Description
INTENDED USE
The Calbiotech AFP ELISA Kit is intended for the quantitative measurement of AFP in human serum.
SUMMARY AND EXPLANATION
Alpha fetoprotein (AFP) is a glycoprotein with a molecular weight of approximately 70,000 Daltons. AFP is normally produced during fetal and neonatal development by the liver, yolksac, and in small concentrations by the gastrointestinal tract. After birth, serum AFP concentrations decrease rapidly, and by the second year of life and thereafter only trace amounts are normally detected in serum. Elevation of serum AFP to abnormally high values occurs in several malignant diseases, most notably nonseminomatous testicular cancer and primary hepatocellular carcinoma. In the case of nonseminomatous testicular cancer, a direct relationship has been observed between the incidence of elevated AFP levels and the stage of disease. Elevated AFP levels have also been observed in patients diagnosed with seminoma with nonseminomatous elements, but not in patients with pure seminoma.
In addition, elevated serum AFP concentrations have been measured in patients with other noncancerous diseases, including ataxia telangiectasia, hereditary tyrosinemia, neonatal hyperbilirubinemia, acute viral hepatitis, chronic active hepatitis, and cirrhosis. Elevated serum AFP concentrations are also observed in pregnant women. Therefore, AFP measurements are not recommended for use as a screening procedure to detect the presence of cancer in the general population.
PRINCIPLE OF THE TEST
The AFP is a direct solid phase sandwich ELISA method. The samples and diluted anti-AFP-HRP conjugate are added to the wells coated with MAb to beta subunit. AFP in the patient’s serum binds to anti-AFP MAb on the well and the anti-AFP second antibody then binds to AFP. Unbound protein and HRP conjugate are washed off by wash buffer. Upon the addition of the substrate, the intensity of color is proportional to the concentration of AFP in the samples. A standard curve is prepared relating color intensity to the concentration of the AFP.
