Assay Measures Low Levels of Testosterone

A chemiluminescent, microparticle immunoassay has been developed for the quantitative determination of testosterone in human serum and plasma.

In 2010, the Endocrine Society published a consensus statement calling for improved testosterone assays and noted that the availability of highly accurate testosterone assays would result "in improved diagnosis, treatment, and prevention of disease."

With a simple blood test, the ARCHITECT 2nd Generation Testosterone Assay accurately measures the wide range of testosterone levels observed in a number of different patient populations and clinical settings. The assay, which has improved sensitivity and clinical utility, is a product of Abbott (Abbott Park, IL, USA) and it has received the CE marking.

The new assay runs on Abbott’s fully automated ARCHITECT family of analyzers and is available in several European countries, Asia Pacific, Latin America, Japan, Africa, the Middle East, and India, pending country registration.

Measurements of testosterone are used in the diagnosis and treatment of disorders involving male sex hormones (androgens) including primary and secondary hypogonadism, delayed or precocious puberty, and impotence in males; and in females, hirsutism (excessive hair), and virilization (masculization) due to tumors, polycystic ovaries, and androgenital syndromes.

Many currently available testosterone assays are not sensitive enough to measure low levels of testosterone. This limits the clinical utility of these assays and can result in suboptimal patient care.

"Abbott’s ARCHITECT 2nd Generation Testosterone Assay allows for consistent and accurate testing of testosterone levels across a wide range of concentrations," said Brian Blaser, executive vice president, Diagnostics Products, Abbott. "We are extremely pleased to offer a new and important tool to address the need for a rapid, sensitive, and fully automated testosterone assay. Health care providers can now confidently measure testosterone levels and use this information to improve treatment decisions for their patients."

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