Elecsys HCG STAT (Elecsys 2010, cobas e 411 analyzer ... · PDF fileElecsys® HCG STAT...
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1 st Incubation (4.5 minutes): 10 μL of the sample is incubated with both a biotinylated, monoclonal hCG- specific antibody and a ruthenylated, monoclonal hCG-specific antibody to form a sandwich complex. 2 nd 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 mea- sured by a photomultiplier and the concentration of HCG within the sample is calculated using a calibration curve. Measurement 4.5 min 4.5 min Ru Ru Ru Free β-hCG in the sample holo-hCG in the sample Biotinylated monoclonal antibody against hCG (epitope only present in holo-hCG) Streptavidin-coated microparticle Ruthenylated monoclonal antibody against human β-hCG Ru 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
Transcript of Elecsys HCG STAT (Elecsys 2010, cobas e 411 analyzer ... · PDF fileElecsys® HCG STAT...
1st Incubation (4.5 minutes):10 μL of the sample is incubated with both a biotinylated, monoclonal hCG-specific antibody and a ruthenylated, monoclonal hCG-specific antibody to form a sandwich complex.
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 mea-sured by a photomultiplier and the concentration of HCG within the sample is calculated using a calibration curve.
Measurement4.5 min 4.5 min
RuRu
Ru
Free β−hCGin the sample
holo-hCGin the sample
Biotinylated monoclonal antibody against hCG (epitope only present in holo-hCG)
Streptavidin-coatedmicroparticle
Ruthenylated monoclonal antibody againsthuman β−hCG
Ru
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)IndicationHCG 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
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Elecsys® HCG STAT test characteristicsTesting time 9 minutesTest principle Sandwich immunoassayCalibration 2 pointSample material Serum, Li-, Na-, NH4+-heparin, K3-EDTA, sodium citrate, and
sodium fluoride/potassium oxalate plasmaSample volume 10 μLLower detection limit 0.500 mIU/mLMeasuring range 0.500 – 10,000 mIU/mLTraceability 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
Order informationElecsys® HCG STAT 100 tests 03300811 190HCG STAT CalSet 4 x 1 mL 03303071 190PreciControl Universal 1 and 2 2 x 3 mL each 11731416 190Diluent Universalor Diluent Universal
2 x 16 mL
2 x 36 mL
11732277 122
03183971 122
References1 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.
