Multicenter analytical performance evaluation of a fully automated anti-Mullerian hormone assay and reference interval determination

Objectives: Anti-Mullerian hormone (AMH) is an established biomarker for assessing ovarian reserve and predicting response to controlled ovarian stimulation. Its routine clinical use is hampered by the variability and low-throughput of available enzyme-linked immunosorbent assays (ELISA). The presented study examined if a fully automated AMH electrochemiluminescence assay (ECLIA; Elecsys (R) AMH assay, Roche Diagnostics) was suitable for measuring AMH levels in healthy women and in those diagnosed with polycystic ovary syndrome (PCOS). Design and methods: Five European laboratories evaluated the Elecsys (R) AMH assay independently under routine conditions over eight months. Within-run imprecision, repeatability, intermediate precision, linearity and functional sensitivity were assessed. The Elecsys (R) AMH assay was compared to a manual ELISA microtiter plate format test (AMH Gen II ELISA, modified version; Beckman Coulter Inc.) using 1729 routine serum samples. AMH reference intervals were determined in 887 healthy women with regular menstrual cycle aged 20-50 years, and 149 women diagnosed with PCOS. Results: The fully automated Elecsys (R) AMH assay showed excellent precision, linearity, and functional sensitivity. The coefficient of variation was 1.8% for repeatability and 4.4% for intermediate precision. Values measured with the Elecsys (R) AMH assay were highly correlated with the manual ELISA method (modified version) but 24-28% lower. Reference intervals showed the expected AMH decline with age in healthy women and increased AMH levels in women with PCOS. Conclusions: The Elecsys (R) AMH assay demonstrated good precision under routine conditions, and is suitable for determining AMH levels in serum and lithium-heparin plasma. (C) 2015 The Authors. The Canadian Society of Clinical Chemists. Published by Elsevier Inc.