Diagnostic Kit for Follicle-Stimulating Hormone
(fluorescence immunochromatographic assay)
For in vitro diagnostic use onlyDiagnostic Kit for Follicle-Stimulating Hormone (fluorescence immunochromatographic assay) is a fluorescence Immunochromatographic assay for the quantitative detection of Follicle-Stimulating Hormone (FSH) in human serum or plasma, which is mainly used to evaluate the endocrine function of pituitary gland. All positive sample must be confirmed by other methodologies. This test is intended for healthcare professional use only.
SUMMARY
Follicle-Stimulating Hormone is a kind of glycoprotein hormone secreted by basophil and the molecular mass of 30kD.FSH is
controlled by hypothalamic gonadotropin releasing hormone, and its function is to promote the development of follicle.The male promotes the formation and spermatogenesis of the vasculum.According to the middle period of the menstrual cycle, FSH and LH reached the peak value at the same time, and FSH increased to predict ovulation. Detection of follicle-stimulating hormone concentration for amenorrhoea, primary low sex gland function, secondary low sex gland function, precocious puberty, polycystic ovary syndrome, climacteric syndrome, the diagnosis of pituitary adenomas has important clinical significance . The Diagnostic Kit is based on immunochromatography and can give a result within 15 minutes.
PRINCIPLE OF THE PROCEDURE
The membrane of the test device is coated with anti FSH antibody on the test region and goat anti rabbit IgG antibody on the control region. Lable pad are coated by fluorescence labeled anti FSH antibody and rabbit IgG in advance. When testing positive sample, the FSH antigen in sample combine with fluorescence labeled anti FSH antibody, and form immune mixture. Under the action of the immunochromatography, the complex flow in the direction of absorbent paper, when complex passed the test region, it combined with anti FSH coating antibody, forms new complex. FSH level is positively correlated with fluorescence signal, and the concentration of FSH in sample can be detected by fluorescence immunoassay assay.