Evaluation of Siemens Atellica AMH assay and comparison with Roche, Beckman and Ansh Labs

Clin Biochem. 2024 Dec 13:135:110863. doi: 10.1016/j.clinbiochem.2024.110863. Online ahead of print.

Abstract

Background: Anti-Müllerian hormone (AMH) is an important marker for ovarian reserve and response to fertility treatments. However, interassay variability exists due to the lack of a standardized method. This study evaluates the performance of the new Siemens Healthineers Atellica IM AMH assay against established assays (Beckman DxI 600 Access, Roche cobas Elecsys® e801, and Ansh Labs AMH ELISA).

Methods: We measured AMH concentrations in 120 residual serum samples from patients presenting for routine AMH testing using all four assays. Passing-Bablok regression and Bland-Altman method were used for data analysis.

Results: The Siemens Healthineers Atellica IM assay demonstrated strong correlation with Beckman DxI (slope: 1.07, R2: 0.9881) but showed a minimal positive bias. Conversely, the Roche cobas Elecsys® e801 assay exhibited a negative bias compared to Beckman DxI (slope: 0.74, R2: 0.9696), while the Ansh Labs assay demonstrated a significant positive bias with increasing variability at higher AMH concentrations.

Conclusion: Overall, the Siemens Healthineers Atellica IM assay shows promise as an alternative method for AMH measurement, demonstrating good correlation with established assays. However, differences were observed between all assays, highlighting the importance of assay-specific interpretation for accurate clinical assessment.

Keywords: Anti-Müllerian hormone; Beckman DxI; Immunoassay; Roche cobas Elecsys® e801; Siemens Healthineers Atellica.