A multicentre evaluation of the new Beckman Coulter anti-Mullerian hormone immunoassay (AMH Gen II)

Background: The measurement of anti-Mullerian hormone (AMH) has been by two commercial enzyme-linked immunosorbent (ELISA) assays: Diagnostics Systems Laboratory (DSL 10-14400) and Immunotech (A11893 IVD EU only). Beckman Coulter has developed a new assay for AMH (AMH Gen II A79765), which uses the DSL antibodies but is standardized to the Immunotech calibration. As a result, comparative data are urgently required between the old DSL assay and its replacement AMH Gen II. Methods: An evaluation of the AMH Gen II assay was performed at three sites, each with extensive experience of measuring circulating AMH in the adult female. Results were compared with the original DSL ELISA assay. The analysis was performed on a total of 271 patients' samples, approximately 90 at each site. Results: Performance characteristics were evaluated for the AMHGen II assay. Linearity was acceptable with observed values close to the expected (mean recovery 106.3%). The functional sensitivity (20% coefficient of variation), calculated from precision profile data, was 1.5 pmol/L. Within- and between-batch imprecision, assessed over the concentration range of 570 pmol/L, were 5.3-11.4% and 3.8-17.3%, respectively. There was good agreement between assays with a Bablok-Passing regression equation AMH Gen II = 1.40 DSL-0.62 pmol/L, r = 0.96, n = 271. Conclusions: Our results demonstrate that similar precision and excellent between-assay agreement should be obtained when laboratories change from the DSL to the AMH Gen II ELISA and they should expect an increase in AMH values of approximately 40%.