CDC certification expands access to gold‑standard equivalent testosterone testing from Siemens Healthineers

Siemens Healthineers has achieved continued certification from the Centers for Disease Control and Prevention (CDC) Hormone Standardization Program for Total Testosterone (HoSt-TT) for its Atellica IM Testosterone II (TSTII) assay, confirming that this fully automated immunoassay delivers total testosterone results equivalent to high performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS), the recognized gold standard analytical method.

The Atellica IM TSTII assay, available on the Atellica IM and Atellica CI Analyzers, is currently the only immunoassay with CDC HoST-TT certification.

Gold standard equivalent testosterone testing on automated analyzers

The CDC HoST-TT certification confirms that the Atellica IM TSTII immunoassay is aligned with specialized mass spectrometry testing methods, specifically HPLC-MS/MS, which are widely regarded as the reference approach for total testosterone measurement. This alignment supports laboratories in delivering high-quality, standardized testosterone results without relying solely on specialty mass spectrometry services.

The Atellica IM TSTII assay offers a fully automated, routine testing solution on the Atellica IM and Atellica CI Analyzers. As a broadly available and economical immunoassay, it helps expand access to accurate total testosterone testing for patients and laboratories, while maintaining performance comparable to specialized reference methods.

An evaluation of the assay’s performance was recently published in The Journal of Clinical Endocrinology & Metabolism, further supporting the clinical and analytical robustness of the Atellica IM TSTII assay.

Clinical importance of accurate total testosterone measurement

Testosterone is a key steroid hormone with essential roles in sexual development, reproductive function, musculoskeletal health, and bone metabolism. Accurate measurement of total testosterone is clinically important because abnormal levels may be associated with a wide range of endocrine, metabolic, reproductive, and oncologic conditions.

In both clinical practice and research, total testosterone results are often interpreted alongside other biochemical markers and clinical findings to evaluate androgen status. High-quality, standardized assays are critical to ensure consistent measurement and interpretation across diverse patient populations, including male, female, and pediatric patients.

Supporting low-level testosterone testing in women and children

For women and children, naturally low testosterone concentrations can make accurate measurement challenging. The Atellica IM TSTII Testosterone assay addresses this need as the only fully automated immunoassay with sustained CDC HoST-TT certification, providing a suitable and widely used routine method that serves as an alternative to specialty testing.

Standardization, traceability, and guideline alignment

Certification through the CDC HoST-TT program ensures traceability to a common reference method, minimizes inter-laboratory variability, and supports compliance with Endocrine Society and American Urological Association guidelines for testosterone testing. Ongoing certification is essential for maintaining longitudinal consistency, allowing clinicians to compare results over time and across different testing sites with confidence.

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