A new direct solid-phase radioimmunoassay for carcinoembryonic antigen without pretreatment of serum samples.

We examined some fundamental conditions for establishing a new simplified radioimmunoassay system for CEA. The system consists of antibody-coated plastic beads and radiolabeled tracer antibody. The reactivity of this system with several purified CEA preparations can vary due to differences in the nature of antibody preparations used either for coating beads or for tracer antibody. Among purified CEA preparations, we also found some differences in reactivity with a given immobilized antibody preparation. The assay system that resulted, referred to as bead-direct-RIA, needs neither pretreatment of serum samples nor centrifugation in any of its steps, and has a wide assay range, measuring CEA concentrations of 1-300 ng/ml using only 50 microliters of a serum sample. Its accuracy, reproducibility, dilution effect, and analytical recovery proved the reliability of this method. The mean value +/- S.D. for 48 normal adults was 2.5 +/- 1.0 ng/ml. It was found by comparative studies that the Z-gel method of Hoffmann-La Roche generally gave the highest values, the antibody-disc method of Dainabot gave the lowest, and the values by bead-direct-RIA fell between those of the 2 other methods and correlated well with either value. Follow-up studies on patients with malignancy indicated that the values by bead-direct-RIA fluctuated in parallel with those by Roche and Dainabot kits.