Testosterone II Assay Improved for Female Samples

A new, improved testosterone II assay is more accurate for female samples.

The new automated testosterone assay reduces cross reactivity to dehydroepiandrosterone sulphate (DHEAS) and susceptibility to matrix effect with female samples. It ensures reliable results, helping clinicians to improve diagnoses of andrenogenital syndrome, polycystic ovary (Stein-Leventhal syndrome), ovarian tumor, adrenal tumor, adrenal hyperplasia, or ovarian insufficiency.

A Roche (Burgess Hill, UK) product, the Elecsys testosterone II assay delivers enhanced accuracy against the gold standard ID-gas chromatograph/mass spectrography (GC/MS) methods for female samples in the range of 0.025-1.5 ng/mL. The improved performance of the assay is due to a new high affinity testosterone monoclonal antibody. The antibody enables optimized recovery of testosterone and ensures excellent precision, especially at low concentration levels.

The short turnaround time of the Elecsys testosterone II assay (18 minutes) and small sample volume required (20 µl) improves workflow and allows complete endocrinology panel testing from one patient sample. The assay can be used on Roche's modular analyzers-- cobas 8000, cobas 6000, cobas 4000, and Elecsys 2010 platforms.

First generation assays frequently over-estimate testosterone in the female matrix. This effect is variable and cannot be predicted for any given sample. The Elecsys testosterone II assay was developed as part of Roche's commitment to improvement and in response to customer feedback about high recovery with female samples, which did not fit the clinical picture.

Roche offers a large endocrinology menu, which includes fully automated DHEAS, sex hormone-binding globulin (SHBG), anti-thyroid-stimulating hormone-receptor antibody (TSHR) and adrenocorticotropin hormone (ACTH) assays.

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