Siemens Healthineers has announced that its Atellica IM Testosterone II (TSTII) assay has achieved certification through the Centers for Disease Control and Prevention (CDC) Hormone Standardization Program for Total Testosterone (HOST-TT). This certifies that the test results of the Atellica IM TSTII immunoassay are equivalent to high performance liquid chromatography coupled with tandem mass spectrometry, which is considered the gold-standard analytical approach. The Atellica IM tSTII assay, available on the Atellica IM and Atellica CI analyzers, is the only fully automated immunoassay with CDC HOST-TT certification, which it has maintained continuously since 2019. Evaluation of the assay’s performance was recently published in The Journal of Clinical Endocrinology & Metabolism.
Testosterone is a major steroid hormone that plays essential roles in sexual development, reproductive function, musculoskeletal health, and bone metabolism. Accurate measurement of testosterone is clinically important, as abnormal levels may be associated with a wide range of endocrine, metabolic, reproductive, and oncological conditions. 2 In clinical and research settings, total testosterone measurements are often considered along with other biochemical and clinical factors when evaluating androgen status. High-quality, standardized testosterone tests play a vital role in supporting consistent measurement and interpretation across diverse patient populations, including male, female, and pediatric patients.
For women and children, where testosterone levels are naturally low, making accurate measurements challenging, the Atellica IM TSTII Testosterone Assay is currently the only fully automated immunoassay with continued CDC Host-TT validation, offering a suitable and widely used routine method that is an alternative to an otherwise specialized testing method, enabling physicians to support patients more confidently.
Ross Molinaro, PhD, Head of Evidence for Medical Value and Diagnostics, Siemens Healthineers
Certification through the HoSt-TT program ensures traceability, reduces variability, and supports compliance with Endocrine Society and American Urological Association guidelines. Ongoing validation ensures longitudinal stability and reliable clinical interpretation of total testosterone results.
“CDC’s Clinical Hormone Standardization Program standardizes total testosterone assays so that results are accurate, comparable, and clinically meaningful, wherever they are performed.said Scott D. Isaacs, MD, FACP, FACE, assistant professor in the department of medicine at Emory University School of Medicine. “By calibrating the test to a common reference method and applying stringent performance criteria, the CDC HoSt-TT minimizes inter-laboratory variability. In clinical practice, this level of standardization improves the quality of care. When I review a total testosterone result, I can be confident that it reflects the same analytical standard no matter where it is made, allowing for more consistent diagnostic and treatment decisions.”
