Abstract
Anti-Müllerian Hormone (AMH) is a 140 kDa homodimeric glycoprotein consisting of two identical subunits linked by disulphide bonds and is synthesised by the testes and ovaries. Its clinical applications are prediction of ovarian response and gonadotropin dose selection upon in vitro fertilization. In males, AMH is used to investigate sexual developmental disorders and gonadal function. AMH is commonly assayed by enzyme-linked immunosorbent assay or automated immunoassay formats that show variation between methods. This review applies fundamental chemical pathology concepts to explain the observed analytical variation of AMH measurement. We examine the lack of standardisation between AMH assays, the impact of antibody design on variable measurements, consider the analytical detection of AMH isoforms, review analytical interference in AMH measurement, and briefly assess systematic bias between AMH assays. The improved attempt at standardising AMH measurement by the recent approval of a WHO Reference Reagent offers promise for harmonising immunoassay results and establishing consensus medical cut-off points for AMH in disease. Standardisation, however, will need to redress the issue of poor commutability of standard reference material and further assign a standard reference procedure to quantify AMH standard reference material. The improvement of the analytical phase of AMH testing will support harmonised method development and patient care.
Highlights
Müllerian Inhibiting Substance (MIS), known as Anti-Müllerian Hormone (AMH), is a dimeric glycoprotein that is a member of the transforming growth factor-beta superfamily [1]
This is illustrated by comparison laboratory evaluation data between the AMH Gen II enzyme-linked immunosorbent assay (ELISA) assay and the Elecys® AMH assay in orthotopic transplantation of ovarian tissue after gonadotoxic treatment [46]
AMH between-method variability can be ascribed to various processes in the analytical phase of testing
Summary
Müllerian Inhibiting Substance (MIS), known as Anti-Müllerian Hormone (AMH), is a dimeric glycoprotein that is a member of the transforming growth factor-beta superfamily [1]. Manufacturers of AMH assays have used assay-defined proprietary calibrators derived from various sources with variably assigned values This causes variation of standard curves between AMH assays and has contributed to the observed variation of AMH measurement by immunoassays. For routine diagnostic laboratories, commutability requires validation across all assays and methods that use the reference material This ensures that patients’ results by routine measurement procedures, for example, AMH measured by automated or manual immunoassays, have equivalent values regardless of the AMH immunoassay used for the measurement. Commutability is, an essential requirement when a reference material is to be used as a common calibrator for clinical laboratory assays or in proficiency testing schemes or by commercial manufacturers as part of their internal traceability procedures to assign value to their product calibrators. Automated immunoassay platforms provide rapid testing for routine clinical practice
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