Testosterone Saliva LUM Bulk

The Testosterone Saliva Luminescence Immunoassay

is intended for the quantitative measurement of testosterone in saliva in adults. Measurement of testosterone has been shown to be useful in the evaluation of hormone imbalance that results in various clinical conditions like hypogonadism (androgen deficiency) in men and hypergonadism (excess of androgen hormones) e.g. polycystic ovaries in women. Use of non-invasive sample types from saliva make the test suitable for frequent sampling and testing of testosterone levels.

The Testosterone Saliva Luminescence Immunoassay is based on the competition principle and measured on a microtiter plate luminescence reader. The assay is semi-automated requiring general purpose laboratory instruments and consumables such as luminescence microplate reader/washer, vortexer and pipettes to execute the test. Test results may be calculated manually from a standard curve and compared to laboratory established reference ranges from healthy adults (i.e. normal ranges).

The test kit is intended for professional laboratory use by trained personnel. The test kit is not for home or lay person use. The device is not intended for point-of-care settings.

Testosterone is a C19-steroid and plays an important role in the human body. It is also considered a pleiotropic hormone [1], meaning it affects different phenotypes and plays an important role in the human body. In men testosterone is produced by the testes as well minimally by the adrenal cortex. While in women the testosterone level is secreted from the adrenal cortex (25%) and the ovarian stroma (25%), the remaining testosterone production occurs in peripheral tissues such as bone, breast, muscle and fat [2]. In healthy individuals the testosterone level follows a diurnal rhythm with a peak in the morning hours and low levels throughout the day [3]. Roughly 2% of free testosterone are present in the plasma of healthy individuals with 38% albumin-bound testosterone, and 60% sex hormone-binding globulin (SHBG)-bound testosterone, while the non–protein-bound steroid hormone fraction is biologically active [4; 5]. The free testosterone is released by the salivary glands, which is clinically relevant [6]

The concentration of testosterone in saliva reflects the level of free testosterone in serum [7].

As mentioned above testosterone is no exception within steroid hormones as concentrations follow a diurnal rhythm [8], thus, sampling time and number of samples is crucial in a clinical setting to reliable evaluate the peak and baseline level of testosterone individually. It is recommended to take samples in the morning and multiple samples should be taken to confidently interpretate the testosterone level.

Measurement in men is used to diagnose clinical hypogonadism, while in women it is applied as an aid to diagnoses hyperandrogenic states e.g., hirsutism (excessive hair), ovarian failure [9] or virilization (masculinization) [10].