Department Clinical Biochemistry, Glasgow Royal Infirmary, Glasgow, UK.
Ann Clin Biochem. 2011 Jul;48(Pt 4):370-3. doi: 10.1258/acb.2011.010172. Epub 2011 May 31.
The measurement of anti-Müllerian hormone (AMH) has been by two commercial enzyme-linked immunosorbent (ELISA) assays: Diagnostics Systems Laboratory (DSL 10-14400) and Immunotech (A11893 IVD EU only). Beckman Coulter has developed a new assay for AMH (AMH Gen II A79765), which uses the DSL antibodies but is standardized to the Immunotech calibration. As a result, comparative data are urgently required between the old DSL assay and its replacement AMH Gen II.
An evaluation of the AMH Gen II assay was performed at three sites, each with extensive experience of measuring circulating AMH in the adult female. Results were compared with the original DSL ELISA assay. The analysis was performed on a total of 271 patients' samples, approximately 90 at each site.
Performance characteristics were evaluated for the AMHGen II assay. Linearity was acceptable with observed values close to the expected (mean recovery 106.3%). The functional sensitivity (20% coefficient of variation), calculated from precision profile data, was 1.5 pmol/L. Within- and between-batch imprecision, assessed over the concentration range of 5-70 pmol/L, were 5.3-11.4% and 3.8-17.3%, respectively. There was good agreement between assays with a Bablok-Passing regression equation AMH Gen II = 1.40 DSL-0.62 pmol/L, r = 0.96, n = 271.
Our results demonstrate that similar precision and excellent between-assay agreement should be obtained when laboratories change from the DSL to the AMH Gen II ELISA and they should expect an increase in AMH values of approximately 40%.
抗苗勒氏管激素（AMH）的测量一直采用两种商业酶联免疫吸附（ELISA）检测法：诊断系统实验室（DSL 10-14400）和免疫技术（A11893 仅限欧盟的体外诊断）。贝克曼库尔特公司开发了一种新的 AMH 检测法（AMH Gen II A79765），该检测法使用 DSL 抗体，但标准化为免疫技术的校准。因此，迫切需要新旧 DSL 检测法之间的比较数据。
在三个具有丰富成年女性循环 AMH 测量经验的地点对 AMH Gen II 检测法进行了评估。结果与原始的 DSL ELISA 检测法进行了比较。分析共使用了 271 名患者的样本，每个地点约 90 名。
评估了 AMHGen II 检测法的性能特征。线性情况可接受，观察值接近预期值（平均回收率为 106.3%）。从精密度概况数据计算得出的功能灵敏度（20%变异系数）为 1.5 pmol/L。在 5-70 pmol/L 的浓度范围内，批内和批间精密度分别为 5.3-11.4%和 3.8-17.3%。两种检测法之间具有良好的一致性，Bablok 过回归方程为 AMH Gen II = 1.40 DSL-0.62 pmol/L，r = 0.96，n = 271。
我们的结果表明，实验室从 DSL 转换为 AMH Gen II ELISA 时，应获得类似的精密度和出色的检测法之间的一致性，并且预计 AMH 值将增加约 40%。
