• The CA 15-3 assay value, regardless of level, should not be interpreted as absolute evidence for the presence or absence of malignant disease. The CA 15-3 assay value should be used in conjunction with information available from clinical evaluation and diagnostic procedure.

• Methodology: immunochemiluminometric assay (ICMA) References Hayes DF, Zurawski VR Jr, and Kufe DW, "Comparison of Circulating CA 15-3 and Carcinoembryonic Antigen Levels in Patients With Breast Cancer, J Clin Oncol, 1986, 4(10):1542-50.