KFDA Registration No :   14-3049
   CAT No :   DEC01
   SAMPLE VOLUME :   50 ul
   INCUBATION TIME :   30'+30'+10'RT
   STD RANGE :   0-200 ng/ml

Intended Use

Enzyme immunometric assay for quantitative determination of alpha-fetoprotein (AFP) in human serum or plasma


Alpha-Fetoprotein (AFP) is a glycoprotein of about 65.000 daltons molecular weight synthesized by the parenchymal cells of the fetal liver and the yolk sac. The properties and amino acid composition are similar to those of albumin. Synthesis of AFP occurs primarily in the liver and yolk sac of the fetus. The AFP level increases progressively as pregnancy progresses and reaches a peak at about the 14th week in the fetal serum and the 30th week in the maternal serum; it then progressively decreases. Elevated serum AFP levels subsequently reappear during pregnancy and in conjunction with several malignant diseases.

Principle of the Assay

The DIAKEY AFP ELISA is a non-competitive immunoassay. During the reaction, sample and AFP of each concentration attached to the conjugate combine competitively inside the plate where dispensed AFP monoclonal antibody is attached. After the reaction, the materials which have not been combined are removed and the amount of complex attached to the solid phase is inversely proportional to the amount of AFP inside the sample. The result is calculated by reading absorbance using spectrophotometer.

Handling Precaution

  • Do not use mixed reagents from different lots.
  • Do not use reagents beyond the expiration date.
  • Use distilled water stored in clean container.
  • Use an individual disposable tip for each sample and reagent, to prevent the possible cross-contamination among the samples.
  • Rapidly dispense reagents during the assay, not to let wells dry out.

Use Precaution

  • Wear disposable globes while handling the kit reagents and wash hands thoroughly afterwards.
  • Do not pipette by mouth.
  • Do not smoke, eat or drink in areas where specimens or kit reagents are handle.
  • Handle samples, reagents and loboratory equipments used for assy with extreme care, as they may potentially contain infectious agents.
  • When samples or reagents happen to be spilt, wash carefully with a 1% sodium hypochlorite solution.
  • Dispose of this cleaning liquid and also such used washing cloth or tissue paper with care, as they may also contain infectious agents.
  • Avoid microbial contamination when the reagent vial be eventually opend or the contents be handled.
  • Use only for IN VITRO.