A group of mucin type glycoprotein Sialosyl Lewis Antigens (SLA), such as CA19-9 and CA19-5, have come to be recognized as circulating cancer associated antigens for gastrointestinal cancer. CA19-9 represents the most important and basic carbohydrate tumor marker. The immunohistologic distribution of CA19-9 in tissues is consistent with the quantitative determination of higher CA19-9 concentrations in cancer than in normal or inflamed tissues. Recent reports indicate that the serum CA19-9 level is frequently elevated in the serum of subjects with various gastrointestinal malignancies, such as pancreatic, colorectal, gastric and hepatic carcinomas. Together with CEA, elevated CA19-9 is suggestive of gallbladder neoplasm in the setting of inflammatory gallbladder disease. This tumor-associated antigen may also be elevated in some non-malignant conditions. Research studies demonstrate that serum CA19-9 values may have utility in monitoring subjects with the above-mentioned diagnosed malignancies. It has been shown that a persistent elevation in serum CA19-9 value following treatment may be indicative of occult metastatic and/or residual disease. A persistently rising serum CA19-9 value may be associated with progressive malignant disease and poor therapeutic response. A declining CA19-9 value may be indicative of a favorable prognosis and good response to treatment.
Intended Use
The CA19-9 assay kit is intended to be used as a monitoring and screening test. An abnormal result (i.e. an elevated serum CA19-9) suggests the need for further clinical management. This test has been found useful for patients in clinical remission, as post-operative serum CA19-9 values which fail to return to normal strongly suggest the presence of residual tumor and tumor recurrence is often accompanied by a rise of serum levels before progressive disease is clinically evident.
Test Principle
The CA19-9 EIA test is a solid phase two-site immunoassay. One monoclonal antibody is coated on the surface of the microtiter wells and another monoclonal antibody labeled with horseradish peroxidase is used as the tracer. The CA19-9 molecules present in the standard solution or serum are "sandwiched" between the two antibodies. Following the formation of the coated antibody-antigen-antibody-enzyme complex, the unbound antibody- enzyme labels are removed by washing. The horseradish peroxidase activity bound in the wells is then assayed by colorimetric reactions. The intensity of the color formed is proportional to the concentration of CA19-9 present in the sample.
Detection Range: 0-240Units/ml
Kit Components: |Microtiter Plate, 1x96wells|Assay Buffer, 1x12ml|Enzyme Conjugate Reagent, 1x12ml|Standard, 0units/ml, 1x1vial|Standard, 15units/ml, 1x1vial|Standard, 30units/ml, 1x1vial|Standard, 60units/ml, 1x1vial|Standard, 120units/ml, 1x1vial|Standard, 240units/ml, 1x1vial|TMB Substrate, 1x12ml|Stop Solution, 1x12ml|Wash Buffer (50X), 1x15ml
Storage and Stability
Store all components at 4°C. Stable for 6 months. For maximum recovery of product, centrifuge the original vial prior to removing the cap.
References
1.Glenn, J., Steinberg, W.M., Kurtzman, S.H., et at. Evaluation of the utility of a radioimmunoassay for serum CA 19-9 level in patients before and after treatment of carcinoma of the pancreas. J. Clin. Oncol. 1988; 6:462-8. 2. Hayakawa, T., Kondo, T., Shibata, T. et al. Sensitive serum markers for detecting pancreatic cancer. Cancer 1988; 61:1827-31. 3. Koprowski, H., Herly, M., Steplewski, Z., et al. Specific antigen in serum of patients with colon carcinoma. Science 1981; 212:53-5. 4. Malesci, A., Tommasini, M.A., Bonato, C. et al. Determination of CA19-9 antigen in serum and pancreatic juice for differential diagnosis of pancreatic adenocarcinoma from chronic pancreatitis. Gastroenteroglogy 1987; 92:60-7. 5. Safi, F, Roscher, R., Bittner, R., et al. High sensitivity and specificity of CA 19-9 for pancreatic carcinoma in comparison to chronic pancreatitis. Serological and immunohistochemical findings. Pancreas 1987; 2:398- 403. 6.Steinberg, W. The clinical utility of CA 19-9 tumor associated antigen. American J. of Gastroenterology 1990; 85:350-355. 7.Steinberg, W.M., Gelfand, R., Anderson, K.K., et al. Comparison of the sensitivity and specificity of the CA 19-9 and carcinoembryonic antigen assays in detecting cancer of the pancreas. Gastroenterology 1986; 90:343-9. 8. Takasaki, H., Uchida, E., Tempero, M.A., et al. Correlative study on expression of CA 19-9 and DU-Pan-2 in tumor tissue and in serum of pancreatic cancer patients. Cancer Res. 1988; 48:1435-8. 9. Tatsuta, M., Yamamura, H., Iishi H., et al. Values of CA19-9 in the serum, pure pancreatic juice and aspirated pancreatic material in the diagnosis of malignant pancreatic tumor. Cancer 1985; 56:2669-73. 10. Wang, T.H. Lin, J.W., Chen, D.S., et al. Noninvasive diagnosis of advanced panceatic cancer by real-time ultrasonography, carcinoembryonic antigen, and carbohydrate antigen 19-9. Pancreas 1986; 1:219-23. 11. Strom BL, Maislin G, West SL, et al. Serum CEA and CA19-9: potential future diagnostic or screening tests for gallbladder cancer? Int. J. Cancer 1990; 45:821
