Towards international standardization of immunoassays for Müllerian inhibiting substance/anti-Müllerian hormone. Issue 5 (November 2018)

• Record Type: Journal Article
• Authors: Ferguson, Jackie MC; Pépin, David; Duru, Chinwe; Matejtschuk, Paul; Donahoe, Patricia K; Burns, Chris J
• Is Part Of: Reproductive biomedicine online. Volume 37:Issue 5(2018)
• Page Start: 631
• Page End: 640
• Publication Date: 2018-11
• Subjects: Anti-Müllerian hormone -- Immunoassay -- International standard -- Müllerian inhibiting substance -- WHO -- World Health Organization; Human reproductive technology -- Periodicals; Human embryo -- Periodicals; Reproduction -- Periodicals; 616.692
• DOI: 10.1016/j.rbmo.2018.08.012
• Languages: English
• ISSNs: 1472-6483

Abstract

Abstract: Research question: Is formulated and lyophilized, recombinant human Müllerian inhibiting substance, also known as anti-Müllerian hormone (AMH), suitable for the preparation of a WHO international standard to calibrate AMH immunoassays? Design: The AMH content of a trial preparation, coded SS-581, was determined by five laboratories using seven immunoassay methods. Participants were requested to report the content of the preparation in terms of their method calibrators through the measurement of a minimum of five concentrations in the linear part of the dose-response curve. Participants were also asked to measure, concomitantly, a panel of six serum samples containing AMH at concentrations of 0.1–13.0 ng/ml. Results: Across all assays, including two automated assays in development, the geometric mean content was 361.76 ng/ampoule with a geometric coefficient of variation (GCV%) of 39.95%. When measured by immunoassays that were commercially available at the time of the study, the mean content was 423.08 ng/ampoule, with a GCV% of 26.67%. The inter-method geometric means of five serum samples with an AMH concentration >0.3 ng/ml and measured concomitantly with dilutions of SS-581 varied with a range of GCV% of 14.90–22.35%, which may reflect the use of serum sample value transfer to calibrate current immunoassays, some of which use non-human AMH calibrators. The AMH in trial preparation SS-581 was shown to be biologically active in the Müllerian duct regression assay. Conclusions: A reference material prepared using human recombinant AMH is a promising candidate for the preparation of an international standard for AMH for immunoassays calibrated to recombinant human AMH.