Elecsys® HCG+b
Electrochemiluminescence immunoassay (ECLIA)
for the in vitro quantitative determination of the
sum of human chorionic gonadotropin (hCG)
plus the b-hCG in serum and plasma
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
Elevated values of hCG during pregnancy are indicative of chorionic carcinoma, hydatiform mole, or multiple pregnancy.
HCG+b measurements can also be used in conjunction with other parameters during the second trimester of pregnancy to
assess the risk of trisomy 21 (Down syndrome).1,2,4 In contrast, decreased levels of hCG indicates threatening or missed abortion, ectopic pregnancy, gestosis, or intra-uterine death.1–3 In non-pregnant women or men, elevated hCG+b concentrations
can be used to assist diagnosis of tumors of the germ cells, ovaries, testes, bladder, pancreas, stomach, lungs, and liver.2,5,6
Test principle: sandwich immunoassay
Streptavidin-coated
microparticle
Biotinylated monoclonal
antibody against human β−hCG
Free β−hCG
in the sample
holo-hCG
in the sample
9 min
Measurement
Ru
Ru
Ru
Ru
Ru
Ruthenylated
monoclonal
antibody against
human β−hCG
9 min
Ru
1st Incubation (9 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..
2nd Incubation (9 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+β within the sample is calculated using a
calibration curve.
Elecsys® HCG+b test characteristics
Testing time
Test principle
Calibration
Sample material
18 minutes
Sandwich immunoassay
2 point
Serum, Li-, Na-, NH4+-heparin, Na2-EDTA, K3-EDTA, sodium
citrate, and sodium fluoride/potassium oxalate plasma
Low sample volume
Lower detection limit
Functional sensitivity
Measuring range
Traceability
10 μL
<0.100 mIU/mL
<0.6 mlU/mL
0.100 – 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: 2.6 – 4.6 %
(4.81 – 7,949 mIU/mL)
MODULAR ANALYTICS E170, cobas e 601 module,
cobas e 602 module: 3.3 – 7.4 % (4.73 – 8,082 mIU/mL)
Expected values in
healthy individuals
N
97.5 % of values
Upper 95 % confidence
limit
Non-pregnant
premenopausal women
181
≤1 mIU/mL
5.3 mIU/mL
Postmenopausal women
Men
143
290
≤7 mIU/mL
<2 mIU/mL
8.3 mIU/mL
2.6 mIU/mL
100 tests
4 x 1 mL
2 x 3 mL each
2 x 3 mL each
2 x 16 mL
03271749
03302652
11776452
11731416
11732277
2 x 36 mL
03183971 122
Order information
Elecsys® HCG+b
HCG+b CalSet
PreciControl Tumor Marker 1 and 2
PreciControl Universal 1 and 2
Diluent Universal
or
Diluent Universal
190
190
122
190
122
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.
4 Schlebusch, H. (1998). Prenatal screening for Down’s syndrome. In: Thomas, L. ed. Clinical laboratory diagnosis, 1st English edition. Frankfurt, TH-Books, 1124 – 1125.
5 Sturgeon, C.M., McAllister, E.J. (1998). Analysis of hCG: clinical applications and assay requirements. Ann Clin Biochem 35, 460 – 491.
6 Marcillac, I., Troalen, F., Bidart, J.M., Ghillani, P., Ribrag, V., Escudier, B., Malassagne, B., Droz, J.P., Lhommé, C., Rougier, P., Duvillard, P., Prade, M., Lugagne, P.M.,
Richard, F., Poynard, T., Bohuon, C., Wands, J., Bellet, D. (1992). Free human chorionic gonadotropin b subunit in gonadal and nongonadal neoplasms.
Cancer Res 52, 3901 – 3907.
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and LIFE NEEDS ANSWERS are trademarks of Roche.
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