CA 19-9-CHECK-1 Quantitative determination of Cancer Antigen 19-9 (CA 19-9) in whole blood, plasma or serum samples

A group of mucin type glycoprotein Sialosyl Lewis Antigens (SLA) such as CA 19-9 and CA 15-3 has come to be recognized as circulating cancer associated antigens for gastrointestinal cancers. (1,2). Among these diseases, pancreatic cancer is one of the most lethal malignancies affecting mankind as, at the time of diagnosis, only 20% of patients are considered eligible for surgery with only one half having successful resection (3,4). It is therefore crucial to diagnose and/or detect the recurrence of pancreatic cancer at early stages. Recent studies demonstrate that serum CA 19-9 values may have utility in the management of pancreatic cancer treatment (5). However, CA 19-9 may be an imprecise or insufficient indicator as it could be elevated in many gastrointestinal cancers (colorectal, oesophageal and hepatocellular), cirrhosis and bile ducts diseases or absent in about 10% of the Caucasian population even in case of large tumors (6). The CA 19-9-CHECK-1 test is a rapid quantitative assay for the detection of CA 19-9 in serum, plasma or whole blood. The method employs a unique combination of monoclonal-dye conjugate and polyclonal solid phase antibodies to identify CA 19-9 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 19-9 forming an antibody-antigen complex. This complex binds to the anti- CA 19-9 antibody in the positive reaction zone (T) and produces a pink-rose colour band. In the absence of CA 19-9, 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 19-9 concentration level, different lines of different intensities will appear on the reading window allowing the quantitative measurement of CA 19-9 when used in combination with the VEDALAB’s rapid test readers.

Each kit contains

1. CA 19-9- CHECK-1reaction devices: 10 20
2. Disposable plastic pipettes: 10 20
3. Diluent in a dropper bottle: 2.5mL 5mL
4. Instruction leaflet: 1 1
5. Controls (Optional): Positive control (ref. V6900) and Negative control (ref. V6901): 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.