SAT-016 Analytical Performance and Clinical Value of AMH Testing

The clinical uses for of anti-Mullerian hormone (AMH) measurements have risen dramatically over the past 5 years. This increase has been driven by the release of fully automated immunoassay systems with European and FDA approval of AMH measurements for assessing ovarian reserve in women presenting at fertility clinics. Most recently the MenoCheck® AMH method was cleared by FDA as an aid in determining menopausal status in women over the age of 40. Arguably much, of the increased use of AMH measurements is due more to greater test availability for infertility than to strong data supporting its clinical utility. Furthermore, few clinicians realize that the current methods for measuring AMH utilize antibodies with difference specificities, non-commutable calibrator materials, and significantly difference analytical performance characteristics. This presentation will summarize the analytical validation of MenoCheck® AMH methodology and results of the assessment of clinical value. This method is calibrated with recombinant human AMH in a non-covalent complex associated with the cleaved N-terminal portion of the AMH prohormone protein (the major circulating form of AMH) and demonstrates commutability with native human AMH. Validation studies conformed with published Clinical Laboratory Standards Institute guidelines. Values generated by the method were not commutable to other widely available methods based on method comparison studies using control materials or unadulterated serum from normally cycling women. Clinical value assessment was possible only because of a limit of quantitation enabling measurement of AMH in the majority of perimenopausal women. SWAN study specimens carefully annotated with relevant clinical information, including date of their final menstrual period, were available from women sampled and examined during their menopausal transition. The impact of method-specific differences among the various assay systems and their implications for intended clinical use of AMH testing will be discussed. Clinicians and translational investigators must consider these technical specifications when ordering and interpreting results from AMH testing.