Free Beta hCG ELISA Kit (Beta Human Chorionic Gonadotropin)
INTENDED USE
Human free beta hCG ELISA kit is a reliable quantitative procedure for measuring free beta subunit of human chorionic gonadotropin (free beta hCG, free beta-hCG) in serum. This assay has minimum sensitivity detection limit of 0.25 ng/ml.
BACKGROUND
Free beta chorionic gonadotropin (free beta hCG) is a glycoprotein hormone that is produced by the placenta during pregnancy. Structurally intact hCG molecules are made up of two polypeptide subunits which are non-covalently linked together – alpha and beta chain subunits. The measurement of alpha subunit is known to give similar results whereas measuring the beta subunits doesn’t. Therefore monoclonal antibodies which are able to recognise unique sites on the beta chain of the ß-hCG/hCG molecule play an essential role in differentiating between hCG and FSH, LH and TSH hormones.
The development of specific assay makes it possible for early detection during pregnancy and this has been vital in screening for Down syndrome and trisomy 18. There are also evidence that high levels of ß-hCG/hCG may be associated with chorionepithelioma, seminoma, embryonal cell carcinoma, neoplasms of trophoblastic and nontrophoblastic origin (eg. hydatiform mole).
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.
- Microtiterwell Plate: Break apart strips that have been coated with monoclonal anti-beta hCG antibody.
- Standard 0-5: Concentration 0, 10, 25, 50, 100, 200.0 ng/ml; standards match the WHO reference reagent (NIBSC code: 99/650).
- Control Low and Control High.
- Zero Buffer.
- Enzyme Conjugate: Consisting of antibody conjugated to horseradish peroxidase.
- Substrate Solution: Tetramethylbenzidine (TMB).
- Stop Solution: Contains 0.5 M H2SO4, Avoid contact with the stop solution. It may cause skin irritations and burns.
- Wash Solution (40x Concentrated).
SENSITIVITY
The minimum sensitivity detection limit of free beta subunit chorionic gonadotropin (beta hCG, beta-hCG) using current free beta hCG ELISA kit was approximately 0.25 ng/ml. The dynamic range for this assay is 0.25 – 50.0 ng/ml.
ASSAY CHARACTERISTICS
– Assay Dynamic Range: 0.2 – 200 ng/ml
– Specificity (Cross Reactivity): Produced Color Intensity Equivalent to free β-HCG in Serum.
TSH (25 µIU/mL) < 0.3 ng/mL, FSH (100 mIU/mL) < 0.2 ng/mL, Prolactin (100 mIU/mL) < 0.5 ng/mL, LH (200 mIU/mL) < 1 ng/mL.
– Analytical Sensitivity: 0.2 ng/ml
– Intra-Assay Variability: 5.83 – 6.78%
– Inter-Assay Variability: 6.73 – 8.03%
– Recovery: 86.2 – 109.4%
– Linearity: 92.9 – 113.0%
– Interfering Substances: None
– High-Dose-Hook Effect: None detected up to 1980000 ng/mL levels of free beta hCG.
– Drug Interferences: None
REFERENCES
- The biological and clinical significance of nicks in human chorionic gonadotropin and its free-beta-subunit. Yale J Biol Med. (1991) 64 (6): 627-37. Review. Cole L.A., et al.
- Physiological studies of human chorionic gonadotropin (hCG), αhCG, and βhCG as measured by specific monoclonal immunoradiometric assays. Endocrinology (1987) 120: 549-558. Ozturk, M., et al.
- The stability of blood samples for the measurement of the free β subunit of chorionic gonadotrophin. Prenat. Diagn. (1995) 15: 94-95. Densem J., and Wald N.J.
- The beta-core fragment of human chorionic gonadotropin: biochemical background and clinical application. Anticancer Res. (1997) 17 (2B): 1255-72. Review. Schutter E.M., et al.
ADDITIONAL INFORMATION
- Full Name: Free Beta hCG ELISA Kit (Beta Human Chorionic Gonadotropin)
- Reactivity: Human
- Sample Type: Serum
- Sensitivity: 0.25 ng/ml
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