off index < * 100% (95% 99.88% (blood expiry date 12 weeks 4 weeks - NIBSC, code
05390095 0.9 are non- conf. limit = donors)* 90/636
(27)[s] reactive 99.76%)
Cut off index 0.9-
<1.0 are
borderline
Cut off index ≥ 1
are reactive
Syphilis - * * 100% (95% 99.88% (95% Expiry date 56 days 28 days - *
06923348 lower lower
(18)(s) confidence limit confidence
99.60%)* limit 99.77%)*
CMV IgG 0.25-500 U/ml * 0.25 U/ml - - expiry date 12 weeks 3 weeks* 1:20 with Internal Roche
04618815 Dil. Uni. standard for CMV
(18)(s) (> 15 U/ml) IgG
CMV IgG 0.25-500 U/ml * 0.25 U/ml - - expiry date 12 weeks 3 weeks* 1:20 Internal Roche
Avidity manually standard for CMV
05909708 with IgG
(18)(s) Diluent.
Universal
(> 15 U/ml)
* see method sheet
Version 6.0
sandwich
assay]
CMV IgM - Cut off index < - - - expiry date 12 weeks 2 weeks; 84 h - Roche standard
04784618 0.8 are not in case of
(18)[µ-capture) reactive alternate
Cut off index ≥ storage at 2-
0.8 - < 1.0 COI are 8°C and 20-
indeterminateCut 25°C during
off index ≥ 1 are 12 weeks
reactive
HSV-1 IgG - Non-reactive < - - - expiry date 8 weeks 28 days - Roche standard
05572185 0.6 COI
(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 standard
05572193 0.51 COI
(18)[s Gray-zone: ≥
0.51-<1.0 COI
Reactive ≥ 1.0
COI
- no information
* see method sheet
Version 6.0
sandwich
assay]
Rubella IgG 0.17-500 * 0.17 IU/ml - - expiry date 12 weeks 2 weeks, 84 h 1:20 1st International
04618793 IU/ml in case of (> 10 Standard for
(18)[s] alternate IU/ml) Anti-Rubella
storage at 2- Immun-
8°C and 20- globulin
25°C during
12 weeks
Rubella IgM - Cut off index < - * * expiry date 12 weeks 2 weeks; 84 h - Roche standard
(18)[µ- reactive alternate
capture) Cut off index ≥ storage at 2-
0.8 - < 1.0 COI 8°C and 20-
are 25°C during
indeterminateC 12 weeks
ut off index ≥ 1
are reactive
- no information
* see method sheet
Version 6.0
(total duration unopened opened board diluted Reference
in min.) 2-8C 2-8C sample method
[competitive/
must be) /Standar-
sandwich assay]
disation
rd
Toxo IgG 0.13-650 * 0.125 IU/ml - - expiry date 12 weeks 2 weeks, 84 h 1:20 3 International
04618815 IU/ml in case of (> 3 Standard for
(18)(s) alternate IU/ml) anti-
storage at 2- Toxoplasma
8°C and 20- serum (TOXM)
25°C during from NIBSC
12 weeks
Toxo IgG - * - - - expiry date 12 weeks 2 weeks, 84 h see 3rd International
Avidity in case of package Standard for
05802571 alternate insert - anti-
(18)(s) storage at 2- Dilution Toxoplasma
8°C and 20- with serum (TOXM)
25°C during DilToxoAv from NIBSC
12 weeks
Toxo IgM - Cut off index < - - - expiry date 12 weeks 2 weeks; 84 h - Roche standard
(18)[µ- reactive alternate
capture) Cut off index ≥ storage at 2-
0.8 - < 1.0 COI 8°C and 20-
are 25°C during
indeterminateC 12 weeks
ut off index ≥ 1
are reactive
* see method sheet
Version 6.0
Assay Specified intraassay precision internal evaluation measured Specified interassay precision  internal evaluation measured
intraassay precision interassay precision
FT3 III LoB - 3 pmol/l ≤ 0.15 pmol/l SD 0.045 pmol/l SD LoB - 3 pmol/l ≤ 0.25 pmol/l SD 0.125 pmol/l
> 3-50 pmol/l ≤ 5% CV 2.3, 2.0, 1.1% CV > 3-50 pmol/l ≤ 8% CV 3.6, 3.5, 1.9% CV
Including 95% confidence interval Including 95% confidence interval
FT4 II LoB - 5 pmol/l ≤ 0.25 pmol/l SD 0.072 pmol/l SD LoB - 5 pmol/l ≤ 0.4 pmol/l SD 0.14 pmol/l
> 5-100 pmol/l ≤ 5% CV 1.3, 1.7, 1.8% CV > 5-100 pmol/l ≤ 8% CV 2.1, 4.4, 3.3% CV
Including 95% confidence interval Including 95% confidence interval
T3 0.7-1.2 nmol/l 4% CV 2.8% CV 0.7-1.2 nmol/l 6% CV 5.4% CV
1.2-2.5nmol/l 3% CV 1.3, 2.1, 1.5% CV 1.2-2.5nmol/l 6% CV 4.8, 4.7% CV
2.5-10 nmol/l 3% CV 1.8% 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 3% CV 2.5, 2.0% CV 160-250 nmol/l 4%CV 3.0, 2.7% CV
TSH 0.05-0.1 U/ml 10% CV 8.6% CV 0.01-0.1 U/ml 20 % CV 8.7, 5.4% CV
0.1-4 U/ml 5% CV 2.1, 1.8, 1.9% CV 0.1-4 U/ml 7% CV 2.2, 3.3, 3.6% CV
4-20 U/ml 2% CV 1.5% CV 4-20 U/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.
Version 6.0
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 II LoD – 0.5 ng/ml SD +/- 0.04 ng/ml 0.01 ng/ml SD LoD – 0.5 ng/ml SD +/- 0.05 ng/ml 0.017 ng/ml SD
> 0.5-500 ng/ml ≤ 8% CV 2.2, 1.3, 3.0% CV > 0.5-500 ng/ml ≤ 10% CV 2.6, 4.3, 3.2% CV
Calcitonin LoD – 10 pg/ml SD  0.5 pg/ml LoD – 10 pg/ml SD  0.6 pg/ml
> 10 pg/ml ≤ 5% CV 3.4, 2.5, 2.9% CV > 10 pg/ml ≤ 6% CV 5.2, 3.5, 4.0% 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-TPO 15-40 IU/ml  10% CV 6, 8.8, 7.1% CV 15-40 IU/ml  15% CV 6.7, 11, 7.7% CV
> 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
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

Version 6.0
Assay Specified intraassay precision internal evaluation Specified interassay precision  internal evaluation interassay precision
intraassay precision
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 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
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
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+ 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

