Towards international standardization of immunoassays for Müllerian inhibiting substance/anti-Müllerian hormone

Reproductive Biomedicine Online
Jackie Mc FergusonChris Burns

Abstract

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? 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. 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...Continue Reading

Citations

Sep 22, 2018·The Journal of Clinical Endocrinology and Metabolism·Jennifer Y HsuMary E Sabatini
Nov 23, 2019·Journal of Assisted Reproduction and Genetics·Jure BedenkIrma Virant-Klun
Aug 18, 2020·Reproductive Biology and Endocrinology : RB&E·Jackie FergusonChris Burns
Oct 17, 2020·Reproductive Biomedicine Online·Horace RomanLucian Puscasiu
May 17, 2021·Reproductive Biology and Endocrinology : RB&E·Haroon Latif KhanEnder Yalcinkaya Kalyan
Jun 11, 2021·Frontiers in Endocrinology·Hang Wun Raymond LiWilliam Leigh Ledger
Jul 27, 2021·PloS One·Eman Ahmed El-AttarAhmed Salah El-Din Tork

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BETA
ELISA
glycosylation

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Excel
GraphPad
CombiStats
GraphPad Prism
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