A Fully Automated Assay for Serum Antimüllerian Hormone Determination: Improvement of Analytical Performance Compared to Manual Assay

Background Antimüllerian hormone (AMH) is a glycoprotein hormone mainly studied for its regulatory role in male sex differentiation. In both sexes AMH is secreted in serum and represents a specific marker of spermatogenesis in men and ovarian reserve in women. In order to substitute our current assay to measure serum AMH with a new assay to make easier laboratory routine and providing more reproducible and accurate results, the evaluation of a fully automated CLIA assay was performed. Methods AMH Gen II ELISA assay is an enzymatically amplified two-site manual immunoassay and Access AMH assay is a highly automated CLIA. To compare methods, 154 serum samples covering the range of values clinically observable, were used. Data statistical analysis was performed. The Access AMH assay was also partially validated by linear dilution analysis, matrix effect analysis and LoQ determination. Results Compared methods showed good relationship with a slight constant and proportional but not significant systematic error, and very similar results were obtained at all analyzed concentrations. The new method showed good linearity over a wide range of dilutions, matrix effect was insignificant and the LoQ was set to 0.01 ng/mL, in line with manufacturer claim. Conclusions The fully automated Access AMH immunoassay represents a robust, fast and precise alternative to manual AMH assay with improvement in evaluation of serum AMH levels in terms of analytical performances.