Version 6.0
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
AMH 0.01- 0.5 ng/ml ± 0.025 ng/ml 0.004 ng/ml SD 0.01- 0.5 ng/ml ± 0.03 ng/ml 0.01 ng/ml SD
0.5-1 ng/ml  5% CV 1.1% CV 0.5-1 ng/ml  6% CV 4.0% CV
1-8 ng/ml  4% CV 1.2% CV 1-8 ng/ml  5% CV 3.4% CV
> 8 ng/ml  3% CV 1.1, 1.5% CV > 8 ng/ml  5% CV 3.7, 3.8% CV
Cortisol > 110 nmol/l < 6% CV 1.4, 1, 1.3, 1.3, 1.1% CV > 110 nmol/l < 8% CV 1.6, 1.4, 1.6, 1.5, 1.6% CV
serum
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% CV 50-1000 µg/dl < 7% CV 2.6, 3.1, 3.6, 4.7, 2.4% CV
Estradiol III LoD-50 pg/ml  4 pg/ml 2.6, 2.2, 2.1 pg/ml LoD-50 pg/ml  6 pg/ml 3.6, 3.0, 3.1 pg/ml
> 50-200 pg/ml  7% CV 1.8, 3.1% CV > 50-200 pg/ml  10% CV 2.5, 3.4% CV
> 200-3000 pg/ml  6% CV 3.1, 1.9, 2.4% CV > 200-3000 pg/ml  6% CV 3.5, 2.5, 2.8% 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
 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.
Version 6.0
Assay Specified intraassay precision internal evaluation Specified interassay precision  internal evaluation measured
measured intraassay interassay precision
precision
Progesterone II > 1-5 ng/ml  5% CV 2.4% CV > 1-5 ng/ml  6% CV 5.4% CV
> 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% CV 100-5000 µIU/ml  6% CV 5, 3.6, 2.8, 3.7, 4.2, 3.4% 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 II 0.15 – 0.5 ng/ml  10% CV 2.8% CV 0.15 – 0.5 ng/ml  20% CV 3.8% CV
1-3 ng/ml  5% CV 1.9, 1.8% CV 1-3 ng/ml  6% CV 2.8, 3.7% 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
Version 6.0
Assay Specified intraassay precision internal evaluation intraassay Specified interassay precision  internal evaluation
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% CV
50-200 U/ml < 5%CV 2.7, 1.4, 1.9% 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 SD
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
Version 6.0
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
ProGRP 7-60 pg/ml  +/- 3 pg/ml SD 0.171, 0.57 pg/ml SD 7-60 pg/ml  +/- 6 pg/ml SD 0.28 pg/ml
>60-1000 pg/ml  5% CV 0.7, 0.8% CV >60-1000 pg/ml  10% CV 0.9, 1.1% CV
>1000-5000 pg/ml  5% CV 0.8, 0.9% CV >1000-5000 pg/ml  10% CV 0.9, 1.7% 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
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 ßhCG  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
> 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
Version 6.0
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
Folate RBC ≤ 155 ng/ml ≤ 11 ng/ml SD 5.2, 4.9 ng/ml SD ≤ 250 ng/ml ≤ 17.5 ng/ml SD 8.7, 12.2 ng/ml SD
> 155 ng/ml ≤ 7 % CV 4.1, 3.3% CV > 250 ng/ml ≤ 7 % CV 6.2, 4.7% CV
* Please check method sheet
na not available at the moment
Version 6.0
-CrossLaps/ 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
serum 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
> 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 deviation 0.003 ng/ml SD
deviation > 0.7 – 50 ng/ml  7% CV 0.7, 1.0% CV
> 0.7 – 50 ng/ml  6% CV 1.7, 2.6% CV
N-MID 1-10 ng/ml < 0.5 ng/ml SD 0.3 ng/ml SD 1-10 ng/ml < 0.8 ng/ml SD 0.33 ng/ml SD
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
Version 6.0
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 0.075-0.1 ng/ml  15% CV 1.3, 2.1% CV 0.075-0.1 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
Cyclosporine LoD -  90 ng/ml  +/- 7 ng/ml 2.45 ng/ml SD LoD -  90 ng/ml  +/- 9 ng/ml 5.8 ng/ml
> 90-2000 ng/ml  +/-8% CV 3.1, 3.5, 3.2% CV > 90-2000 ng/ml  +/-10% CV 7, 6, 4.7% CV
Tacrolimus 0.5-3.5 ng/ml  0.25 ng/ml SD 0.064 ng/ml SD 0.5-3.5 ng/ml  0.35 ng/ml SD 0.182 ng/ml SD
> 3.5 – 12 ng/ml  6% CV 2.5% CV > 3.5 – 12 ng/ml  6% CV 5.6% CV
>12-40 ng/ml  7% CV 2.6, 2.3% SV >12-40 ng/ml  7% CV 3.3, 2.7% CV
Version 6.0
Assay Specified intraassay precision internal evaluation intraassay Specified interassay precision  internal evaluation interassay
precision precision
Anti-HAV HS, neg < 3 IU/ml SD - HS, neg < 3 IU/ml SD HS, weakly -
HS, weakly pos < 7% CV 1.2% CV 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, weakly pos  7% CV 3.4% CV HS, weakly 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, weakly pos  7% CV 3.9% CV HS, weakly 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, weakly pos  5% CV 3.5% CV HS, weakly 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, weakly pos  3% CV 2.0% CV HS, weakly 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
Version 6.0
precision precision
HBeAg HS, neg  10% CV 4.0% CV HS, neg  10% CV 4.0, 1.7% CV
HS, weakly pos  5% CV HS, weakly 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
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 undiluted 0.13 IU/ml SD 0.05-5 IU/ml SD  0.6 IU/ml undiluted 0.17 IU/ml SD
quant. 5-130 IU/ml  10% CV undiluted 0.6% CV 5-130 IU/ml  12% CV undiluted 5.6% CV
5-13000 IU/ml  15% CV diluted 2.6% CV 5-13000 IU/ml  17% CV diluted 5.6& CV
Anti-HCV II  0.5 COI SD  0.1 COI 0.01 COI SD  0.5 COI SD  0.12 COI 0.01 COI SD
> 0.5-<1.0 COI SD  0.07 COI 0.02 COI SD > 0.5-<1.0 COI SD  0.10 COI 0.03, 0.04 COI SD
1-<18 COI  7% CV 2.6, 2.7 % CV 1-<18 COI  10% CV 4.2, 4.6 % CV
 18 % COI  8% CV 2.4 % CV  18 % COI  10% CV 5.2 % CV
HIV Ag HS, neg - 5.2% CV HS, neg - 7.1% CV
HS, weakly pos  5 % CV 2.7% CV HS, weakly 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
Version 6.0
precision precision
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.  6% CV 0.9% CV HIV Ag pos.  10% CV 1.8% CV
Syphilis 0 – 1.0 COI SD  0.07 COI 0.004 COI SD 0 – 1.0 COI SD  0.1 COI 0.003 COI SD
COI > 1.0  5.5% CV 1.3, 1.1% CV COI > 1.0  7.5% CV 3.2, 1.9% 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
Version 6.0
precision precision
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
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 IgG Low avidity samples  10 % CV 4.3, 7.3% CV n/a n/a
Avidity Greyzone samples  8 % CV 1.7% CV
High-avidity samples  8 % CV 0.6, 1% 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)
Version 6.0
Assay Calibration Calibrator Calibrator Calibrator Calibrator Calibrator Freezing Calibrator Calibrator
Cat.no. frequence target stability stability stability possible material volume per
Calibrator Cal 1/ unopened opended on board bottle/
Cal 2 2-8C 2-8C 20-25C lyophilized ready- Pipetting
to- use volume
FT3 III ° as required,  2/40 pmol/l Expiry date 8 weeks 5 hours Y - lyo. human serum 1 ml
06437222 e.g. control with added FT3 15 l
not within
range
FT4 II ° every  10/45 pmol/l Expiry date 12 weeks 5 hours Y - buffer/protein 1 ml
06437290 month/two or matrix with added 15 l
three months* L-thyroxine
T3 (same lot)  1.25/8.5 Expiry date 8 weeks 5 hours Y - lyo. human serum 1 ml
11731548 ° every week nmol/l, with added T3 30 l
(same RP)  0.8/5.5
ng/ml
T4  50/230 Expiry date 12 weeks 5 hours Y - buffer/protein 1 ml
12017717 nmol/l, matrix with added 15 l
 3.9/17.9 L-thyroxine
µg/dl
TSH  0/1.5 µIU/ml Expiry date 12 weeks 5 hours Y - equine serum 1.3 ml
04738551 matrix CalSet 1, 50 l
human serum
matrix CalSet 2
with added
recombinant TSH
- no information
* see method sheet
Version 6.0
Calibrator Cal 1/ unopened opended on board bottle/
Cal 2 2-8C 2-8C 20-25C lyophilized ready- Pipetting
to- use volume
T-uptake ° as required,  0.5/1.3 TBI Expiry date 12 weeks 5 hours Y - buffer/protein/TB 1 ml
11731505 e.g. control G matrix with 15 l
not within added L-thyrox.
range
Tg ° every  4/850 ng/ml Expiry date 3 days 5 hours Y 1x lyo. human serum 1 ml
06445900 month/two or (-20C / 3 with added tg 20 l
three months* months)
Calcitonin (same lot)  2/500 pg/ml Expiry date 3 days 5 hours Y 1x Equine serum 1 ml
06445861 ° every week (-20°C / 12 matrix with added 50 µl
(same RP) weeks) synthetic
Calcitonin
Anti-Tg  40/3250 Expiry date 6 weeks 5 hours Y not possible human serum 1.5 ml
06368603 IU/ml matrix with added 10 µl
human anti-TG
antibodies
Anti-TPO   35/350 Expiry date 6 weeks 5 hours Y not possible human serum 1.5 ml
06472931 IU/ml matrix with added 20 µl
polyclonal anti-
TPO
Anti-TSHR   1/25 IU/l expiry date - 3 hours Y 1x human serum 2 ml
(-20C / 3 matrix with added 50 µl
month) Anti-TSHR
antibodies
- no information  calibrators are part of the test kit * see method sheet
 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.
Version 6.0
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
CK-MB ° as required,  1.5/25 ng/ml Expiry date 2 weeks 5 hours Y 1x lyo. human 1 ml
05957664 e.g. control (-20C / 3 serum with 15 l
(9 min)/ not within month) added CK-MB
05957656 range
(18 min) ° every
Myoglobin month/two or  35/1200 Expiry date 12 weeks 5 hours Y - buffer/ 1 ml
11820893 three months* ng/ml protein matrix 15 µl
(9 min)/ (same lot) with added
12178222 ° every week myoglobin
(18 min) (same RP)
proBNP II  140/2700 Expiry date 2 weeks 5 hours Y 1x equine serum 1 ml
03121658 pg/ml (-20C / 3 matrix with 15 µl
 16.6/320 month) added proBNP
pmol/l
Troponin T  18/4200 ng/l Expiry date 2 weeks 5 hours Y 1x lyo. rec. 1 ml
hs (-20C / 3 human serum 50 l
05092736 month) with added
(9 min)/ Troponin T
05092752
(18 min)
- no information
* see method sheet
Version 6.0
to- use volume
Troponin I ° as required,  0.4/30 Expiry date 4 days 5 hours Y 3 months human serum 1 ml
STAT e.g. control ng/ml, (freeze only matrix with 30 µl
05094801 not within once) added TNI
range
Digoxin ° every  0.61/3.61 Expiry date 12 weeks 5 hours Y - bovine serum 1.5 ml
11820907 month/two ng/ml, matrix with 10 µl
or three  0.78/4.62 added Digoxin
months* nmol/l
Digitoxin (same lot)  5.00/60 Expiry date 12 weeks 5 hours Y - lyo. human 1 ml
03002667 ° every week ng/ml, serum with 15 µl
(same RP)  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 l
added HCG
HCG+  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
* see method sheet
Version 6.0
Calibra-tor Cal 1/Cal 2 unopened opended on board bottle/
2-8C 2-8C 20-25C lyophilized ready- Pip. Vol.
to- use
ACTH ° as required,  15/120 Expiry date - use Y 1x lyo. equine serum 1 ml
03255760 e.g. control pg/ml immediately (-20C / 3 with added 50 µl
not within and only once months) ACTH
range
AMH ° every  0.04/8 Expiry date 24 hours use only once Y 1x lyo. Equine serum 1 ml
10840633 month/two or ng/mL (-20C / 4 matrix with added 50 µl
three months*  0.28/60 weeks) AMH
(same lot) pmol/L
Cortisol ° every week  12.5/1000 Expiry date - use only once Y 1x lyo. human serum 1 ml
11875124 (same RP) nmol/l (-20C / 3 with added 20 µl
 0.45/36 months) Cortisol
µg/dl
DHEA-S  0.14/20 Expiry date - use only once Y 1x lyo. human serum 1 ml
03000095 µmol/l (-20C / 3 with added 15 µl
 5/750 µg/dl months) DHEA-S
Estradiol III  73/7340 Expiry date - use only once Y 1x lyo. human serum 1 ml
06656048 pmol/l, (-20C / 31 matrix with added 25 µl
 20/2000 days) Estradiol
pg/ml
FSH II  1/55 Expiry date - use only once Y 1x lyo. equine serum 1 ml
03032680 mIU/ml (-20C / 3 matrix with added 40 µl
months) human FSH
- no information
* see method sheet
Version 6.0
Calibrator Cal 1/Cal 2 unopened opended on board lyophilized ready- to- bottle/
2-8C 2-8C 20-25C use Pip. Vol.
LH II ° as required,  1/45 Expiry date - use only once Y 1x lyo. human 1 ml
03561097 e.g. control mIU/ml (-20C / 3 serum matrix 20 µl
not within month) with added LH
range
Progesterone II ° every  0.6/169 Expiry date 12 weeks use only once Y - lyo. human 1 ml
12145391 month/two nmol/l serum with 30 µl
or three  0.2/53 ng/ml added
months* Progesterone
(same lot)
Prolactin II ° every week  2/2000 Expiry date - use only once Y 1x lyo. buffer/prot. 1 ml
03277356 (same RP) µIU/ml, (-20C / 3 matrix with 10 µl
 0.09/94 month) added
ng/ml recombinant
Prolactin
SHBG  0/40 nmol/l Expiry date - use only once Y 1x lyo. equine 1 ml
03052028 (-20C / 2 serum (Cal1) 10 µl
month) and human
serum (Cal 2)
Testosterone II < 1.4/ 40 Expiry date - use only once Y 1x lyo. human 1 ml
05202230 nmol/l, (-20C / 3 serum with 20 µl
< 0.4/ 11.5 month) added
ng/ml Testosterone
(from plant
material)
- no information
* see method sheet
Version 6.0
2-8C 2-8C 20-25C lyophilized ready- to- Pip. Vol.
use
C-Peptide ° as required,  0.167/6.67 Expiry date - use only once Y 1x lyo. equine 1 ml
03184919 e.g. control nmol/l (-20C / 1 serum matrix 20 µl
not within  0.5/20 ng/ml month) with added C-
range peptide
Insulin ° every  5/300 µU/ml Expiry date - use only once Y 1x lyo. bovine 1 ml
12017504 month/two or  35/2080 (-20C / 3 serum with 20 µl
three months* pmol/l months) added insulin
(same lot)
PlGF ° every week  5/1200 Expiry date - 2 hours Y 1x Mutein, human, 1 ml
05144701 (same RP) pg/ml (-20C / 1 rec. from E.coli 50 µl
month)
sFlt-1  5/15000 Expiry date - 3 hours Y 1x Fragment, 1 ml
05109531 pg/ml (-20C / 1 human, rec. 20 µl
month)
- no information
* see method sheet
Version 6.0
to- use volume
AFP II ° as required,  5/50 IU/ml, Expiry date 6 weeks 5 hours Y 1x lyo. human serum 1 ml
04487761 e.g. control  6/60 ng/ml (-20C / 6 with added 10 l
not within weeks) human AFP
range
CA 125 II ° every  35/500 U/ml Expiry date 12 weeks 5 hours Y - human serum 1 ml
07030207 month/two with added 40 µl
or three human CA 125
months*
(same lot)
CA 15-3 II ° every week  15/100 U/ml Expiry date 12 weeks 5 hours Y - human serum 1 ml
03045846 (same RP) with added 20 µl
human CA 15-3
CA 19-9  20/250 U/ml Expiry date 4 weeks 5 hours Y 1x lyo. human serum 1 ml
11776215 (-20C / 2 with added 10 µl
month) human CA 19-9
CA 72-4  1/70 U/ml Expiry date 6 weeks 5 hours Y - lyo. human serum 1 ml
11776274 with added 30 µl
human CA 72-4
- no information
* see method sheet
Version 6.0
to- use volume
CEA ° as required,  5/50 ng/ml Expiry date 12 weeks 5 hours Y - buffer/protein 1 ml
11731645 e.g. control matrix with 10 l
not within added CEA
Cyfra range  0/50 ng/ml Expiry date 8 weeks 5 hours Y - lyo. human 1 ml
21-1 ° every serum with 20 µl
11820974 month/two or added
three months* cytokeratin
HE4 (same lot)  5/200 pmol/l Expiry date 7 days 5 hours Y - equine serum 1 ml
05950945 ° every week matrix with 10 µl
added HE4
NSE (same RP)  0.5/50 ng/ml Expiry date 6 weeks 3 hours Y - buffer/protein 1 ml
12133121 matrix with 20 µl
added NSE
ProGRP  20/294 Expiry date - 5 hours Y 2 months equine serum 1 ml
06505970 pg/ml (may be matrix with 30 µl
frozen twice) added
recombinant
ProGRP
free PSA  0.1/20 ng/ml Expiry date 12 weeks 5 hours Y - buffer/protein 1 ml
03289796 matrix with 20 µl
added human
PSA
total PSA II  0/60 ng/ml Expiry date 6 weeks 5 hours Y - 1x human serum 1 ml
04485220 (-20C / 3 matrix with 20 l
month) added human
PSA
- no information * see method sheet
Version 6.0
to- use volume
S100 ° as required,  0.2/2.0 µg/l Expiry date 4 weeks 5 hours Y 3 month lyo. human 1 ml
03289834 e.g. control (freeze only serum with 20 µl
not within once) added
range S100B()
antigen
Free ° every  1/64 IU/L Expiry date 6 weeks 5 hours Y 3 month lyo. human 1 ml
ß-hCG month/two or (freeze only serum with 10 µl
04854080 three months* once) added free
(same lot) ßhCG
° every week
PAPP-A (same RP)  75/2500 Expiry date - 5 hours Y 3 month lyo. hzman 1 ml
04854191 mIU/L (freeze only serum matrix 15 µl
once) added PAPP-A
- no information
* see method sheet
Version 6.0
to- use volume
