School of Medicine, University of Glasgow, Glasgow, United Kingdom.
NVICTA Fertility and Reproductive Center, Gdansk, Poland; Department of Nursing, Medical University, Gdansk, Poland.
Fertil Steril. 2015 Oct;104(4):1016-1021.e6. doi: 10.1016/j.fertnstert.2015.06.024. Epub 2015 Jul 14.
To compare new automated antimüllerian hormone (AMH) assay performance characteristics from the new automated Elecsys AMH (Roche; Elecsys) and Access AMH (Beckman Coulter; Access) assays with the existing AMH Gen II ELISA (enzyme-linked immunosorbent assay; Gen II; Beckman Coulter) and AMH ELISA (Ansh Labs) assays.
Prospective assay evaluation.
University-affiliated clinical chemistry laboratory.
PATIENT(S): Patients referred for serum AMH measurement (n = 83) before start of in vitro fertilization cycle between September 2014 and October 2014.
INTERVENTION(S): None.
MAIN OUTCOME MEASURE(S): Serum AMH concentration.
RESULT(S): Intra-assay coefficients of variation were low; Ansh ≤ 9.0%; Gen II ≤ 5.8%; Access ≤ 10.7%; and Elecsys ≤ 2.8%. The Passing-Bablok regression equations (pmol/L) were y (Access) = 0.128 + (0.781 × Gen II); and y (Access) = 0.302 + (0.742 x Ansh). For y (Elecys) = 0.087 + (0.729 x Gen II) and y (Elecys) = 0.253 + (0.688 x Ansh Labs). For y (Elecys) = 0.943 - (0.037 × Access). For all the assays, AMH exhibited a moderate positive correlation with AFC (r = 0.62-0.64); number of cumulus oocyte complexes (r = 0.60-0.64); and metaphase II oocytes (r = 0.48-0.50). Accuracy of pregnancy prediction, as determined by area under the receiver operating characteristic curve, was uniformly low for all assays (0.62-0.63).
CONCLUSION(S): The novel automated assays exhibit strong concordance in calibration, but derived values are substantially lower than those obtained from pre-existing assays, with assay-specific interpretation required for routine clinical use. These results highlight the need for an international standard of measurement of AMH.
比较新的自动化抗缪勒管激素(AMH)检测方法在新的 Elecsys AMH(罗氏;Elecsys)和 Access AMH(贝克曼库尔特;Access)检测与现有的 AMH Gen II ELISA(酶联免疫吸附测定;Gen II;贝克曼库尔特)和 AMH ELISA(Ansh 实验室)检测中的性能特点。
前瞻性检测评估。
大学附属临床化学实验室。
2014 年 9 月至 2014 年 10 月体外受精周期前因血清 AMH 检测而转介的患者(n = 83)。
无。
血清 AMH 浓度。
日内变异系数较低;Ansh ≤ 9.0%;Gen II ≤ 5.8%;Access ≤ 10.7%;Elecsys ≤ 2.8%。Passing-Bablok 回归方程(pmol/L)为 y(Access)= 0.128 +(0.781 × Gen II);y(Access)= 0.302 +(0.742 x Ansh)。对于 y(Elecys)= 0.087 +(0.729 x Gen II)和 y(Elecys)= 0.253 +(0.688 x Ansh Labs)。y(Elecys)= 0.943 -(0.037 × Access)。所有检测均显示 AMH 与 AFC(r = 0.62-0.64)、卵丘卵母细胞复合物数(r = 0.60-0.64)和中期 II 卵母细胞(r = 0.48-0.50)呈中度正相关。通过受试者工作特征曲线下面积确定的妊娠预测准确性在所有检测中均较低(0.62-0.63)。
新的自动化检测在定标方面具有很强的一致性,但衍生值明显低于现有检测获得的值,需要对每种检测进行特定的解释,才能用于常规临床使用。这些结果突出表明需要建立 AMH 的国际测量标准。