Alpha-fetoprotein is a glycoprotein present at very low concentrations under normal physiological conditions. AFP’s levels rise in pregnant women, as the liver of the developing fetus produces AFP and it appears in the mother’s blood. Screening during the second trimester of pregnancy is recommended, especially if the mother has a family history of birth defects, is 35 years or older, or has diabetes. Monitoring AFP levels in the mother’s blood can help indicate if there is a development issue with the neural tube that later becomes the brain and spinal cord. AFP is also associated with primary liver, stomach, lung, and other tumors, highlighting its value as a cancer marker.

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


  • Working range: 3.0-2000.0 ng/mL


Intra-lot Precision

  •  Intra-lot precision was determined by testing of AFP reference materials using 10 test devices from the same lot. CV ≤ 15%.

Inter-lot Precision

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


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


  • A serial concentration of AFP controls at 3.0-2000.0 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