May 4, 2026—Siemens Healthineers’ Atellica IM Testosterone II assay has achieved certification through the Centers for Disease Control and Prevention hormone standardization program for total testosterone, confirming that the Atellica IM TSTII immunoassay’s test results are equivalent to high-performance liquid chromatography coupled with tandem mass spectrometry. Certification ensures traceability, minimizes variability, and supports compliance with Endocrine Society and American Urological Association guidelines.
“For women and children, testosterone levels are naturally low, which makes accurate measurement challenging,” Ross Molinaro, PhD, head of medical value and evidence for diagnostics at Siemens Healthineers, said in a release. “The Atellica IM TSTII Testosterone assay is currently the only fully automated immunoassay with sustained CDC HoSt-TT certification, offering a suitable and widely used routine method that is alternative to an otherwise specialty testing method, enabling clinicians to confidently support more patients.”
An evaluation of the assay’s performance was published in February in the Journal of Clinical Endocrinology and Metabolism (Li J, et al. Published online Feb. 19, 2026). The assay is available on the Atellica IM and CI analyzers.