Abstract
ObjectivesAnti-Müllerian 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® AMH assay, Roche Diagnostics) was suitable for measuring AMH levels in healthy women and in those diagnosed with polycystic ovary syndrome (PCOS). Design and methodsFive European laboratories evaluated the Elecsys® AMH assay independently under routine conditions over eight months. Within-run imprecision, repeatability, intermediate precision, linearity and functional sensitivity were assessed. The Elecsys® 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 20–50years, and 149 women diagnosed with PCOS. ResultsThe fully automated Elecsys® 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® 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. ConclusionsThe Elecsys® AMH assay demonstrated good precision under routine conditions, and is suitable for determining AMH levels in serum and lithium-heparin plasma.
Highlights
Anti-Müllerian hormone (AMH) is a dimeric glycoprotein that belongs to the transforming growth factor β family [1]
The presented study examined if a fully automated AMH electrochemiluminescence assay (ECLIA; Elecsys® AMH assay, Roche Diagnostics) was suitable for measuring AMH levels in healthy women and in those diagnosed with polycystic ovary syndrome (PCOS)
AMH reference intervals were determined in 887 healthy women with regular menstrual cycle aged 20–50 years, and 149 women diagnosed with PCOS
Summary
Anti-Müllerian hormone (AMH) is a dimeric glycoprotein that belongs to the transforming growth factor β family [1]. The NICE guideline states that AMH concentration of ≤ 0.75 ng/ml (≤5.4 pmol/L) indicates a low ovarian response to stimulation, whereas AMH concentration ≥3.50 ng/ml (≥ 25.0 pmol/L) indicates a high response [12]. It follows that precise and accurate AMH measurement in these intervals is a prerequisite for reliable interpretation of AMH results in a clinical setting. Limited assay reproducibility (precision) was observed with the AMH Gen II ELISA assay, unmodified version (Beckman Coulter) [14,15,16]. Beckman Coulter modified the assay to include a pre-dilution step to avoid interference from complement binding (AMH Gen II ELISA, modified version). There is a need for a precise and reliable fully automated AMH assay [6]
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