The CA15-3 Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the semi-quantitative detection of CA15-3 in whole blood, serum or plasma as aid in monitoring response to breast cancer treatment and disease recurrence.
Cancer antigen 15-3(CA15-3) is a mucinous carbohydrate antigen product of the MUC1 gene, originally identified by two monoclonal antibodies: DF3 raised against metastatic breast cancer cells and 115D8 raised against human milk fat globule membrane.1,2 It is found on the surface of many types of cancer cells and shed into the blood stream. CA15-3 is a tumor marker used to monitor certain cancers, especially breast cancer. It is most useful for monitoring patients post-operatively for recurrence, particularly metastatic diseases.3,4 96% of patients with local and systemic recurrence have elevated CA15-3, which can be used to predict recurrence earlier than radiological and clinical criteria.50% decrease in serum CA15-3 is associated with response to treatment. CA15-3 is more sensitive than CEA in early detection of breast cancer recurrence. CA15-3, although preferentially associated with breast cancer, is not tissue specific, and only about 10% of women with early localized breast cancer have elevated CA15-3. Besides, CA15-3 may also be elevated in a variety of conditions, including cancer of the lung, pancreas, ovary, prostate, and colon as well as cirrhosis, hepatitis, and benign breast disorders and in a certain percentage of apparently healthy individuals.5 The CA15-3 Rapid Test Cassette (Whole Blood/Serum/Plasma) utilizes a combination of colloidal gold conjugare and anti-CA15-3 antibodies to selectively detect total CA15-3 in whole blood, serum or plasma. The test has a cut-off value or a reference value of 30 U/ml. The reference range of CA 15-3 is less than 30 IU/ml.
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