Establishment of a homogeneous immunoassay-light-initiated chemiluminescence assay for detecting anti-Müllerian hormone in human serum.

Abstract Anti-Mullerian hormone (AMH) is known as a reliable marker of ovarian reserve (OR). The determination of AMH is of great importance and most existed AMH detection methods are heterogeneous immunoassay. In this study, a novel homogeneous sandwich immunoassay-light-initiated chemiluminescence assay (LICA) for detecting AMH serum level was developed. This AMH-LICA was performed by incubating serum samples with AMH mouse monoclonal antibody coated with chemibeads, streptavidin-coated sensibeads, and biotinylated AMH mouse monoclonal antibody. Sensitivity, precision, accuracy and cross-reactivity of this assay were evaluated. Besides, a regression analysis showed a high correlation between AMH-LICA and Roche Elecsys® AMH assay (y = 0.9851x + 0.07147, R2 = 0.9569). As a homogeneous immunoassay, this AMH-LICA could accurately and rapidly determine the serum level of AMH with high-throughput. Thus, this new developed assay may be a new useful analytical tool for the determination of AMH.