The certification verifies that the automated immunoassay provides results equivalent to the gold standard method for measuring total testosterone.
Siemens Healthineers announced its Atellica IM Testosterone II (TSTII) assay achieved certification through the Centers for Disease Control and Prevention (CDC) Hormone Standardization Program for Total Testosterone (HoSt-TT).
The certification confirms that the Atellica IM TSTII immunoassay results are equivalent to high performance liquid chromatography coupled with tandem mass spectrometry, which is the gold standard analytical approach. The assay, available on the Atellica IM and Atellica CI Analyzers, is the only fully automated immunoassay to maintain this certification continuously since 2019, according to the company.
“For women and children, testosterone levels are naturally low, which makes accurate measurement challenging,” says Ross Molinaro, PhD, head of medical value and evidence for diagnostics at Siemens Healthineers, 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.”
Testosterone is a steroid hormone that plays a role in sexual development, reproductive function, and bone metabolism. Accurate measurement is clinically significant because abnormal levels are associated with various endocrine, metabolic, reproductive, and oncologic conditions.
“The CDC’s Clinical Hormone Standardization Programs standardize the total testosterone assay so that results are accurate, comparable, and clinically meaningful wherever they are performed,” says Scott D Isaacs, MD, adjunct professor for the department of medicine at Emory University School of Medicine, in a release. “By calibrating assays to a common reference method and enforcing stringent performance criteria, CDC HoSt-TT reduces inter-laboratory variability.”
The HoSt-TT program ensures traceability and supports compliance with guidelines from the Endocrine Society and the American Urological Association. An evaluation of the assay’s performance was recently published in The Journal of Clinical Endocrinology & Metabolism.
