A-037 Statistical Evaluation of the ADVIA Centaur Anti-Müllerian Hormone Serological Assay for Predicting Poor Ovarian Response

Abstract Background Serum Anti-Müllerian Hormone (AMH) levels and antral follicle count are key in evaluating ovarian reserve (OR) for fertility. Additionally, serum AMH measurements are increasingly being utilized to predict the response to controlled ovarian stimulation in women undergoing assisted reproductive technologies. Previous studies demonstrated that the ADVIA Centaur XP AMH assay has clinical performance equivalent to Beckman Access 2 AMH assay when used for OR assessment, distinguishing diminished/normal and high OR using 1.77 ng/ml cutoff. A secondary statistical analysis was conducted to evaluate the ADVIA Centaur AMH assay performance in identifying women with expected poor ovarian response based on established published criteria Methods A method comparison analysis between the ADVIA Centaur AMH and Beckman Access 2 AMH assay was performed using 533 samples collected from women presenting to fertility clinics for OR assessment. Following CLSI EP12-A2 guidelines, the diagnostic concordance (negative (NPA) and positive (PPA) agreement) between ADVIA Centaur XP AMH and Beckman Access 2 AMH assays was estimated using the Beckman validated cutoff of 0.93 ng/mL for predicting poor ovarian response to controlled ovarian stimulation, defined as <=4 oocytes retrieved following stimulation. Results Data analysis resulted in strong agreement between methods with a PPA of 99.15% (95% Confidence Interval, 97.84-99.67) based on 471 samples with Beckman AMH results >0.93 ng/mL, and a NPA of 95.16% (95% CI, 86.71-98.34) based on 62 samples with Beckman AMH results <=0.93 ng/mL. Conclusion Using published criteria for poor ovarian response, our statistical analysis suggests that Centaur AMH assay has equivalent performance to the Beckman AMH assay in predicting poor ovarian response to controlled ovarian stimulation. For educational and scientific exchange only. This assay is not intended to be used as an aid in the prediction of poor ovarian response in U.S.