Abstract
ObjectivesAnti-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. DesignValidation 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. ResultsIntra- 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. ConclusionsOur results indicate that the picoAMH ELISA on the DS2 has good analytical performance suitable for clinical use.
Highlights
Anti-Müllerian hormone (AMH) is a homodimeric glycoprotein with roles in regulation of fetal sexual differentiation and folliculogenesis in the adult ovary
The most common method of measurement used for AMH is enzyme-linked immunosorbent assay (ELISA), earlier ELISA assays have suffered from problems with sample stability [3] and measurement variability [4]
We describe the validation and characterization of the FDA-approved MenoCheck picoAMH ELISA from Ansh Laboratories using the Dynex-DS2 automated immunoassay system, and evaluate its utility for monitoring of ovarian reserve in a reproductive endocrinology and infertility/in vitro fertilization (REI/IVF) setting
Summary
Anti-Müllerian hormone (AMH) is a homodimeric glycoprotein with roles in regulation of fetal sexual differentiation and folliculogenesis in the adult ovary. AMH production is restricted to granulosa cells in growing ovarian follicles and is thought to be a regulator of dominant follicle selection [1]. Contemporary clinical interest in AMH is primarily in its utility as a marker for ovarian reserve, with an increasing number of laboratories offering measurement of AMH for prediction of response to controlled ovarian stimulation in assisted reproductive therapy [2]. Newer-generation assays have equivalent performance with fewer reproducibility issues [5,6]. A picoAMH assay with a lower detection threshold from Ansh Laboratories was first
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