The Autobio cancer antigen 15-3 (CA15-3) chemiluminescence immunoassay (CLIA) kit is intended for the quantitative determination of CA15-3 concentration in human serum.
Breast cancer is the most common life-threatening malignant lesion in women of many developed countries today, with approximately 180,000 new cases diagnosed every year. Roughly half of these newly diagnosed patients are node-negative, however 30% of these cases progress to metastatic disease.
Research studies have indicated that CA 15-3 assay values are frequently elevated in patients with breast cancer. These studies have suggested that the CA 15-3 assay may be of clinical value for monitoring the response of patients undergoing therapy because increasing and decreasing values correlated with disease progression and regression, respectively. Additional published studies have suggested that increasing CA 15-3 assay values in patients at risk for breast cancer recurrence after primary therapy may be indicative of recurrent disease before it can be detected clinically. Elevations of CA 15-3 assay values have been reported in individuals with nonmalignant conditions such as cirrhosis, hepatitis, autoimmune disorders, and benign diseases of the ovary and breast. Non-mammary malignancies in which elevated CA 15-3 assay values have been reported include lung, colon, pancreatic, primary liver, ovarian, cervical, and endometrial. CA 15-3 assay values are not elevated in most normal individuals.
The CA 15-3 assay is not recommended as a screening procedure to detect cancer in the general population; however, use of the CA 15-3 assay as an aid in the management of breast cancer patients has been reported.
