Download Elecsys Carcinoembryonic antigen

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.