Lumipulse 抗缪勒管激素测定的分析评估。
Analytical Evaluation of Lumipulse Anti-Mullerian Hormone Assay.
出版信息
Clin Lab. 2021 Jun 1;67(6). doi: 10.7754/Clin.Lab.2020.200737.
BACKGROUND
The measurement of serum Anti-Mullerian hormone (AMH) is used in daily practice to estimate the ovarian reserve in women.
METHODS
The aim of this study was to evaluate the new Lumipulse AMH® immunoassay (Fujirebio) with regard to the reliability with two preexisting assays: Elecsys AMH Plus® (cobas®, Roche) and Vidas AMH® (bioMérieux). Precision of Lumipulse AMH was evaluated on the Lumipulse G600 II using the manufacturer's quality controls. Thirty-three samples were used for method comparison.
RESULTS
Lumipulse AMH repeatability and intermediate precision did not exceed 4.1 %. There was a proportional bias between Lumipulse and Cobas method and between Lumipulse and Vidas whereas a good agreement was found between Cobas and Vidas.
CONCLUSIONS
Lumipulse AMH assay demonstrated good precision and good agreement with the two other methods up to 6 ng/mL. Nevertheless, this study shows the need to standardize AMH assays to improve the comparability of the methods.
背景
血清抗苗勒管激素（AMH）的测定用于日常实践中评估女性的卵巢储备功能。
方法
本研究旨在评估新的 Lumipulse AMH®免疫分析（富士瑞比奥）与两种现有检测方法的可靠性：Elecsys AMH Plus®（罗氏 cobas®）和 Vidas AMH®（生物梅里埃）。使用制造商的质量控制品评估 Lumipulse AMH 在 Lumipulse G600 II 上的精密度。用 33 个样本进行方法比较。
结果
Lumipulse AMH 的重复性和中间精密度不超过 4.1%。Lumipulse 与 Cobas 方法之间以及 Lumipulse 与 Vidas 之间存在比例偏差，而 Cobas 与 Vidas 之间存在良好的一致性。
结论
Lumipulse AMH 检测法在 6ng/mL 以下显示出良好的精密度和与另外两种方法的良好一致性。然而，本研究表明需要标准化 AMH 检测法以提高方法的可比性。
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