Anti-Müllerian hormone (AMH) is a glycoprotein hormone produced by granulosa cells of small, growing follicles in the ovary. AMH serum concentrations decline over women’s reproductive lifespan, becoming undetectable approximately 5 years before menopause when the stock of primordial follicles is exhausted. Therefore, AMH has received increasing attention as a marker for ovarian reserves and has been shown to predict a woman’s reproductive potential.

AMH levels have become a useful fertility assessment tool that helps guide women’s fertility treatment and family planning decisions. AMH can also be used as a biomarker to diagnose polycystic ovary syndrome.

  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
  1. Range

Working range: 0.1-25.0 ng/mL

  1. Precision

Intra-lot Precision

Intra-lot precision was determined by testing of AMH reference materials using 10 test devices from the same lot. CV ≤ 10%.

Inter-lot Precision

Inter-lot precision was determined by testing of AMH reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.

  1. Accuracy

AMH control materials with two different concentrations were tested by every lot of test device, and the deviations were within ± 15%.

  1. Linearity

A serial concentration of AMH reference materials at 0.1-25.0 ng/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.

Reagents and Materials provided:

  1. Individually sealed foil pouches containing:
    1. One test device
    2. One desiccant
  2. Detection buffer tubes
  3. SD card
  4. Instructions for Use


Materials required but not provided:

  1. Clock or timer
  2. RaFIA Immunofluorescence Analyzer
  3. RaFIA Immunofluorescence Incubator