CDC HoSt-TT Certification for Siemens Healthineers Total Testosterone Test Expands Patient Access to Gold Standard Equivalent Results

Why It Matters

Standardized, high‑accuracy testosterone testing enables clinicians to diagnose and treat endocrine disorders consistently, expanding reliable access beyond specialty labs. This boosts laboratory efficiency and supports guideline‑driven care for diverse patient groups.

Key Takeaways

• Atellica IM TSTII assay earned CDC HoSt‑TT certification.
• Only fully automated immunoassay with continuous CDC certification since 2019.
• Provides gold‑standard equivalent results to LC‑MS/MS for testosterone.
• Enhances test accuracy for women, children, and diverse populations.
• Supports Endocrine Society and AUA guideline compliance across labs.

Pulse Analysis

The CDC Hormone Standardization Program (HoSt‑TT) certification signals that Siemens Healthineers’ Atellica IM Testosterone II assay delivers results comparable to high‑performance liquid chromatography‑tandem mass spectrometry, the benchmark for testosterone measurement. Achieving this level of standardization is especially critical for low‑concentration samples, such as those from women and children, where assay imprecision can obscure clinical interpretation. By anchoring its immunoassay to a CDC‑endorsed reference, Siemens provides laboratories with a reliable, fully automated alternative to costly, labor‑intensive LC‑MS/MS workflows.

For clinical laboratories, the certification translates into operational efficiencies and cost savings. Automated platforms like Atellica IM and CI can process high volumes with minimal hands‑on time, reducing turnaround while maintaining analytical fidelity. The alignment with Endocrine Society and American Urological Association guidelines further simplifies compliance, allowing health systems to adopt a single, validated test for total testosterone across adult, pediatric, and female cohorts. This uniformity improves diagnostic confidence, informing treatment decisions for conditions ranging from hypogonadism to androgen‑dependent cancers.

The broader diagnostic market is trending toward assay standardization to mitigate inter‑lab variability and enhance patient outcomes. Siemens’ achievement may pressure competitors to pursue similar CDC certifications, accelerating a shift away from fragmented specialty testing. As more hormone assays achieve HoSt‑TT status, clinicians can expect a more cohesive laboratory landscape, where results are interchangeable regardless of location. Ultimately, this fosters equitable care, supports research reproducibility, and positions Siemens Healthineers as a leader in standardized diagnostic solutions.