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  • Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sample (typically serum) to determine free testosterone (typically less than 3% of total testosterone), including both free testosterone and free dihydrotestosterone (DHT). Sometimes these assays include the determination of the active testosterone (i.e., bioavailable testosterone), including both the free testosterone and testosterone weakly bound to albumin, but not the fraction tightly bound to sex hormone binding globulin. Testosterone is a sex steroid vital for human reproduction; lack or low levels of free testosterone during fetal, prepubertal, and postpubertal life affect the normal male reproductive function, producing diseases such as male infertility and growth of glandular breast tissue (gynecomastia) in male adults.
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