September 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.
An evaluation of the assay’s performance was published in the Journal of Clinical Endocrinology and Metabolism (Li J, et al. 2026;111[7]:1863–1873). The assay is available on Atellica IM and CI analyzers.
Siemens Healthineers, 800-888-7436