Vitamin B12 ° as required,  100/1500 Expiry date 3 days use only once Y 3 months human serum 1 ml
II e.g. control pg/ml, (freeze only with added 15 µl
04572459 not within  74/1107 once) B12
range pmol/l
Ferritin ° every  10/300 ng/ml Expiry date 12 weeks 5 hours Y - human serum 1 ml
037375868 month/two with added 10 µl
or three Ferritin
months*
(same lot)
° every week
Folate III# (same RP)  4/17 ng/ml Expiry date 3 days use only once Y 3 months lyo. human 1 ml
04874072  9.1/38.5 (freeze only serum 25 µl
nmol/l once) albumin
matrix with
added Folate
Folate RBC# - Expiry date 3 days use only once Y 3 months lyo. human 1 ml
05944309 (freeze only serum with 25 µl
once) added Folate
- no information
# reconstitution time 30 minutes
* see method sheet
Version 6.0
to- use volume
-CrossLaps/ ° as required,  0.05/2.0 Expiry date 12 weeks 5 hours Y - -CTx 1 ml
serum e.g. control ng/ml (synthetic 50 µl
11972316 not within  50/2000 peptide) in an
range pg/ml equine matrix
N-MID ° every  0/280 ng/ml Expiry date 1 week 5 hours Y 1x human serum 1 ml
Osteocalcin month/two or (-20C / 3 with added 20 µl
11972111 three months* month) Osteocalcin
(same lot) (synthetic
° every week peptide, human
sequence)
hGH (same RP)  0/10 ng/ml Expiry date 7 days 5 hours Y 1x (-20°C / hGH 1 ml
05390133  0/10000 28 days) recombinant 40 µl
pg/ml peptide in
human serum
matrix
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
- no information
* see method sheet
Version 6.0
to- use volume
PTH (1-84) ° as required,  0.1/420 Expiry date 5 days 5 hours Y 1x PTH (synthetic 1 ml
05608554 e.g. control pg/ml (-20C / 90 peptide, human 50 µl
not within  0.01/42 days) sequence) in
range pmol/l human serum
° every matrix
Total P1NP month/two or  25/850 µg/l expiry date 1 week up to 24 hours Y 5x P1NP (human) 1 ml
03141080 three months* (-20°C / 3 in human serum 20 µl
(same lot) month matrix
° every week
Vitamin D (same RP)  2/45 ng/ml expiry date 120 hours up to 5 hours Y 1x 25-OH Vitamin 1 ml
total  5/113 nmol/l (-20C / 28 D3 in human 15 µl
05894921 daysh) serum matrix
- no information
* see method sheet
Version 6.0
to- use volume
IgE ° as required,  1/100 IU/ml Expiry date 12 weeks 5 hours Y - equine serum 1 ml
11930427 e.g. control  2.4/240 ng/ml matrix with 10 µl
not within added human
range IgE
° every
Anti-CCP month/two or  20 / 200 U/ml Expiry date - 2 hours Y 4 weeks Anti-CCP 1 ml
three (freeze only antibodies in 15 µl
months* once) human serum
(same lot) matrix
° every week
BRAHMS (same RP)  0.1 / 54 ng/ml Expiry date - 2 hours Y 3 months PCT in human 1 ml
PCT (freeze only serum matrix 30 µl
once)
IL-6  18 / 700 pf/ml Expiry date - 5 hours Y 3 months IL-6 (human, 2 ml
05109469 (freeze only rec.) 30 µl
once)
Cyclosporine  30/1600 ng/ml Expiry date 7 days 5 hours Y 28 days Cyclosporine 1 ml
05889022 (freeze only in human 20 µl
once) blood matrix
Tacrolimus  1/30 ng/ml Expiry date 7 days 5 hours Y 28 days Tacrolimus in 1 ml
05889065 (freeze only human blood 35 µl
once) matrix
- no information
* see method sheet
Version 6.0
-
FOR ALL INFECTIOUS DISEASE ASSAYS: CALIBRATORS ARE PART OF THE TEST KIT; LOT NUMBER OF RACKPACK AND CALIBRATORS ARE IDENTICAL
Assay Calibration Calibrator Calibrator Calibrator Calibrator Calibrator Freezing Calibrator material Calibrator
Calibrator frequence target range stability stability stability possible volume per
are within the Qual.: counts unopened opended on board bottle/
testkit Quant.: units 2-8C 2-8C 20-25C lyophilized ready- Pipetting
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 46 IU/l in human
month/two or serum
Anti-HAV three months* na Expiry date 8 weeks 5 hours Y - Cal1: neg. calibrator, 0.67 ml
IgM (same lot) human serum 10 µl
° every week Cal2: pos.
(same RP) 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 l
Cal2: 100- Cal2: pos.
3000 calibrator,Anti-HBc
(human) > 8 PEI
units/ml in human
serum
- no information
* see method sheet
Version 6.0
are within the Qual.: counts unopened opended on board bottle/
testkit Quant.: units 2-8C 2-8C 20-25C lyophilized ready- Pipetting
to- use volume
Anti-HBc ° as required, Cal1: 600- Expiry date 8 weeks 5 hours Y - Cal1: neg. calibrator, 1 ml
IgM e.g. control 3500 human serum 10 µl
not w(same Cal2: 24000- Cal2: pos.
RP)ithin 150000 calibrator,Anti-HBc
range (human) > 100 PEI
° every 1 U/ml in human serum
month (same
lot)
° every week
(same RP)
- no information
* see method sheet
Version 6.0
are within Qual.: counts unopened opended on board bottle/
the testkit Quant.: units 2-8C 2-8C 20-25C lyophilized ready- Pipetting
to- use volume
Anti-HBe ° as required, Cal1: 300000- Expiry date 8 weeks 5 hours Y - Cal1: neg. calibr., 1 ml
e.g. control 1500000 human serum 35µl
not within Cal2: 1000- Cal2: pos.
range 6000 calibrator,Anti-HBe
° every (human) > 3 PEI
month/two or U/ml in human
three months* serum
HBeAg (same lot) Cal1: 400- Expiry date 8 weeks 5 hours Y - Cal1: neg. calibrator, 1 ml
° every week 2000 human serum 35 µl
(same RP) Cal2: 20000- Cal2: pos.
100000 calibratorHBeAg
(E.coli, rDNA)
approx. 5 U/ml [PEI
units] in He.
Anti-HBs Cal1: 4-15 IU/l Expiry date 8 weeks 5 hours Y - Cal1: Anti-HBs 1.3 ml
Cal2: 350-600 (human) in human 40 µl
IU/l serum
Cal2: Anti-HBs
(human) in human
serum
- no information
* see method sheet
Version 6.0
Calibrator frequence target range stability stability stability possible material volume per
to- use volume
HBsAg II ° as required, Cal1: 600- Expiry date 8 weeks 5 hours Y - Cal1: neg. 1.3 ml
e.g. control 1700 calibrator, human 50µl
not within Cal2: 3000- serum
range 11000 Cal2: pos.
° every calibrator, HBsAg
month/two or 0.5 IU/ml in human
three months* serum
HBsAg II (same lot)  0 / 0.5 IU/ml Expiry date 8 weeks 5 hours Y - Cal1: neg. 1.3 ml
quant calibrator, human 50µl
° every week
serum
(same RP) Cal2: pos.
calibrator, HBsAg
0.5 IU/ml in human
serum
Anti-HCV Cal1: 400- Expiry date 8 weeks 5 hours Y - Cal1: neg. cal. , 1.3 ml
II 3000 human serum 50 µl
Cal2: 25000- Cal2: pos.
350000 calibrator, human
serum positive for
anti HCV Ab
- no information
* see method sheet
Version 6.0
to- use volume
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 p24-
° every antigen (E.coli,
month/two or rDNA) 240 pg/ml
three months* in acetate buffer
HIV combi (same lot) Cal1:1200- Expiry date 12 weeks 5 hours Y Do not Cal1: neg. cal., 1 ml
PT ° every week 5000 freeze human serum 40 µl
(same RP) Cal2: 17000- Cal2: pos.
75000 calibrator, human
serum Anti-HIV-1
positive
Syphilis Cal1: 450- Expiry date 28 days 6 hours Y 6 months Cal1: neg. cal. 1 ml
4000 stable at - Human serum 10 µl
Cal2: 22000- 20°C (3 Cal2: pos. cal.
140000 freeze/thaw Human serum
cycles reactive for anti-
possible) syphilis antibodies
- no information
* see method sheet
Version 6.0
FOR ALL TORCH ASSAYS: CALIBRATORS ARE PART OF THE TEST KIT; LOT NUMBER OF RACKPACK AND CALIBRATORS ARE IDENTICAL
to- use volume
CMV IgG ° as required, Cal1: neg. expiry date 8 weeks 5 hours Y - Cal1: neg. 1 ml
e.g. control Cal2: ~ 40 calibrator, human 20 µl
not within U/ml serum (hs)
range Cal2: pos.
° every calibrator, hs
CMV IgG month/two or Cal1: neg. expiry date 8 weeks 5 hours Y - Cal1: neg. 1 ml
Avidity three months* Cal2: ~ 40 calibrator, human 20 µl
(same lot) U/ml serum (hs)
° every week Cal2: pos.
(same RP) calibrator, hs
CMV IgM Cal1: 500- expiry date 4 weeks 5 hours Y - Cal1: neg. 1 ml
1600 calibrator, hs 10 µl
Cal2: 2800- Cal2: pos.
16000 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.
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.
- no information
* see method sheet
Version 6.0
FOR ALL TORCH ASSAYS: CALIBRATORS ARE PART OF THE TEST KIT; LOT NUMBER OF RACKPACK AND CALIBRATORS ARE IDENTICAL
to- use volume
Rubella IgG ° as required, Cal1: neg. expiry date 8 weeks 5 hours Y - Cal1: neg. 1 ml
e.g. control Cal2: ~ 400 calibrator, human 10 µl
not within IU/ml serum (hs)
range Cal2: pos. Cal., hs
° every
Rubella IgM month/two or Cal1: neg. expiry date 4 weeks 5 hours Y - Cal1: neg. cal., hs 1 ml
three months* Cal2: ~ 700 Cal2: pos. cal., hs 10 µl
(same lot) U/ml
° every week
(same RP)
Toxo IgG Cal1: neg. expiry date 8 weeks 5 hours Y - Cal1: neg. cal., hs 1 ml
Cal2: ~ 100 Cal2: pos. cal., hs 10 µl
IU/ml
Toxo IgG Cal1: neg. expiry date 8 weeks 5 hours Y - Cal1: neg. cal., hs 1 ml
Avidity Cal2: ~ 100 Cal2: pos. cal., hs 10 µl
IU/ml
Toxo IgM Cal1: neg. expiry date 4 weeks 5 hours Y - Cal1: neg. cal., hs 0.67 ml
Cal2: ~ 130 Cal2: pos. cal., hs 10 l
U/ml
- no information
* see method sheet
Version 6.0
Control ready-to- lyo- Package Concen- Volume Stability Stability Stability freezend Stability Control
Cat.no. use philized content tration per bottle unopened opened or 20-25C/ material
range 2-8C reconstituted on board
2-8C
PreciControl Y 2 levels, * 3 ml Expiry date 3 days one month (only -/ human
Universal each level freeze once) 5 hours# serum
11731416 two bottles matrix
PreciControl Y 2 levels, * 2 ml Expiry date 3 days three month (only -/ human
Cardiac II each level freeze once) 3 hours serum
04917049 two bottles after thawing use matrix
only once
PreciControl TN Y 2 levels, * 2 ml Expiry date 4 days three month (freeze -/ rec human
05095107 each level only once) 5 hours serum
two bottles after thawing use matrix
only once
PreciControl Y 1 level, four  0.2 µIU/ml 2 ml Expiry date 12 weeks - -/ equine
TSH bottles 5 hours serum
11776479 matrix
- no information
* see method sheet
# 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)
Version 6.0
Control ready-to- lyo- Package Concen- Volume Stability Stability Stability Stability Control
Cat.no. use philized content tration per bottle unopened opened or freezend 20-25C/ material
range 2-8C reconstituted on board
2-8C
PreciControl Y 2 levels, * 3 ml Expiry date 2 weeks one month 24 hours/ human serum
Tumormarker each level (only freeze 5 hours matrix
11776452 two bottles once)
PreciControl Y 2 levels,  40/650 1 ml Expiry date 14 days 28 days Up to 5 human serm
ProGRP$ each level pg/ml (only freeze hours/5 matrix
two bottles once) hours
PreciControl Y 2 levels, * 3 ml Expiry date 72 hours 31 days 5 hours/ human serum
Varia each level (only freeze 5 hours matrix
05618860 two bottles once)
- no information
* see method sheet
$ controls not barcoded
Version 6.0
Control ready-to- lyo- Package Concen- Volu-me Stability Stability Stability Stability Control
Cat.no. use philized content tration per unopened opened or freezend 20-25C/ material
range bottle 2-8C reconsti-tuted on board
2-8C
PreciControl Y 2 levels, * 2 ml Expiry date 72 hours 31 days (freeze -/ equine
Multimarker each level only once) up to 5 serum
05341787 three bottles hours matrix
PreciControl Y 2 levels, * 2 ml Expiry date - three months 3 hours / 3 human
ThyroAB each level (only freeze hours serum
05042666 one bottle once) matrix
PreciControl Y 3 levels, each * 2 ml Expiry date - three months up to 5 human
Maternal Care level 2 (only freeze hours /- serum
04899881 bottles once) matrix
- no information
* see method sheet
Version 6.0
Control ready-to- lyo- Package Concen- Volume Stability Stability Stability Stability Control
Cat.no. use philized content tration per unopened opened or freezend 20-25C/ material
range bottle 2-8C reconstituted on board
2-8C
PreciControl Y 2 levels,  1/5 ng/mL 2 ml Expiry date na 28 days (freeze Use only equine
AMH$ each level  7/35 only once) once serum
06709966 two bottles pmol/L matrix
PreciControl Y 2 levels,  50/400 1 ml Expiry date 14 days 4 weeks 24 hours / 5 human
HE4 each level pmol/l (freeze only hours serum
05950953 two bottles once) matrix
PreciControl Y 2 levels,  30/100 2 ml Expiry date - one month 5 hours / 5 human
Anti-CCP$ each level U/ml (freeze only hours serum
05031664 two bottles once) matrix
BRAHMS Y 2 levels,  0.5 / 10 4 ml Expiry date - three months -/ human
PCT# each level ng/ml (only freeze 2 hours serum
two bottles once) matrix
PreciControl Y 3 levels, each * 3 ml Expiry date 7 days 28 days 5 days / - human
ISD level 1 bottle (freeze only blood
05889081 once)
* See method sheet
# Calibrators and Controls are part of the test kit.
$ controls not barcoded
Version 6.0
Control ready-to- Package Nominal range for Volume Stability Stability Stability Control material
Cat.no. use content cutoff index (qual.) per bottle unopened opened on board
Concentration 2-8 oC 2-8 oC
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 two IU/l PC 1:  20 IU/l
04855043 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 IgM each level PC2: approx. 3 hours PC 2: Anti-HAV IgM antibodies
11876368 eight bottles U/ml (human)  3 U/ml (PEI 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 (human)
11876325 eight bottles  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 (human)
11876384 eight bottles  0.25 U/ml (PEI units) in
human serum
Version 6.0
range (quant.)
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
HBsAg II each level PC2: 2.6-5.0 PC 2: HBsAg (human)  0.2 IU/ml in
04687876 eight bottles human serum
PreciControl Y 2 levels PC1: 0-0.3 1.3 ml Expiry date 8 weeks 5 hours PC 1: human serum
Anti-HCV each level PC2: ~ 8 PC 2: Anti-HCV in human serum
03290379 eight bottles
PreciControl Y 3 levels * 2 ml Expiry date 8 weeks up to 5 PC 1: hs, negative for HIV
HIV each level hours PC 2: hs, positive for anti-HIV
05162645 two bottles antibodies
PC 3: cirate buffer, pH 4.0, approx.
400 pg/ml HIV p24-Ag
PreciControl Y 2 levels PC1: ~ 0.15 COI 2 ml Expiry date 28 days up to 5 PC 1: human serum negative
Syphilis each level PC2: ~ 5 COI hours PC 2: Syphilis-IgG antibody positive
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
* see method sheet
Version 6.0
range (quant.)
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 four PC 2: positive PC 2: human serum positive
04784626 bottles
PreciControl Lyo 2 levels PC 1: negative 3 ml expiry date 14 days 5 hours PC 1: human serum negative
HSV each level two PC 2: positive PC 2: human serum positive
05572207 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 four PC 2: ~550 U/ml PC 2: human serum positive
04618840 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: low avidity 1 ml expiry date 8 weeks 5 hours PC 1: human serum
Toxo IgG each level PC 2: high avidity PC 2: human serum
Avidity three bottles
05802580
Version 6.0
range (quant.)
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
Version 6.0
Diluent Package Volume per Stability unopened Stability opened 2-8°C Stability on board Contents
Cat.no. content bottle 2-8C
Diluent Universal 2 bottles 16 ml Expiry date - 3 months protein matrix, preservative
11732277  0.1%
03183971 connected  0.1%
05192943 connected  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 blood
Estradiol/Progesterone donors
03028542
- no information
Version 6.0
System reagent Package Volume Stability Stability Stability Stability on Stability on Contents
Cat.no. content per bottle unopened unopened 2- opened board opened board
15-25C 8°C 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 solution
(SysClean Adapter protected from < 2% Cl act.
11933159) light)
- no information
Version 6.0
System Accessories Description Package content

