WHO/BS/2019.2363 WHO IS for Mullerian Inhibiting Substance/Anti-Mullerian Hormone, human, recombinant

Overview

The World Health Organization (WHO) Expert Committee on Biological Standardization (ECBS) has recognized (2015)(1) the need for an International Standard (IS) for Mullerian Inhibiting Substance/Anti-Mullerian Hormone (AMH), used for the calibration of immunoassays to measure AMH in human serum and plasma. We report here, the evaluation of a candidate standard for AMH, human, recombinant, coded 16/190, by immunoassay in an international collaborative study carried out by seven laboratories in four countries.

The geometric mean of all laboratory estimates from valid assays for the AMH content of the candidate standard was 511 ng/amp (95% CI: 426 - 612, n=16, GCV 42%) with a robust geometric mean of 489 ng/amp. It is noted that these estimates are based on individual method calibrations. Measurement of a coded duplicate confirmed low intra-assay variability for each method, with the ratio of estimates for coded duplicates ranging from 0.91 to 1.08 in 30/32 valid assay runs. Measurement of a comparator sample (ampoule B) with a lower AMH content suggested that recognition of AMH was consistent within a method. Estimates of the AMH content of ampoule B relative to the candidate IS ranged from 0.41 to 0.65 in individual assays with an overall study geometric mean of 0.53 (95%CI: 0.50 – 0.56; GCV% 12%; n=16). Measurement of thermally accelerated degradation samples has demonstrated that the candidate is sufficiently stable to serve as an IS.