Validation of the picoAMH assay on the Dynex DS2 platform

Abstract

Objectives: Anti-Müllerian hormone (AMH) is increasingly used as a biomarker of ovarian reserve in clinical practice, and is used both for management of fertility treatments and prediction of menopause. We sought to validate the newly FDA-approved Ansh Laboratories MenoCheck picoAMH ELISA on the Dynex-DS2 platform for clinical use in our obstetrics and gynecology center. Design: Validation of the picoAMH ELISA on the Dynex-DS2 was performed according to CLSI guidelines. Intra- and inter-assay CV, assay linearity, and method comparison studies were carried out to verify assay precision and accuracy. The manufacturer’s reference range was verified using 26 volunteer samples, and interference for hemolysis, lipemia, icterus, and biotin was evaluated. picoAMH results were additionally correlated with antral follicle count by ultrasound. Results: Intra- and inter-assay CV of the picoAMH assay on the DS2 was ≤4% and the assay was linear between concentrations of 0.0067–16.24 ng/mL (0.048–116.0 pmol/L) AMH. Method comparison was performed with the manufacturer’s laboratory and indicated good correlation, with Deming regression yielding slope of 0.928 and intercept of −0.0421. The assay displayed no significant interference from hemolysis (1000 mg/dL), lipemia (2000 mg/dL), conjugated bilirubin (66 mg/dL), or biotin (10,000 ng/mL). Measurement of AMH on the DS2 was also correlated with antral follicle count, with R = 0.7128. Conclusions: Our results indicate that the picoAMH ELISA on the DS2 has good analytical performance suitable for clinical use. Keywords: Anti-Müllerian hormone, Infertility, Method validation, Ovarian reserve