A-055 Clinical Performance Evaluation of the ADVIA Centaur AMH Assay

Abstract

Abstract Background Anti-Müllerian hormone (AMH) is a transforming growth factor beta protein synthesized by granulosa cells of small growing follicles in ovaries in females and by Sertoli cells of the testes in males. AMH measurements are increasingly being used in the assessment of ovarian reserve, prediction of response to controlled ovarian stimulation in women undergoing assisted reproductive technologies, as an aid in the diagnostic evaluation of polycystic ovary syndrome, and prediction of menopause. The objective of this study was to evaluate the clinical performance of the ADVIA Centaur® AMH assay in the assessment of ovarian reserve and compare performance to the Beckman ACCESS 2 AMH assay. In addition, an exploratory analysis evaluated ADVIA Centaur AMH assay performance in distinguishing women with expected poor ovarian response per published criteria. Methods Clinical specimens were collected from 577 women at 11 U.S. fertility centers. Women enrolled were 22–45 years old and possessed both ovaries. They underwent blood draw and transvaginal ultrasound to measure the antral follicle count on days 2–4 of menstrual cycle. Women with BMI ≥40; pregnancy within 3 months; on contraceptives, hormonal medications; undergoing treatment for malignancy, ovarian abnormalities, surgery in the past 6 months; or with endocrine or metabolic disorders (including PCOS) were excluded. Results Results were considered positive (high ovarian reserve) if the AMH concentration was >1.77 ng/mL and AFC was >15 and negative (normal-to-diminished ovarian reserve) if the AMH concentration was ≤1.77 ng/mL and AFC was ≤15. The estimated sensitivity, specificity, and two-sided 95% Wilson score confidence intervals (CI) of each parameter were determined to be 90.76% (86.97–93.53) and 52.19% (46.29–58.03) using the ADVIA Centaur AMH assay, and 90.10% (86.22–92.98) and 52.19% (46.29–58.03) with the ACCESS 2 AMH assay, respectively.A secondary analysis was completed to investigate poor ovarian response (POR) according to the Bologna criteria, published by the ESHRE. These criteria define poor ovarian response as an AMH measurement of less than 1.1 ng/mL and AFC of less than 7. Of the 577 women included in the study, 32 women had an antral follicle count less than 7, of whom 26 also had a AMH concentration of less than 1.1 ng/mL. Of the 545 women with an antral follicle count greater than or equal to 7, 480 also had AMH measurements of greater than or equal to 1.1 ng/mL. Using the Bologna criteria, the ADVIA Centaur AMH assay performs with a sensitivity of 81.25% and specificity of 88.07%. Conclusions In this clinical population, the sensitivity and specificity of AMH assays on the ADVIA Centaur XP and Beckman ACCESS 2 systems were almost identical when using an AMH cutoff ≤1.77 ng/mL and AFC ≤15 to identify normal-to-diminished ovarian reserve. Using published criteria for POR resulted in a sensitivity and specificity of 81.25% and 88.07% for the ADVIA Centaur AMH assay. Not available for sale in the U.S. Future availability cannot be guaranteed. Product availability varies by county. HOOD#05162003331923