VOLUME 116, ISSUE 4, P1149-1157
Authors:
Alexandra Dietz de Loos, M.D., Martin Hund, Ph.D., Katharina Buck, Ph.D., Cindy Meun, M.D., Johanna Sillman, Ph.D., Joop S.E. Laven, M.D.
Abstract:
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.
