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 recommenda-
tions 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 diag-
nostic 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 Streptavidin
the sample microparticle

Ru
9 min 9 min Ru Measurement

Biotinylated Ruthenylated
chimeric human/ monoclonal Ru
mouse antibody antibody against
against human CEA human CEA

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 Roches 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 18 min
Test principle One-step sandwich assay
Traceability IRP WHO Reference Standard 73/601
Sample material Serum, Li-heparin, Na-heparin, K3-EDTA and sodium citrate plasma.
When sodium citrate is used, the results must be corrected by + 10%
Sample volume 10 L
Detection limit 0.20 ng/mL
Measuring range (low end defined by lower detection limit) 0.20-1000 ng/mL
Repeatability cobas e 601 / e 602 modules, E 170: 1.0-2.5%
Elecsys 2010 and cobas e 411 analyzer: 1.3-5.0%
Intermediate imprecision cobas e 601 / e 602 modules, E 170: 4.6-5.1%
Elecsys 2010 and cobas e 411 analyzer: 2.0-5.4%
Expected values 20-69 years (for 95% of the results)
- non-smokers: 3.8 ng/mL
- smokers: 5.5 ng/mL

Order information:
Material Product configuration Material number
Elecsys CEA 100 tests 11731629 322
200 tests 04491777 190
Elecsys CEA CalSet 4 x 1 mL 11731645 322
PreciControl Tumormarker or 2 x 3 mL each 11776452 122 or
PreciControl Universal 11731416 122
Diluent Universal 2 x 16 mL sample diluent or 11732277 122 or
2 x 36 mL sample diluent 03183971 122

References:
1 Gold, P., Freedman, S.O. (1965). Demonstration of tumor-specific antigen in human 5 Wild, N., Herbert, A., Rollinger, W., Krause, F., Dilba, P., Tacke, M., Karl, J. (2010). A
colonic carcinomata. J. Exp. Med.; 121, 439. Combination of Serum Markers for the Early Detection of Colorectal Cancer. Clin.
2 Thompson, J.A. (1995). Molecular cloning and expression of carcinoembryonic Cancer Res.; 16, 6111-6121.
antigen gene family members. Tumor Biol.; 16, 10-16. 6 Zimmermann, W., Kammerer, R. (2009). Carcinoembryonic Antigen. Published in
3 Ballesta, A.M., Molina, R., Filella, X., Jo, J., Gimenez, N. (1995). Carcinoembryonic Anti- Tumor-Associated Antigens: Identification, Characterization, and Clinical Applica-
gen in Staging and Follow-up of Patients with Solid Tumors. Tumor Biol.; 16, 32-41. tions. Wiley VCH; 201218.
4 Nielsen, H.J., Brunner, N., Jorgensen, L.N., Olsen, J., Rahr, H.B., Thygesen, K., Hoyer, U., 7 Locker, G.Y., Hamilton, S., Harris, J., Jessup, J.M., Kemeny, N., Macdonald, J.S., Somer-
Laurberg, S., Stieber, P., Blankenstein, M.A., Davis, G., Dowell, B.L., Christensen, I.J. (2011). field, M.R., Hayes, D.F., Bast, Jr R.C. (2006) ASCO 2006 Update of Recommendations
Plasma TIMP-1 and CEA in detection of primary colorectal cancer: a prospective, popu- for the Use of Tumor Markers in Gastrointestinal Cancer. J. Clin. Oncol; 33, 1-15.
lation based study of 4509 high-risk individuals. Scand. J. Gastroenterol.; 46, 60-69. 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
Not for distribution in the USA. 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.
COBAS, COBAS E, LIFE NEEDS ANSWERS and ELECSYS 10 Stockley, R.A., Shaw, J., Whitfield, A.G.W., Whitehead, T.P., Clarke, C.A., Burnett, D. (1986).
are trademarks of Roche. Effect of cigarette smoking, pulmonary inflammation, and lung disease on concentra-
tions of carcinoembryonic antigen in serum and secretions. Thorax; 41, 17-24.
2011 Roche 11 Bormer, O.P., Thrane-Steen, K. (1991). Epitope group specificity of six immunoas-
says for carcino-embryonic antigen. Tumor Biol.; 12, 9-15.
Roche Diagnostics Ltd. 12 Nussbaum, S., Roth, H.J. (2000). Human anti-mouse antibodies: pitfalls in tumor
CH-6343 Rotkreuz marker measurement and strategies for enhanced assay robustness; including
Switzerland results with Elecsys CEA. Anticancer Res; 20, 5249-5252.
www.cobas.com 13 Results from the multicenter evaluation. Data on file at Roche.