Garnett Emily R, Jariwala Purviben, Rector Kesha, Gibbons William E, Zarutskie Paul W, Devaraj Sridevi
Department of Pathology & Immunology, Baylor College of Medicine, Houston, TX, 77030, USA.
Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, TX, 77030, USA.
Pract Lab Med. 2019 Sep 27;17:e00140. doi: 10.1016/j.plabm.2019.e00140. eCollection 2019 Nov.
Anti-Müllerian hormone (AMH) is increasingly used as a biomarker of ovarian reserve in clinical practice, and is used both for management of fertility treatments and prediction of menopause. We sought to validate the newly FDA-approved Ansh Laboratories MenoCheck picoAMH ELISA on the Dynex-DS2 platform for clinical use in our obstetrics and gynecology center.
Validation of the picoAMH ELISA on the Dynex-DS2 was performed according to CLSI guidelines. Intra- and inter-assay CV, assay linearity, and method comparison studies were carried out to verify assay precision and accuracy. The manufacturer's reference range was verified using 26 volunteer samples, and interference for hemolysis, lipemia, icterus, and biotin was evaluated. picoAMH results were additionally correlated with antral follicle count by ultrasound.
Intra- and inter-assay CV of the picoAMH assay on the DS2 was ≤4% and the assay was linear between concentrations of 0.0067-16.24 ng/mL (0.048-116.0 pmol/L) AMH. Method comparison was performed with the manufacturer's laboratory and indicated good correlation, with Deming regression yielding slope of 0.928 and intercept of -0.0421. The assay displayed no significant interference from hemolysis (1000 mg/dL), lipemia (2000 mg/dL), conjugated bilirubin (66 mg/dL), or biotin (10,000 ng/mL). Measurement of AMH on the DS2 was also correlated with antral follicle count, with = 0.7128.
Our results indicate that the picoAMH ELISA on the DS2 has good analytical performance suitable for clinical use.
抗苗勒管激素（AMH）在临床实践中越来越多地用作卵巢储备的生物标志物，用于生育治疗管理和绝经预测。我们试图在Dynex-DS2平台上验证新获得美国食品药品监督管理局（FDA）批准的安氏实验室MenoCheck picoAMH ELISA试剂盒，以便在我们的妇产科中心用于临床。
根据临床和实验室标准协会（CLSI）指南对Dynex-DS2上的picoAMH ELISA试剂盒进行验证。进行批内和批间变异系数（CV）、分析线性和方法比较研究，以验证分析的精密度和准确性。使用26份志愿者样本验证制造商的参考范围，并评估溶血、脂血、黄疸和生物素的干扰情况。此外，通过超声将picoAMH结果与窦卵泡计数进行相关性分析。
DS2上picoAMH检测的批内和批间CV≤4%，且在AMH浓度为0.0067 - 16.24 ng/mL（0.048 - 116.0 pmol/L）之间检测呈线性。与制造商实验室进行方法比较，结果显示相关性良好，Deming回归得出斜率为0.928，截距为 -0.0421。该检测对溶血（1000 mg/dL）、脂血（2000 mg/dL）、结合胆红素（66 mg/dL）或生物素（10,000 ng/mL）均无显著干扰。DS2上AMH的测量值也与窦卵泡计数相关，r = 0.7128。
我们的结果表明，DS2上的picoAMH ELISA试剂盒具有良好的分析性能，适合临床使用。
