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Elecsys® Carcinoembryonic antigen (CEA) Electro-chemiluminescence immunoassay (ECLIA) for the quantitative determination of CEA in human serum and plasma Indication CEA is a monomeric glycoprotein with a molecular weight of approx. 18 kD.1 It belongs to the group of carcinofetal antigens that are produced during the embryonic and fetal period.2 The formation of CEA is repressed after birth, and it is hardly measurable in healthy adults. High CEA concentrations are frequently found in cases of colorectal adenocarcinoma3 and the main indication for CEA determinations is the follow-up and therapy-management of colorectal carcinoma patients. Combined with other markers CEA also has the potential to aid in the early detection of colorectal cancer.4,5 Elevated levels of CEA have been also described in advanced breast cancer, pancreatic cancer, lung cancer and other non-colonic adenocarcinomas.6 According to the recommendations of the American Society of Clinical Oncology (ASCO) CEA can be used in the following way: 7,8 Colorectal cancer: •CEA levels should be measured preoperatively as it can assist in staging and surgical treatment planning. •CEA levels should be monitored after primary surgery every 3 months for at least 2 years if the possibility of a second intervention is clinically indicated. •CEA is the marker of choice for monitoring metastatic colorectal cancer during systemic therapy and should be measured at the start of treatment for metastatic disease and every 1- 3 months during active treatment. Breast cancer: •CEA can be used for monitoring patients with metastatic disease during active therapy and can be used in conjunction with diagnostic imaging, history, and physical examination. •An increasing CEA may be used to indicate treatment failure. Slight to moderate CEA elevations (rarely > 10 ng/mL) occur in 20 - 50 % of benign diseases of the intestine, the pancreas, the liver, and the lungs.9 Also smokers have elevated CEA values.10 Test principle: one-step sandwich assay CEA in the sample Ru Biotinylated chimeric human/ mouse antibody against human CEA Ruthenylated monoclonal antibody against human CEA Streptavidin microparticle 9 min 9 min Ru Measurement Ru The reactive epitopes of CEA have been characterized.11 A chimeric antibody and special interference eliminating reagents are integrated into the Elecsys CEA assay to reduce interferences from Human-Anti-Mouse-Antibodies (HAMA) for enhanced assay robustness.12 This is important as interferences from HAMA can generate false positive or false negative results. Elecsys technology ECL (ElectroChemiLuminescence) is Roche’s technology for immunoassay detection. Based on this technology and combined with well-designed, specific and sensitive immunoassays, Elecsys delivers reliable results. The development of ECL immunoassays is based on the use of a ruthenium-complex and tripropylamine (TPA). The chemiluminescence reaction for the detection of the reaction complex is initiated by applying a voltage to the sample solution resulting in a precisely controlled reaction. ECL technology can accommodate many immunoassay principles while providing superior performance. Elecsys® CEA assay characteristics: Testing time Test principle Traceability Sample material Sample volume Detection limit Measuring range (low end defined by lower detection limit) Repeatability Intermediate imprecision Expected values Order information: Material Elecsys® CEA Elecsys® CEA CalSet PreciControl Tumormarker or PreciControl Universal Diluent Universal 18 min One-step sandwich assay IRP WHO Reference Standard 73/601 Serum, Li-heparin, Na-heparin, K3-EDTA and sodium citrate plasma. When sodium citrate is used, the results must be corrected by + 10 % 10 μL 0.20 ng/mL 0.20 - 1000 ng/mL cobas e 601 / e 602 modules, E 170: 1.0 - 2.5 % 1.3 - 5.0 % Elecsys® 2010 and cobas e 411 analyzer: cobas e 601 / e 602 modules, E 170: 4.6 - 5.1 % 2.0 - 5.4 % Elecsys® 2010 and cobas e 411 analyzer: 20 - 69 years (for 95 % of the results) - non-smokers: 3.8 ng/mL - smokers: 5.5 ng/mL Product configuration 100 tests 200 tests 4 x 1 mL 2 x 3 mL each 2 x 16 mL sample diluent or 2 x 36 mL sample diluent References: 1 Gold, P., Freedman, S.O. (1965). Demonstration of tumor-specific antigen in human colonic carcinomata. J. Exp. Med.; 121, 439. 2 Thompson, J.A. (1995). Molecular cloning and expression of carcinoembryonic antigen gene family members. Tumor Biol.; 16, 10-16. 3 Ballesta, A.M., Molina, R., Filella, X., Jo, J., Gimenez, N. (1995). Carcinoembryonic Antigen in Staging and Follow-up of Patients with Solid Tumors. Tumor Biol.; 16, 32-41. 4 Nielsen, H.J., Brunner, N., Jorgensen, L.N., Olsen, J., Rahr, H.B., Thygesen, K., Hoyer, U., Laurberg, S., Stieber, P., Blankenstein, M.A., Davis, G., Dowell, B.L., Christensen, I.J. (2011). Plasma TIMP-1 and CEA in detection of primary colorectal cancer: a prospective, population based study of 4509 high-risk individuals. Scand. J. Gastroenterol.; 46, 60-69. Not for distribution in the USA. COBAS, COBAS E, LIFE NEEDS ANSWERS and ELECSYS are trademarks of Roche. ©2011 Roche Roche Diagnostics Ltd. CH-6343 Rotkreuz Switzerland www.cobas.com Material number 11731629 322 04491777 190 11731645 322 11776452 122 or 11731416 122 11732277 122 or 03183971 122 5 Wild, N., Herbert, A., Rollinger, W., Krause, F., Dilba, P., Tacke, M., Karl, J. (2010). A Combination of Serum Markers for the Early Detection of Colorectal Cancer. Clin. Cancer Res.; 16, 6111-6121. 6 Zimmermann, W., Kammerer, R. (2009). Carcinoembryonic Antigen. Published in Tumor-Associated Antigens: Identification, Characterization, and Clinical Applications. Wiley VCH; 201–218. 7 Locker, G.Y., Hamilton, S., Harris, J., Jessup, J.M., Kemeny, N., Macdonald, J.S., Somerfield, M.R., Hayes, D.F., Bast, Jr R.C. (2006) ASCO 2006 Update of Recommendations for the Use of Tumor Markers in Gastrointestinal Cancer. J. Clin. Oncol; 33, 1-15. 8 Harris, L., Fritsche, H., Mennel, R., Norton, L., Ravdin, P., Taube, S., Somerfield, M.R., Hayes, D.F., Bast Jr R.C. (2007) ASCO 2007 Update of Recommendations for the Use of Tumor Markers in Breast Cancer. J. Clin. Oncol; 33, 5287-5312. 9 Sell, S.S. (1992). Serological Cancer Markers. Humana Press; ISBN 0-89603-209-4. 10Stockley, R.A., Shaw, J., Whitfield, A.G.W., Whitehead, T.P., Clarke, C.A., Burnett, D. (1986). Effect of cigarette smoking, pulmonary inflammation, and lung disease on concentrations of carcinoembryonic antigen in serum and secretions. Thorax; 41, 17-24. 11Bormer, O.P., Thrane-Steen, K. (1991). Epitope group specificity of six immunoassays for carcino-embryonic antigen. Tumor Biol.; 12, 9-15. 12Nussbaum, S., Roth, H.J. (2000). Human anti-mouse antibodies: pitfalls in tumor marker measurement and strategies for enhanced assay robustness; including results with Elecsys CEA. Anticancer Res; 20, 5249-5252. 13Results from the multicenter evaluation. Data on file at Roche.