Cat.no.
AssayTips Disposable tips for pipetting samples and reagent 30 x 120 tips
11706799
Assay Cups Reaction tubes for performing Elecsys® 60 x 60 cups
11706802 Immunoassays
CleanLiner Resealable plastic waste bags for the Elecsys® 2010 1 * 14 bags
11800507 container
CalSet Vials Empty snap-cap vials for reconstituted calibrator 2 x 56 bottles
11776586 for direct use on Elecsys® 2010 Systems
Control Vials Empty snap-cap vials for reconstituted controls for 2 x 56 bottles
03142949 direct use on Elecsys® 2010 Systems
Version 6.0
Used Documents:
Assay Method sheet Application report

FT3 III 1212/01 2_3_AR02_SummaryReport_fT3 III
FT4 II 1212/01 2_3_AR02_SummaryReport_fT4 II
T3 0811/20 2_t3020a.xls/2_t3050a.xls (NCCLS precision)
T4 1011/16 2_t4050a.xls (NCCLS precision)
TSH 0911/20 2tsh050a.xls (NCCLS precision)
T-uptake 0911/09 2tbk050a.xls (NCCLS precision)
Calcitonin 1113/03 2_3_AR01_SummaryReport_Calcitonin
Tg II 1013/01 2_3_AR01_SummaryReport_Tg II
Anti-Tg 0710/02 2atg050a.xls (NCCLS precision)
Anti-TPO 0811/02 2tpo050c.xls (NCCLS precision)
Anti-TSHR 0911/09 2atr050a.xls (NCCLS precision)
CK-MB STAT 0812/03 2_3AR01_Application Report Summary_CK-MB.doc
Myoglobin STAT 0812/17 2myo050a.xls (NCCLS precision)
proBNP II 0512/07 2bn2050a.xls (NCCLS precision)
Troponin I STAT 0712/04 2_050a_EP5Precision_TNIstat.xls (CLSI precision)
Troponin T STAT hs 0512/07 2TS9050a.xls (CLSI precision)
Digoxin 0512/18 2dig050a.xls (NCCLS precision)
Digitoxin 0612/11 2dit050a.xls (NCCLS precision)
HCG STAT 0412/15 2HC2050c.xls (NCCLS precision)
HCG+ 0412/15 2hb2050a.xls (NCCLS precision)
ACTH 0810/05 2acth050a.xls (NCCLS precision)
AMH 0714/01 2_3_Ara_SummaryReport_AMH_7.1.2b_LP
Cortisol 0512/18 2cor050a.xls (NCCLS precision)
2cou020b.xls/2cou030b.xls (urine)
2cos020a.xls/2cos030a.xls (saliva)
DHEA-S 0912/16 2dhe050a.xls (NCCLS precision)
Estradiol III 1114/01 E2_3_Arc_Summaryreport
FSH 0412/18 2fsh050b.xls (NCCLS precision)
LH 0412/18 2_lh050a.xls (NCCLS precision)
Progesterone II 0712/15 2pg2050b.xls (NCCLS precision)
Version 6.0

