Anti-Müllerian hormone testing: Evaluation of a novel method allowing more automation.

The anti-Müllerian hormone (AMH), a 140 kDa homodimeric glycoprotein of the transforming growth factor β (TGF-β) superfamily, is a useful serum biomarker of ovarian reserve. As an indicator, it mainly allows for the evaluation of primary ovarian insufficiency, the diagnosis of polycystic ovary syndrome (PCOS) and the prediction of the outcome of in vitro fertilization. Despite its increasing clinical importance, the methods for measuring AMH concentrations still require various manual steps. In this regard, our data showed that a novel fully-automated AMH immunoassay has excellent analytical performances, as well as a significant relationship with a well-established AMH enzyme linked immunosorbent assay (ELISA). The within- and between-run coefficients of variation (CV) of the new Elecsys(®) AMH immunoassay were ≤ 2.5%. The limit of detection of this automated assay was 0.01 ng/mL. While the correlation between the Elecsys(®) AMH method and the Ansh(®) Labs Ultrasensitive AMH/MIS ELISA was excellent (r = 0.97, p < 0.0001), a bias was nonetheless observed. An automated assay format for AMH can certainly be advantageous in reducing the analysis turnaround time and in consolidating assay. However, AMH assays are not standardized and interchangeable, as confirmed by our study, and a transition to routine therefore requires a careful evaluation and close communication with physicians.