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

E Anckaert, M Öktem, A Thies, M Cohen-Bacrie, N M P Daan, Johan Schiettecatte, C Müller, D Topcu, A Gröning, F Ternaux, C Engel, S Engelmann, C Milczynski

Research output: Contribution to journalArticle

64 Citations (Scopus)

Abstract

Objectives

Anti-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 methods

Five 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 20–50 years, and 149 women diagnosed with PCOS.

Results

The 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.

Conclusions

The Elecsys® AMH assay demonstrated good precision under routine conditions, and is suitable for determining AMH levels in serum and lithium-heparin plasma.
Original languageEnglish
Pages (from-to)260-267
Number of pages8
JournalClinical Biochemistry
Volume49
Issue number3
DOIs
Publication statusPublished - Feb 2016

Keywords

  • ECLIA
  • PCOS
  • AMH

Fingerprint

Dive into the research topics of 'Multicenter analytical performance evaluation of a fully automated anti-Müllerian hormone assay and reference interval determination'. Together they form a unique fingerprint.

Cite this