Additional Test Information

Testing performed using the Beckman Coulter Access BR Monitor assay. The concentration of CA 15-3 antigen in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods and reagent specificity. Values obtained with different assay methods cannot be used interchangeably. This device is indicated for use in the measurement of CA 15-3 antigen to aid in the management of breast cancer patients. Serial testing for CA 15-3 antigen concentrations should be used in conjunction with other clinical methods for monitoring breast cancer. Serum or plasma CA 15-3 antigen concentrations should not be interpreted as absolute evidence for the presence or absence of cancer. The Access BR Monitor Assay should not be used as a cancer screening test.