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TM-CA 19-9

The TM-CA 19-9 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of CA 19-9 in serum or plasma (EDTA or heparin plasma)


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Product Catalog No: EIA-5069 Pack Size: 96 Wells

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Summary

The sialyl Lewisa epitope is also known as the cancer associated antigen CA 19-9. CA 19-9 levels are frequently elevated in the serum of patients with cancers of the pancreato-biliary system (i.e. pancreas, gallbladder, biliary tract). In addition, elevated levels of CA 19-9 have been observed in other malignancies such as lung cancer, other gastrointestinal cancers and in some nonmalignant disorders. It must be taken into acount that patients, genotypically negative for the Lewis blood group antigen, will be unable to produce the CA 19-9 antigen even in the presence of malignant tissue.

Test Principle

The TM-CA 19-9 ELISA Kit is a solid phase enzyme-linked immunosorbent assay (ELISA) based on the sandwich principle. The microtiter wells are coated with a monoclonal [mouse] antibody directed towards a unique antigenic site of the CA 19-9 molecule. An aliquot of patient sample containing endogenous CA 19-9 is incubated in the coated well with assay buffer. After a washing step a second incubation follows with enzyme conjugate, which is an anti-CA 19-9 antibody conjugated with horseradish peroxidase. After incubation the unbound conjugate is washed off. The amount of bound peroxidase is proportional to the concentration of CA 19-9 in the sample. Having added the substrate solution, the intensity of colour developed is proportional to the concentration of CA 19-9 in the patient sample.

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References
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  • NCCLS Guideline EP5-A, entitled “Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline,” February 1999.
  • Del Villano B and Zurawski V Jr: The carbohydrate antigenic determinant 19-9 (CA 19-9): a monoclonal antibody defined tumor marker. Immunodiagnostics – Laboratory and Research Methods in Biology and Medicine, Volume 8. Ed. By J. Hyun and R. Aloisi, Alan R. Liss, New York, pp. 269-282, 1983.
  • Dietel M, Arps H, Müller-Hagen S, Sieck M and Hoffmann L: Antigen detection by the monoclonal antibodies CA 19-9 and CA 125 in normal and tumor tissue and patients´ sera – J Cancer Research Clinical Oncology 111:257-265, 1986
  • Fritz S, Hackert T, Hinz U, Hartwig W, Büchler MW, Werner J.: Role of serum carbohydrate antigen 19-9 and carcinoembryonic antigen in distinguishing between benign and invasive intraductal papillary mucinous neoplasm of the pancreas. Br J Surg. 98(1):104-10, 2011.
  • Bedi MM, Gandhi MD, Jacob G, Lekha V, Venugopal A, Ramesh H: CA 19-9 to differentiate benign and malignant masses in chronic pancreatitis: is there any benefit? Indian J Gastroenterol 28(1):24-7, 2009.
  • Morris-Stiff G, Teli M, Jardine N, Puntis MC: CA19-9 antigen levels can distinguish between benign and malignant pancreaticobiliary disease. Hepatobiliary Pancreat Dis Int 8(6):620-6, 2008.
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