Testosterone Saliva Luminescence Immunoassay

Luminescence immunoassay for the in-vitro-diagnostic quantitative determination of testosterone in human saliva and serum. Measurement of testosterone 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. 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 cells a great part of the hormone is transformed to 5a-Dihydrotestosterone. Nevertheless, the concentration of testosterone in saliva reflects the level of free testosterone in plasma. Testosterone levels in females should be measured in patients having clinical symptoms of virilism caused by the adrenogenital syndrome, the polycystic ovary syndrome or neoplasms of the adrenal cortex or the ovaries. Due to the fluctuations, repeated measurements are recommended. A therapy with androgen suppressive drugs can be followed up by taking controls. In men with signs of primary or secondary hypogonadism, confirmatory testosterone levels can be determined. Testosterone together with cortisol levels in stress research and sports medicine represents a useful parameter. Due to the many factors that may influence the testosterone levels, it is in some situations advisable to take a profile. Therefore measuring the free testosterone in saliva is a convenient method, due to the easier sample collection without repeated venipunctures.