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Anti-Müllerian Hormone Immunoassay Validated

By LabMedica International staff writers
Posted on 04 Nov 2019
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Image: The MenoCheck picoAMH ELISA is FDA cleared for in vitro diagnostic use as an aid in the determination of menopausal status in women between 42 and 62 years of age (Photo courtesy of Ansh Laboratories).
Image: The MenoCheck picoAMH ELISA is FDA cleared for in vitro diagnostic use as an aid in the determination of menopausal status in women between 42 and 62 years of age (Photo courtesy of Ansh Laboratories).
Anti-Müllerian hormone (AMH) is a homodimeric glycoprotein with roles in regulation of fetal sexual differentiation and folliculogenesis in the adult ovary. 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.

The most common method of measurement used for AMH is enzyme-linked immunosorbent assay (ELISA), although earlier ELISA assays have suffered from problems with sample stability and measurement variability. Newer-generation assays have equivalent performance with fewer reproducibility issues.

A team of scientists from Baylor College of Medicine (Houston, TX, USA) collected 28 serum samples were collected from patients for whom AMH testing was requested and were measured by two assays. A subset of the specimens used in accuracy studies was used to perform correlation of AMH measurements with antral follicle count (AFC). Reference ranges given by the manufacturer were verified using samples from 26 healthy female volunteers aged 22–41 years with samples tested as previously described.

The team sought to validate the newly FDA-approved MenoCheck picoAMH ELISA (Ansh Laboratories, Webster, TX, USA) on the Dynex-DS2 platform (Dynex Technologies, Chantilly, VA, USA) for clinical use in their obstetrics and gynecology center. Accuracy of the picoAMH ELISA on the Dynex-DS2 was determined by comparison with ELISA performed onsite at the Ansh Laboratories’ CLIA-certified laboratory.

The investigators reported that 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. The assay displayed no significant interference from hemolysis (1,000 mg/dL), lipemia (2,000 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.

The authors concluded that their results indicate that the picoAMH ELISA on the DS2 has good analytical performance suitable for clinical use and that it can be used for patient testing in the reproductive endocrinology and infertility/in vitro fertilization (REI/IVF) setting in their hospital. The study was published in the November 2019 issue of the journal Practical Laboratory Medicine.

Related Links:
Baylor College of Medicine
Ansh Laboratories
Dynex Technologies

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