[Fundamental and clinical evaluation of an immunoradiometric assay procedure "Amerwell AFP" for estimation of serum alpha-fetoprotein].

The efficacy of assay procedure for estimation of serum alpha-fetoprotein (AFP) was examined on "Amerwell AFP" immunoradiometric assay (IRMA) using monoclonal AFP antibody. The condition of incubation was most satisfactory for 2 hours at 37 degrees C. Coefficients of variance for intraassay and interassay were 5.1-10.0% and 8.4-9.9% respectively. Dilution test gave satisfactory results. The binding capacity of microplate-well tagged monoclonal AFP antibody with AFP antigen was satisfactory for assay reactions. This method showed a good correlation to the AFP RIA bead (Dinabot Co.) method. The normal range (reference value) was within the level of 5.0 IU/ml due to Hoffmann's method in the examination of 860 subjects. Estimation of AFP with "Amerwell AFP" IRMA kit was a feasible routine method of clinical application for tumor marker.