hCG ELISA Kit (Human Chorionic Gonadotropin)

INTENDED USE

hCG ELISA kit is a reliable quantitative procedure for measuring human chorionic gonadotropin (hCG) in serum and plasma. This assay has a minimum sensitivity detection limit of < 5.0 mIU/ml.

BACKGROUND

Human chorionic gonadotropin (hCG) is a 38.4 kD glycoprotein hormone, that is secreted by the placenta during pregnancy. Structurally it is composed of two subunits, alpha and beta, where the alpha subunit is identical to that found in FSH, TSH and LH glycoprotein hormones and the beta subunit is the specific portion and this in known to differ from one hormone to another. The difference in the beta subunit accounts for the immunochemical distinctiveness and the biological specificity of each hormone.

This high concentration of hCG is then maintained throughout pregnancy. After delivery, the concentration falls rapidly and returns to undetectable levels a few days later after. In non-pregnant women or men an increased level indicates neoplasia. Determining concentrations can be helpful in monitoring and recognising chorionic tumors or malignancies (such as; pancreatic, testicular and bronchogenic pulmonary cancers).

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 which are coated with monoclonal anti beta-hCG antibody.
• Standards 1-5: Concentration 5, 50, 200, 500, 1000 mIU/ml. The standards are calibrated against the following reference material: 5th WHO international standard NIBSC code: 07/364. Conversion: 1 pg/mL = 0.00916 mIU/mL.
• Sample Diluent.
• Enzyme Conjugate: Consisting of monoclonal 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.

SENSITIVITY

The minimum sensitivity detection limit of human chorionic gonadotropin (hCG) using current hCG ELISA kit was approximately 5.0 mIU/ml. The dynamic range for this assay is 5.0 – 1,000.0 mIU/ml.

ASSAY CHARACTERISTICS

– Assay Dynamic Range: 5 – 1000 mIU/mL.
– Sensitivity: < 5 mIU/mL
– Intra-Assay Variability: 2.2 – 4.7%
– Inter-Assay Variability: 3.3 – 4.3%
– Recovery: 93 – 106%
– Linearity: 86 – 106%
– Drug Interferences: None
– High-Dose-Hook Effect: None detected up to 13,300 mIU/mL levels of hCG.
– Interfering Substances: None

REFERENCES

1. Immunoassay of human chorionic-gonadotropin, its free subunits, and metabolites. Clin Chem. (1997) 43 (12): 2233-43. Cole LA.
2. Standardization of Epitopes for Human Chorionic Gonadotropin (hCG) Immunoassays. Curr Med Chem. (2016) 23 (30): 3481-3494. Review. Berger P. and Lapthorn A.J.
3. Serum levels of steroid and placental protein hormones in ectopic pregnancy. Eur J Obstet Gynecol Reprod Biol. (1991) 39 (2): 117-22. Mantzavinos T., et al.
4. Automated determination of human choriogonadotropin by use of microparticle capture analysis. Clin Chem. (1990) 36 (3): 554-6. Trundle D.S., et al.

ADDITIONAL INFORMATION

• Full Name: hCG ELISA Kit (Human Chorionic Gonadotropin)
• Reactivity: Human
• Sample Type: Serum
• Sensitivity: 5.0 mIU/ml

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