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TRUQUANT® BR™ RIA is an in vitro diagnostic device indicated for the quantitative determination of CA 27.29 antigen in serum or EDTA plasma of patients previously treated for stage II or stage III breast cancer. Serial testing for CA 27.29 antigen with TRUQUANT® BR™ RIA in patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of recurrence. In addition, quantitation of CA 27.29 antigen in conjunction with other clinical methods can be used as an aid in monitoring response to therapy in patients with stage IV breast cancer.

TRUQUANT® BR™ RIA quantitates CA 27.29 by competitive inhibition RIA. 125(iodine-labelled monoclonal antibody, specific for CA 27.29, is added to antigen-coated polystyrene tubes with the specimen in the form of plasma or serum. Antigen (CA 27.29) in the specimen inhibits the antibody from binding to the CA 27.29 antigen on the tube and after a subsequent wash step, bound radioactivity is determined. A calibration curve, generated from standards containing known quantities of CA 27.29, is used to determine the amount of antigen in the specimen.