Description

INTENDED USE
The Calbiotech FSH ELISA Kit is intended for the quantitative measurement of FSH in human serum.

Summary and explanation
Follicle-Stimulating Hormone (FSH) is a glygoprotein produced by the anterior pituitary gland. Like other glycoproteins, such as LH, TSH, and HCG, FSH consists of subunits designated as alpha and beta. Hormones of this type have alpha subunits that are very similar structurally, therefore the biological and immunological properties of each are dependent on the unique beta subunit. In the female, FSH stimulates follicular growth, prepares ovarian follicles for action by LH and enhances the LH induced release of estrogen. FSH levels are elevated after menopause, castration and in premature ovarian failure. Although there are significant exceptions ovarian failure is indicated when random FSH concentrations exceed 40 mIU/ml. In the male, FSH stimulates seminiferous tubule and testicular growth and is involved in the early stages of spermatogenesis. Oligospermic males usually have elevated FSH levels. Tumors of the testes generally depress serum FSH concentrations, but levels of LH are elevated. High levels of FSH in men may be found in primary testicular failure and Klinefelter syndrome. Elevated concentrations are also present in cases of starvation, renal failure, hyperthyroidism, and cirrhosis.

PRINCIPLE OF THE TEST
The FSH is a solid phase direct sandwich ELISA method. The samples and diluted anti-FSH-HRP conjugate are added to the wells coated with Mab to FSH beta subunit. FSH in the patient’s serum binds to anti-FSH MAb on the well and the anti-FSH-HRP second antibody then binds to FSH. Unbound protein and HRP conjugate are washed off by wash buffer. Upon the addition of the substrate, the intensity of color is proportional to the concentration of FSH in the samples. A standard curve is prepared relating color intensity to the concentration of the FSH.