Beta hCG ELISA Kit (Beta Human Chorionic Gonadotropin)

INTENDED USE

Beta hCG ELISA kit is a reliable quantitative procedure for measuring beta human chorionic gonadotropin (beta hCG, beta-hCG) in serum samples. This assay has minimum sensitivity detection limit of 1.0 mIU/ml.

BACKGROUND

Beta human chorionic gonadotropin (beta-hCG, beta hCG) is essentially a pregnancy hormone that is produced by the cells of the implanting embryo. It can be found to be detected in the maternal plasma or urine 8-9 following ovulation, then the levels are rapidly increased until it reaches a peak level by around 8-10 weeks, after this its levels start to decline gradually for the remainder of the pregnancy.

Beta hCG has a molecular weight of 36,000 Da and is made up of 2 non-covalently bound subunits. The alpha subunit which approx. 10,205 Da molecular weight (“naked”) and is 92- amino acids in length, is identical in structure to thyroid-stimulating hormone (TSH), luteinizing hormone (LH) and follicle-stimulating hormone (FSH). The alpha subunit functions as the receptor transactivation portion. The different beta subunits are different for each of the above hormones, these display less homology and are responsible for conveying the receptor-specificity for each of the dimeric hormones. The differences in the beta subunit with each of the respective hormones is accountable for their biological specificity and immunochemical distinctiveness.

A large number of monoclonal antibodies which can recognise unique sites that are present on the beta chain of the ß-hCG/hCG molecule are essential used to differentiate between hCG and FSH, LH and TSH. There are many different assay’s that can be instrumental in the early detection during pregnancy.

CONTENT

All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.

• Microtiter Wells: Coated with anti-β-HCG antibody (monoclonal).
• Standard (0-5): Concentration 0, 5, 25, 50, 100, 200 mIU/mL. The standards are calibrated against the following reference material: 5th WHO International Standard Chorionic
• Gonadotrophin, NIBSC code: 07/364.
• Sample Diluent.
• Enzyme Conjugate.
• Substrate Solution: Tetramethylbenzidine (TMB).
• Stop Solution.

SENSITIVITY

The minimum sensitivity detection limit of beta hCG (human beta chorionic gonadotropin or beta-hCG) using current beta hCG ELISA kit was approximately 1.0 mIU/ml. The dynamic range for this assay is 5.0 – 200.0 mIU/ml.

ASSAY CHARACTERISTICS

– Assay Dynamic Range: 0 – 200 mIU/mL.
– Analytical Sensitivity: < 1 mIU/mL.
– Intra Assay Variation: 3.40 – 8.90%
– Inter Assay Variation: 6.6 – 9.9%
– Recovery: 89 – 100%
– Linearity: 90 – 110%
– Drug Interference: None
– High Dose Hook Effect: None observed up to 158,600 mIU/mL of β-HCG.
– Interfering Substances: Haemoglobin (up to 4 mg/mL), Bilirubin (up to 0.5 mg/mL) and Triglyceride (up to 30 mg/mL) have no influence on the assay results.

REFERENCES

1. Immunoassay of human chorionic gonadotropin, its free subunits, and metabolites. Clin Chem. (1997) 43 (12): 2233-43. Review. Cole L.A.
2. High level of beta-hCG simulating pregnancy in recurrent osteosarcoma: case report and review of literature. J Cancer Res Clin Oncol. (2004) 130 (6): 357-61. Review. Leidinger B., et al.
3. Alpha-fetoprotein and beta-human chorionic gonadotropin: their clinical significance as tumour markers. Drugs. (1999) 57 (4): 463-7. Review. Gregory J.J. Jr and Finlay J.L.
4. The hCG assay or pregnancy test. Clin Chem Lab Med. (2012) 50 (4): 617-30. Review. Cole L.A.

ADDITIONAL INFORMATION

• Full Name: Beta hCG ELISA Kit (Beta Human Chorionic Gonadotropin)
• Reactivity: Human
• Sample Type: Serum
• Sensitivity: 1.0 mIU/ml

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