CA 15-3-CHECK-1 Quantitative determination of Cancer Antigen 15-3 (CA 15-3) in whole blood, plasma or serum samples

Breast cancer is the most common life-threatening malignant lesion in women of many developed countries today (1). Around half of these newly diagnosed patients are node- negative, however 30% of these cases progress to metastatic disease. There are a number of tumor markers that can help to identify and diagnose which breast cancers will be an aggressive disease or which ones will have an indolent cause (2,3, 4). Among them, CA 15-3, which is an epitope of the protein antigen encoded by the breast cancer MUC1 gene, is the most frequently used marker in the management of invasive metastatic breast cancer (5). It correlates well with the extend of disseminated mammary carcinoma (6) and with therapeutic response to evaluate the disease progression or recurrence (7). The CA 15-3-CHECK-1 test is a rapid quantitative assay for the detection of CA 15-3 in serum, plasma or whole blood. The method employs a unique combination of monoclonal-dye conjugate and polyclonal solid phase antibodies to identify CA 15-3 in the test samples with a high degree of specificity. As the test sample flows through the absorbent device, the labelled antibody-dye conjugate binds to the CA 15-3 forming an antibody-antigen complex. This complex binds to the anti- CA 15-3 antibody in the positive reaction zone (T) and produces a pink-rose colour band. In the absence of CA 15-3, there is no line in the positive reaction zone (T). The reaction mixture continues flowing through the absorbent device past the reaction zone (T) and control zone (C). Depending on the CA 15-3 concentration level, different lines of different intensities will appear on the reading window allowing the quantitative measurement of CA 15-3 when used in combination with the VEDALAB’s rapid test readers.

Each kit contains

1. CA 15-3- CHECK-1 reaction devices: 10 20
2. Disposable plastic pipettes: 10 20
3. Diluent in a dropper bottle: 2.5 mL 5 mL
4. Instruction leaflet: 1 1
5. Controls (Optional): Positive control (ref. V6800) and Negative control (ref. V6801): a freeze-dried preparation of a non-infectious compound in diluted human serum, tested and found negative for anti-HIV, anti-HCV and HBs antigen, containing 0.05 % sodium azide is optionally available as a positive and negative control (1x 0.25 mL). The concentration range is indicated on the vial label.