New test measures testosterone at low levels

Abbott Laboratories has announced FDA clearance of a new testosterone test designed to accurately measure a wide range of testosterone levels seen in both men and women.

The ARCHITECT 2nd Generation Testosterone Assay “is more sensitive, accurate and precise than previous versions of the assay," said Frank Quinn, PhD, of Abbott. "The improved assay performance means physicians will be able to obtain more reliable measurements of testosterone and use this information to help guide patient treatment decisions."

The new assay runs on Abbott’s fully automated ARCHITECT family of analyzers. It is a chemiluminescent microparticle immunoassay for the quantitative determination of testosterone in human serum and plasma.

In male patients, measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones, including primary and secondary hypogonadism, delayed or precocious puberty, and erectile dysfunction.