Siemens Healthineers announced that its Atellica IM Testosterone II (TSTII) assay has received certification through the Centers for Disease Control and Prevention’s (CDC) Hormone Standardization Program for Total Testosterone (HoSt-TT). This proves that the test results of the Atellica IM TSTII immunoassay are comparable to high performance liquid chromatography combined with tandem mass spectrometry, which is considered the gold standard analytical approach. The Atellica IM TSTII assay, available for Atellica IM and Atellica CI analyzers, is the only fully automated immunoassay with CDC HoSt-TT certification, which has been maintained continuously since 2019. An evaluation of the performance of this assay was recently published in The Journal of Clinical Endocrinology & Metabolism.
Testosterone is an important steroid hormone with important roles in sexual development, reproductive function, musculoskeletal health, and bone metabolism. Accurate measurement of testosterone is clinically important, and abnormal levels can be associated with a variety of endocrine, metabolic, reproductive, and tumor conditions. 2 In clinical and research settings, measurements of total testosterone are often considered alongside other biochemical and clinical factors when assessing androgenic status. High-quality, standardized testosterone assays play a critical role in supporting consistent measurement and interpretation across diverse patient populations, including male, female, and pediatric patients.
In women and children, testosterone levels are naturally low, making it difficult to measure accurately. The Atellica IM TSTII Testosterone Assay is currently the only fully automated immunoassay with ongoing CDC HoSt-TT certification, providing a suitable, widely used, routine alternative to specialized testing methods, allowing clinicians to support more patients with confidence. ”
Dr. Ross Molinaro, Head of Evidence for Medical Value and Diagnosis, Siemens Healthneers
Certification through the HoSt-TT program ensures traceability, minimizes variability, and supports compliance with Endocrine Society and American Urological Association guidelines. Continuous certification ensures long-term consistency and reliable clinical interpretation of total testosterone results.
“CDC’s Clinical Hormone Standardization Program standardizes total testosterone testing so that results are accurate, comparable, and clinically meaningful no matter where it is performed.said Scott D. Isaacs, MD, FACP, FACE, adjunct professor of medicine at Emory University School of Medicine. “CDC HoSt-TT reduces variation between laboratories by calibrating assays to a common reference method and applying rigorous performance standards. In clinical practice, this level of standardization improves quality of care. When reviewing total testosterone results, regardless of where the test was performed, you can trust that they reflect the same analytical standards, allowing for more consistent diagnostic and treatment decisions.”