Prolactin II 0312/05 2pro050a.xls (NCCLS precision)
SHBG 0512/10 2shg050a.xls (NCCLS precision)
Testosterone II 0512/06 2_050a_EP5Precision_TestoII.xls (CLSI precision)
C-Peptide 0412/08 2cpe050a.xls (NCCLS precision)
Insulin 0412/13 2in1050a.xls (NCCLS precision)
PlGF 0512/05 2PLGF050a.xls (CLSI precision)
sFlt-1 0512/05 2SFL050b.xls (CLSI precision)
AFP 0911/10 2af2050a.xls (NCCLS precision)
CA 125 II 1014/01 2125050a.xls (NCCLS precision)
CA 15-3 II 0512/16 2215050a.xls (NCCLS precision)
CA 19-9 0911/20 2192050a.xla (NCCLS precision)
CA 72-4 0312/10 2724050a.xls (NCCLS precision)
CEA 0512/20 2ce2050c.xls (NCCLS precision)
Cyfra 21-1 0812/15 2cyf050a.xls (NCCLS precision)
HE4 0612/05 2_AR01_SummaryReprot_HE4.doc
NSE 0812/11 2nse050b.xls (NCCLS precision)
ProGRP 0913/01 2_3_AR02_SummaryReport_progrp
free PSA 0211/10 2pf050b.xls (NCCLS precision)
total PSA 0510/07 2ps2050c.xls (NCCLS precision)
S100 0510/07 2sc_050a.xls (NCCLS precision)
Free hCG 0812/06 2PAP050a.xls (NCCLS precision)
PAPP-A 0411/03 2fHC050a.xls (NCCLS precision)
Vitamin B12 0112/10 2b22050a.xs (NCCLS precision)
Ferritin 0312/12 2f2g050b.xls (NCCLS precision)
Folate III 0712/10 2Fo3050a.xls (NCCLS precision)
Folate RBC 1011/01 2_3_Ara_Summary Report_FolRBC.doc
-CrossLaps/serum 1211/12 2ßCL050b.xls (NCCLS precision)
hGH 0211/02 2_3_Ara_SummaryReport_hGH.doc
N-MID Osteocalcin 1211/14 2oc050c.xls (NCCLS precision)
PTH STAT 1211/09 2PTH050a.xls (NCCLS precision)
PTH (1-84) 1012/02 2_3_ARb_SummaryReport_PTH 1-84.doc
total P1NP 0508/06 2P1_050a.xls (NCCLS precision)
Version 6.0

