RE62031-RE62039IFUenTestosteroneLUMV2010-09：re62031-re62039ifuEN睾酮LUMv2010-09.pdfVIP

Instructions for Use Testosterone Luminescence Immunoassay Luminescence immunoassay for the in-vitro-diagnostic quantitative determination of testosterone in human saliva and serum. RE62031 / RE62039 96 960 2-8°C I B L I N T E R N A T I O N A L G M B H Flughafenstrasse 52a Phone: +49 (0)40-53 28 91-0 IBL@IBL-I D-22335 Hamburg, Germany Fax: +49 (0)40-53 28 91-11 www.IBL-I Testosterone Luminescence Immunoassay (RE62031 / RE62039) ENGLISH 1. INTENDED USE Luminescence Immunoassay for the quantitative determination of free testosterone in saliva and of total testosterone in diluted serum. Measurement of testosterone (a male sex hormone) is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in males and in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries and adrenogenital syndromes. 2. SUMMARY AND EXPLANATION Testosterone, a C19-Steroid, is the most effective natural hormone in the family of androgens. In males, it is mainly produced in the Leydig cells of the testes, only a small amount is produced in the adrenal cortex. On the whole, adult males have 10 to 20 fold higher testosterone plasma concentrations than females. In the circulation, the main part of testosterone is bound to plasma proteins like sex hormone binding globuline (SHBG) and albumine. Only 1 – 2 % of the testosterone is unbound and therefore biologically active. The free testosterone is released via the salivary glands. In their cel