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The Centocor CA 15-3 RIA is an in vitro test for the quantitative determination of DF3 antibodydefined antigen, encoded by the MUC 1 gene, in serum and plasma, Serial test results obtained with the Centocor CA 15-3 RIA, are useful in the early detection of recurrence in patients previously treated for stage III breast cancer, who are clinically free of disease. Early detection of recurrence cannot be readily accomplished by routine clinical or diagnostic studies alone. The use of a circulating serum tumor marker assay, such as Centocor CA 15-3 RIA, can be useful in the identification of these patients. The Centocor CA 15-3 RIA should be used in conjunction with all relevant information derived from diagnostic tests, physical examination and full medical history, in accordance with appropriate patient management procedures

The Centocor CA 15-3 RIA is an in vitro diagnostic device based on the well established RIA "forward sandwich" principle. The device is in kit format and consists of murine monoclonal antibody 115D8-coated polystyrene beads, standards, diluent, positive control, and 122 radio-labeled, murine monoclonal antibody, DF3. Antibody coated beads are incubated with a specimen or the appropriate standards and controls. During this initial incubation step, DF3 antibody-defined antigen present in the specimen are bound by the coated beads. Unbound material present in the specimen are removed by aspiration and washing. In the second step, the beads are incubated with DF3 radio-labeled with "2". The tracer detects DF3 antibody-defined antigen bound to the beads during the initial incubation step. The unbound tracer antibody is removed by washing and aspiration. The bound radioactivity is determined by counting the beads in a gamma counter. The bound radioactivity is directly proportional to the concentration of the DF3 antibody-defined antigen in the specimen. A standard curve is obtained by plotting the DF3 antibody-defined antigen concentration of the standards against the bound radioactivity.