Objective

To determine a cutoff for the Elecsys AMH Plus immunoassay (Roche Diagnostics International Ltd, Rotkreuz, Switzerland) to identify polycystic ovarian morphology (PCOM), a polycystic ovary syndrome (PCOS) criterion.

Design

The AMH Protein in Humans for polycystic ovaRian mOrphology DIagnostic TEsting (APHRODITE) study was a retrospective, multicenter, case-control study. The serum antimüllerian hormone (AMH) level was measured using the Elecsys AMH Plus immunoassay. The antral follicle count was determined using transvaginal ultrasound. An AMH cutoff was derived and validated in separate cohorts with cases of PCOS with full phenotype A (oligo/anovulation, hyperandrogenism, and PCOM) versus that with controls. Exploratory analyses of age and PCOS phenotype were performed.

Setting

Not applicable.

Patient(s)

Polycystic ovary syndrome-positive (PCOS A–D per the Rotterdam criteria) and PCOS-negative women aged 25–45 years.

Intervention(s)

None.

Main Outcome Measure(s)

A validated cutoff for AMH using the Elecsys AMH Plus assay for PCOM.

Result(s)

In the validation cohort (455 cases and 500 controls), an AMH cutoff of 3.2 ng/mL (23 pmol/L) resulted in a sensitivity of 88.6% (95% confidence interval [CI] 85.3–91.3) and specificity of 84.6% (95% CI 81.1–87.7) for PCOM diagnosis as well as an area under the receiver-operator characteristic curve of 93.6% (95% CI 92.2–95.1). In women aged 25–35 years, the sensitivity and specificity for the cutoff were 88.5% and 80.3%, respectively, versus 77.8% and 90.1%, respectively, in women aged 36–45 years. The results were consistent across PCOS phenotypes A–D.

Conclusion(s)

The Elecsys AMH Plus immunoassay, with a cutoff of 3.2 ng/mL (23 pmol/L), is a robust method for identifying PCOM to aid in PCOS diagnosis.

中文翻译：

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确定多囊卵巢形态的抗苗勒管激素

客观的

确定 Elecsys AMH Plus 免疫测定（Roche Diagnostics International Ltd，Rotkreuz，瑞士）的临界值，以识别多囊卵巢形态学 (PCOM)，这是一种多囊卵巢综合征 (PCOS) 标准。

设计

用于多囊卵巢形态学诊断测试 (APHRODITE) 研究的人类 AMH 蛋白是一项回顾性、多中心、病例对照研究。使用 Elecsys AMH Plus 免疫测定法测量血清抗苗勒管激素 (AMH) 水平。使用经阴道超声确定窦卵泡计数。AMH 截断值是在单独的队列中得出并验证的，其中 PCOS 病例具有完全表型 A（寡/无排卵、雄激素过多症和 PCOM）与对照组相比。对年龄和 PCOS 表型进行了探索性分析。

环境

不适用。

耐心）

多囊卵巢综合征阳性（根据鹿特丹标准的 PCOS A-D）和 25-45 岁的 PCOS 阴性女性。

干预措施

没有任何。

主要观察指标）

使用 Elecsys AMH Plus 检测 PCOM 验证 AMH 的临界值。

结果）

在验证队列（455 例病例和 500 例对照）中，3.2 ng/mL (23 pmol/L) 的 AMH 临界值导致 88.6%（95% 置信区间 [CI] 85.3-91.3）的敏感性和 84.6% 的特异性(95% CI 81.1–87.7) 用于 PCOM 诊断以及接受者-操作者特征曲线下面积为 93.6% (95% CI 92.2–95.1)。在 25-35 岁女性中，临界值的敏感性和特异性分别为 88.5% 和 80.3%，而在 36-45 岁女性中分别为 77.8% 和 90.1%。结果在 PCOS 表型 A-D 中是一致的。

结论

Elecsys AMH Plus 免疫测定法的临界值为 3.2 ng/mL (23 pmol/L)，是识别 PCOM 以辅助 PCOS 诊断的可靠方法。