| Abstract: |
Multicenter evaluation the serum CA 15-3™ assay on the Bayer Immuno 1™ System demonstrated the analytical reliability of the immunoassay analyzer and the suitability of the automated CA 15-3 assay for the longitudinal monitoring of breast cancer patients. The procedure is a non-radioisotopic sandwich immunoassay, which utilizes Centocor licensed monoclonal antibodies DF3, and 115D8 to detect the MUC-1 gene-derived high molecular weight glycoprotein (breast cancer antigen). The Bayer Immuno 1 CA 15-3 assay was approved by the FDA for the detection of recurrence in previously diagnosed and treated Stage II and Stage III breast cancer patients. Evaluation of the automated CA 15-3 assay in our laboratory confirmed that the test exhibits excellent precision and compares favorably with the FDA approved Truquant® BR™ RIA procedure, a solid phase, competitive radioimmunoassay which measures the same mucin antigen (MUC-1). Clinical studies substantiate the reliability of the Bayer Immuno 1 CA 15-3 assay in detecting recurrence and in monitoring the clinical course of patients with metastatic breast cancer. |
