Elecsys HCG STAT (Elecsys 2010, cobas e 411 analyzer)

Elecsys® HCG STAT (Elecsys® 2010,
cobas e 411 analyzer)
Electrochemiluminescence immunoassay (ECLIA)
for the in vitro quantitative determination of human
chorionic gonadotropin (hCG) in serum and plasma
(short turnaround time)
Indication
HCG is produced in the placenta during pregnancy and its role is to maintain the corpus luteum. It also influences steroid
production. HCG exists as a number of isohormones and the serum of pregnant women contains mainly intact hCG.1–3
Measurement of hCG levels is used clinically to diagnose pregnancy as early as one week after conception. In addition,
elevated hCG concentrations during the first trimester are indicative of chorionic carcinoma, hydatidiform mole, or multiple
pregnancy, whereas decreased levels are associated with threatening or missed abortion, ectopic pregnancy, gestosis, or
intra-uterine death.1–3
Test principle: sandwich immunoassay
Biotinylated monoclonal
antibody against hCG
(epitope only present
in holo-hCG)
Streptavidin-coated
microparticle
Free β−hCG
in the sample
4.5 min
Measurement
Ru
Ru
1st Incubation (4.5 minutes):
10 μL of the sample is incubated with
both a biotinylated, monoclonal hCGspecific antibody and a ruthenylated,
monoclonal hCG-specific antibody to
form a sandwich complex.
Ru
Ruthenylated
monoclonal
antibody against
human β−hCG
Ru
4.5 min
holo-hCG
in the sample
2nd Incubation (4.5 minutes):
Streptavidin-coated microparticles are
added to the reaction mixture and the
complex binds to the solid phase via
biotin–streptavidin interactions.
Measurement:
The reaction mixture is transferred to a measuring cell and
the microparticles are magnetically captured onto the
surface of an electrode; unbound sample is washed away
before a chemiluminescent reaction is induced by applying
a voltage to the electrode. Chemiluminescence is measured by a photomultiplier and the concentration of HCG
within the sample is calculated using a calibration curve.
Elecsys® HCG STAT test characteristics
Testing time
Test principle
Calibration
Sample material
Sample volume
Lower detection limit
Measuring range
Traceability
9 minutes
Sandwich immunoassay
2 point
Serum, Li-, Na-, NH4+-heparin, K3-EDTA, sodium citrate, and
sodium fluoride/potassium oxalate plasma
10 μL
0.500 mIU/mL
0.500 – 10,000 mIU/mL
Standardized against the 4th International Standard for
Chorionic Gonadotropin from the National Institute for
Biological Standards and Control (NIBSC) 75/589
Intermediate precision (CLSI)
Elecsys® 2010 analyzer, cobas e 411 analyzer: 1.9 – 3.1 %
(10.6 – 4,634 mIU/mL)
Expected values
N
97.5th percentile
Upper 95 % confidence
limit
Non-pregnant
premenopausal women
182
≤1 mIU/mL
4.9 mIU/mL
Postmenopausal women
143
≤7 mIU/mL
8.1 mIU/mL
100 tests
4 x 1 mL
2 x 3 mL each
2 x 16 mL
03300811 190
03303071 190
11731416 190
11732277 122
2 x 36 mL
03183971 122
Order information
Elecsys® HCG STAT
HCG STAT CalSet
PreciControl Universal 1 and 2
Diluent Universal
or
Diluent Universal
References
1 Cole, L.A. (1997). Immunoassay of human chorionic gonadotropin, its free subunits, and metabolites. Clin Chem 43, 2233 – 2243.
2 Cole, L.A. (2009). New discoveries on the biology and detection of human chorionic gonadotropin. Reprod Biol Endocrinol 7, 8 – 44.
3 Cole, L.A., (2010). Biological functions of hCG and hCG-related molecules. Reprod Biol Endocrinol 8, 102 – 115.
COBAS, COBAS E, ELECSYS and
LIFE NEEDS ANSWERS are trademarks of Roche.
Not for distribution in the USA.
©2012 Roche
Roche Diagnostics International Ltd.
CH-6343 Rotkreuz
Switzerland
www.cobas.com