Beta-hCG (human Chorionic Gonadotropin) ELISA for serum or plasma 1-400 mIU/ml Dialab

Human Chorionic Gonadotropin (hCG) is a glycoprotein hormone secreted in pregnancy, that is made by the embryo soon after conception and later by the syncytiotrophoblast (part of the placenta). Its role is to prevent the disintegration of the corpus luteum of the ovary and thereby maintain progesterone production that is critical for a pregnancy in humans. hCG may have additional functions, for instance it is thought that it affects the immune tolerance of the pregnancy.

Pregnancy tests measure the levels of the hCG in the blood or urine to indicate the presence or absence of an implanted embryo. In particular, pregnancy tests employ an antibody that is specific to the β subunit of hCG (β-hCG). This is important so that tests do not make false positives by confusing hCG with LH and FSH.

β-hCG is also secreted by some cancers including teratomas, choriocarcinomas. But elevated levels cannot prove the presences of a tumour, and low levels do not rule it out.

Normal levels: <8.0 mIU/mL
Pregnancy: 1 Week: 3.0-100 mIU/mL
2 Weeks: 10-1000 mIU/mL
3 Weeks: 100-10,000 mIU/mL
4 Weeks: 1000-100,000 mIU/mL
2 Months: 15,000-200,000 mIU/mL
3 Months: 10,000-100,000 mIU/mL

This assay is intended for the quantitative determination of β-hCG in human serum or plasma for diagnostic use. This 96 well ELISA can provide up to 40 patient tests. hCG in the sample is simultaneously captured by a monoclonal antibody immobilised on the microplate which is directed against the of β-hCG fraction and a second monoclonal antibody conjugated with horseradish peroxidase (HRP) that is directed to the α-hCG subunit. After incubation, the bound/free separation is performed by a simple solid-phase washing step. Then the enzyme HRP in the bound reaction reacts with the substrate to develop a blue colour which changes to yellow on addition of the stop solution. The colour intensity, as determined by reading absorbance at 450nm, is proportional to the concentration of β-hCG in the sample.

Kit contents:
Antibody coated Microtiter wells (Anti- β-hCG): 12x8 well strips

Calibrator set (0, 1, 5, 20, 100, 400 mIU/mL): 6x1ml

Control: 1x1ml

Enzyme Conjugate (Anti-α-hCG-HRP): 1x1ml

Conjugate Diluent: 1x50ml phosphate buffer 50mM, pH 7.4, BSA 1g/L

Substrate Solution (H₂O₂-TMB 0.26g/L): 1x15ml

Stop Solution (Sulphuric Acid 0.15mol/L): 1x15ml

Wash Buffer 50X: 1x20ml NaCl, 45g/L; Tween 20 55g/L

Once open reagents can be kept at 2-8°C for up to 6 months. Diluted wash buffer is stable for 30 days at 2-8°C.

Sample volume: 25µl human serum or plasma to be run in duplicate

Incubation time: 75 minutes (60 min at room temperature, 15 min in the dark at room temperature)

Measurable range: 1-400 mIU/mL

Sensitivity: 0.09 mIU/mL

Specificity: h β-hCG 100.00%, hFSH 3.0%. hCG 4.0%, hTSH 0.02%

Store at 2-8°C.