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

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY Clinical biochemistry Pub Date : 2025-01-01 DOI:10.1016/j.clinbiochem.2024.110863

Emily Shang , Hilario Agustin , Jason K.Y. Lee , Matt Scheidegger , JoAnna Jones , Charbel Abou-Diwan , Joe M. El-Khoury , Jieli Li

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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.

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评估西门子 Atellica AMH 检测法，并与罗氏、贝克曼和安氏实验室进行比较。

背景：抗缪勒氏管激素（AMH）是卵巢储备和对生育治疗反应的重要标志物。然而，由于缺乏标准化方法，测定间存在差异。本研究评估了新型西门子Healthineers Atellica IM AMH测定与现有测定（Beckman DxI 600 Access、Roche cobas Elecsys® e801和Ansh Labs AMH ELISA）的性能：我们使用所有四种检测方法测量了120份残留血清样本中的AMH浓度，这些样本来自接受常规AMH检测的患者。采用Passing-Bablok回归法和Bland-Altman法进行数据分析：结果：西门子Healthineers Atellica IM测定与贝克曼DxI（斜率：1.07，R2：0.9881）有很强的相关性，但正偏倚很小。相反，与贝克曼 DxI 相比，罗氏 cobas Elecsys® e801 检测试剂盒显示出负偏倚（斜率：0.74，R2：0.9696），而 Ansh Labs 检测试剂盒则显示出显著的正偏倚，在 AMH 浓度较高时变异性增加：总的来说，西门子医疗Atellica IM测定法有望成为AMH测定的替代方法，与现有测定法具有良好的相关性。然而，所有检测方法之间都存在差异，这凸显了特定检测方法的解释对于准确临床评估的重要性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical biochemistry 医学-医学实验技术

CiteScore

5.10

自引率

0.00%

发文量

151

审稿时长

25 days

期刊介绍： Clinical Biochemistry publishes articles relating to clinical chemistry, molecular biology and genetics, therapeutic drug monitoring and toxicology, laboratory immunology and laboratory medicine in general, with the focus on analytical and clinical investigation of laboratory tests in humans used for diagnosis, prognosis, treatment and therapy, and monitoring of disease.