Vitamin D total 0812/04 2_3_AR01_SummaryReport_VitDtotal.doc
IgE II 0312/06 2ig2050b.xls (NCCLS precision)
Anti-CCP 0611/04 2acc050c.xls (NCCLS precision)
BRAHMS PCT 0712/07 2PCT050c.xls (NCCLS precision)
IL-6 0512/05 2_050b_EP5_IL-6.xls (CLSI precision)
Cyclosporine 1113/02 2_3_AR01_SummaryReport_CSA.doc
Tacrolimus 1013/02 2_3_AR01_SummaryReport_TCL.doc
Anti-HAV 0712/09 Precision from PEI report
Anti-HAV IgM 1012/12 Precision from PEI report
Anti-HBc 0610/20 Precision from PEI report
Anti-HBc IgM 0212/14 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 1112/11 Precision from PEI report
HBsAg II quant 0111/02 HBsAgII-quant-application-report-summary.doc
HBsAg Conf. Test 0812/22 Not available
Anti-HCV II 1211/02 Precision from internal evaluation report
HIV Ag 0712/11 Precision from PEI report
HIV Ag Conf. Test 1108/09 na
HIV combi PT 1212/03 Precision from internal evaluation report
Syphilis 0114/01 2_3_Ara_SummaryReport_Syphilis
CMV IgG 1012/06 2CMG050a.xls (NCCLS precision)
CMV IgG Avidity 0712/03 2_3_ARf_SummaryReport_CMV IgG Avidity.doc
CMV IgM 0712/05 2CMM050a.xls (NCCLS precision)
HSV-1 IgG 1211/02 2_050a_EP5Precision_HSV1IgG.xls
HSV-2 IgG 1211/02 2_050a_EP5Precision_HSV2IgG.xls
Rubella IgG 1012/06 Precision from internal evaluation report
Version 6.0

