Single Step ELISA Simplifies Free Testosterone Testing

The Free Testosterone Assay from Gold Standard Diagnostics (GSD) is a single-step, direct ELISA that could save clinical laboratories time and money, and reduce the possibility of errors.

Total Testosterone measures levels of all forms in the blood stream, including: unbound (free), loosely bound to albumin and tightly bound to sex-hormone binding globulin (SHBG). Many common factors influence SHBG levels. As a result, a Total Testosterone assessment may yield a normal result, but due to higher or lower levels of Testosterone-SHBG bonding, the concentration of Free Testosterone may not correlate directly with Total Testosterone readings.

SHBG levels can be increased by factors such as obesity and testosterone treatment. Factors that can decrease SHBG levels include aging, pregnancy and estrogen therapy. Symptoms of low testosterone in males include decreased sexual function, erectile dysfunction, loss of hair, decreased muscle mass and osteoporosis. For females, symptoms include hot flashes, irritability, decreased libido and insomnia.

Compared to indirect, multi-step testing algorithms, GSD’s FDA Cleared Free Testosterone products save laboratories time and money while reducing the possibility of errors. The combination of Free and Total Testosterone gives healthcare professionals more information to make the correct diagnosis when a Testosterone-related condition is suspected. Gold Standard Diagnostics also offers an ELISA test for Total Testosterone level to complement the Free Testosterone assay.

Testosterone testing can be fully automated with the ThunderBolt^®, which through a host of patent-pending features, delivers exceptional power and flexibility in a small size. The dual function analyzer provides complete, walk-away automation of 192 patient samples in only a 2’ by 2’ space. Completely open architecture allows any EIA or CLIA protocol to be programmed, and up to eight different protocols to run in a single batch. Intuitive and robust software further enriches the ThunderBolt^®, making it the total laboratory automation solution.

GSD’s Free and Total Testosterone assays are fully validated as ThunderBolt-Ready, ensuring quick, easy and effective implementation for any laboratory environment.