Rubella IgM 1012/07 Precision from internal evaluation report
Toxo IgG 0612/10 Precision from internal evaluation report
Toxo IgG Avidity 0712/03 2_3_Ara_SummaryReport_ToxoIgG Avidity
Toxo IgM 1211/07 Precision from internal evaluation report
Version 6.0
Used Documents:
CalSet Method sheet
FT3 III 1112/01
FT4 II 1112/01
T3 0610/11
T4 0610/11
Tg II 1013/01
TSH 0811/06
T-uptake 0610/13
Calcitonin 1113/01
Anti-Tg 0311/02
Anti-TPO 0910/01
CK-MB STAT 0511/01
Myoglobin STAT 0810/13
proBNP II 0610/03
Troponin T hs STAT 0610/03
Troponin I STAT 0810/02
Digoxin 1012/11
Digitoxin 0310/09
HCG STAT 0610/08
HCG+ 0610/08
ACTH 1110/04
AMH 0714/01
Cortisol 1110/10
DHEA-S 0310/08
Estradiol III 1114/01
FSH II 1110/09
LH II 0310/08
Progesterone II 0310/12
Prolactin II 1110/04
SHBG 1110/06
Testosterone II 0512/04
Version 6.0
Used Documents:
CalSet Method sheet
C-Peptide 0310/04
Insulin 0310/08
PlGF 1008/01
sFlt-1 1008/01
AFP II 0610/05
CA 125 II 1014/01
CA 15-3 II 0611/09
CA 19-9 0511/15
CA 72-4 0811/10
CEA 0610/12
Cyfra 21-1 0310/08
HE4 1112/04
NSE 0310/06
ProGRP 0913/01
free PSA 1111/09
total PSA II 0610/06
S100 0810/06
Free ßHCG 1110/04
PAPP-A 0907/01
Vitamin B12 II 0707/03
Ferritin 0610/06
Folate III 0708/01
-CrossLaps/serum 0811/09
hGH 1011/01
N-MID Osteocalcin 0610/10
PTH STAT 0610/04
PTH (1-84) 0511/01
Total P1NP 1110/06
Vitamin D total 0211/01
IgE 0610/11
IL-6 1110/02
Version 6.0
Used Documents:
CalSet Method sheet
Cyclosporine 0913/01
Tacrolimus 0913/01
Used Documents:
Controls Method sheet
PreciControl Universal 1010/05
PreciControl Cardiac II 0412/07
PreciControl Troponin 0610/03
PreciControl TSH 0710/11
PreciControl Tumormarker 0510/15
PreciControl Varia 0311/01
PreciControl ThyroAB 0710/03
PreciControl Maternal Care 0510/02
PreiControl Multimarker 0810/01
PreciControl AMH 0714/01
PreciControl HE4 0712/04
PreciControl ProGRP 0813/02
PreciControl Anti-CCP 1008/02
PreciControl ISDs 0913/01
PreciControl Anti-HAV 0410/05
PreciControl Anti-HAV IgM 0810/12
PreciControl Anti-HBc 0412/16
PreciControl Anti-HBc IgM 0610/10
PreciControl Anti-HBe 0712/12
PreciControl HBeAg 0612/10
PreciControl Anti-HBs 0612/15
PreciControl HBsAg II 0910/06
Version 6.0
Controls Method sheet
PreciControl Anti-HCV 0412/06
PreciControl HIV 0412/03
PreciControl Syphilis 0814/14
PreiControl CMV IgG 1108/01
PreciControl CMV IgG Avidity 0612/02
PreciControl CMV IgM 0908/01
PreciControl HSV 1110/01
PreciControl Rubella IgG 0811/03
PreciControl Rubella IgM 0710/05
PreciControl Toxo IgG 1011/04
PreciControl Toxo IgG Avidity 0312/02
PreciControl Toxo IgM 0710/05
”System” Reagents Method sheet

Diluent Universal 2*16 ml 0410/15
Diluent Universal 2*36 ml 0310/07
Diluent Universal 2, 2*36 ml 0714/01
Diluent MultiAssay 2* 16 ml 0310/06
Diluent NSE 0310/07
Diluent Hepatitis A 0907/06
Diluent Estradiol/Progesterone 0410/07
ProCell 0410/13
CleanCell 0410/17
SysWash Productinfo 0510
SysClean/SysClean adapter 0708/01
For this document are the contents of the current Elecsys reagent kit, CalSet, PreciControl and System reagent method sheets and Application Reports used. The
used method sheet versions and Application Reports are listed above. Original datas are available in the corresponding method sheets and Application Reports.
Version 6.0
Version 6.0

estabilidades y cv e411

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Elecsys 2010 / cobas e 411 Assays / CalSets / Controls

Claudia Schäfer, CIR, Penzberg  4486 Jan. 2015 Reag2010.doc Page 1

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* see method sheet

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 The system to system precision is defined as interassay precision x 1.5 e.g.

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 The system to system precision is defined as interassay precision x 1.5 e.g.

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 The system to system precision is defined as interassay precision x 1.5 e.g.

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Anti-HBe HS, neg  5% CV 2.4% CV HS, neg  10% CV 2.6% CV

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