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Elecsys® Cancer antigen 15-3 (CA 15-3)

Electro-chemiluminescence immunoassay
(ECLIA) for the quantitative determination of CA
15-3 in human serum and plasma 1
Indication
CA 15-3 is a high molecular weight (> 400 kD) glycoprotein which belongs to a subgroup of polymorphic epithelial mucins (PEM).2
These mucins are normally found in the luminal secretion of glandular cells and do not circulate in the blood. When these cells
become malignant and their basal membranes permeable, PEMs are detectable in serum using the CA 15-3 assay.

CA 15-3 is a helpful tool in the management of patients with breast cancer:


• It is elevated in approximately 10 % of women with early localized breast cancer. Although it is also elevated in other benign and
malignant diseases such as colorectal cancer, lung cancer, cirrhosis, hepatitis, and benign breast disease, it is the most relevant
tumor marker in breast cancer in combination with the carcinoembryonic antigen (CEA).3
• There is a correlation between both markers and tumor size and nodal involvement, with significantly higher concentrations in
patients with larger tumors.4 Both, CEA and CA 15-3 are useful prognostic factors in nodal positive and nodal negative breast
cancer patients.5
• It is a useful tool in follow-up and therapy monitoring and together with CEA it has been shown to detect 40 - 60 % of recurrences
before clinical or radiological evidence of disease with a lead-time between 2 and 18 months.6
• Simultaneous use of both serum markers allows early diagnosis of metastases in up to 60 - 80 % of patients with breast cancer.7
• It is also recommended by the American Society of Clinical Oncology (ASCO) for monitoring patients with metastatic disease dur-
ing active therapy and can be used in conjunction with diagnostic imaging, history, and physical examination.8

Test principle: one-step sandwich assay

CA 15-3 in Streptavidin
the sample microparticle

Ru
9 min 9 min Ru Measurement

Biotinylated Ruthenylated
monoclonal monoclonal Ru
antibody against antibody against
CA 15-3 CA 15-3

CA 15-3 values measured are defined by the use of the monoclonal antibodies (MAb) 115D8 and DF3. MAb 115D8 is directed
against human milk fat globule membranes 9, whereas MAb DF3 is directed against the membrane fraction from human meta-
static breast cancer.10
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® CA 15-3 assay characteristics:


Testing time 18 min.
Test principle One-step sandwich assay
Traceability Standardized against the CA 15-3 enzymun test method which in turn
has been standardized against the CA 15-3 RIA by Fujirebio Diagnos-
tics. An IRP does not exist.
Sample material Serum, Li-, Na- and NH 4+-heparin and K 3-EDTA plasma
Sample volume 20 µL
Detection limit 1.0 U/mL
Measuring range (low end defined by lower detection limit) 1.0 - 300 U/mL
Repeatability cobas e 601 / e 602 modules, E 170: 1.2 - 1.5 %
Elecsys® 2010 and cobas e 411 analyzer: 2.1 - 3.7  %
Intermediate precision cobas e 601 / e 602 modules, E 170: 3.2 - 5.0 %
Elecsys® 2010 and cobas e 411 analyzer: 3.6 - 4.3 %
Expected values 11 ≤ 25 U/mL for healthy adults (95th percentile)

Order information:
Material Product configuration Material number
Elecsys® CA 15-3 100 tests 03045838 122
Elecsys® CA 15-3 CalSet 4 x 1 mL 03045846 122
PreciControl Tumormarker 2 x 3 mL each 11776452 122
Diluent Universal 2 x 16 mL sample diluent or 11732277 122 or
2 x 36 mL sample diluent 03183971 122

References:
1 Stieber, P., Molina, R., Chan, D.W., Fritsche, H.A., Beyrau, R., Bonfrer, J.M.G., Filella, 4 Stieber, P., Sauer, H., Untch, M. (2001). Tumor markers in breast cancer. J. Lab.
X., Gornet, T.G., Hoff, T., Jaeger, W., Van Kamp, G.J., Nagel, D., Peisker, K., Sokoll, Med.; 25, 343-352.
L.J., Troalen, F.U., Domke, I. (2001). Clinical evaluation of the Elecsys CA 15-3 test 5 Molina, R., Auge, J.M., Farrus, B., Zanón, G., Pahisa, J., Muñoz, M., Torne, A., Filella,
in breast cancer patients. Clin. Chem.; 47, 2162-2164. X., Escudero, J.M., Fernandez, P., Velasco, M. (2010). Prospective Evaluation of Car-
2 Sekine, H., et al. (1985) Purification and characterization of a high molecular weight cinoembryonic Antigen (CEA) and Carbohydrate Antigen 15.3 (CA 15.3) in Patients
glycoprotein detectable in human milk and breast carcinomas. J. Immunology; with Primary Locoregional Breast Cancer. Clin. Chem.; 56, 1148-1157.
135, 3610-3615. 6 Jaeger, W., Eibner, K., Loffler, B., Gleixner, S., Kramer, S. (2000). Serial CEA and CA
3 See also Fact Sheet for Elecsys CEA. 15-3 measurements during follow-up of breast cancer patients. Anticancer Res.;
20, 5179-5182.
7 Molina, R., Barak, V., van Dalen, A., Duffy, M.J., Einarsson, R., Gion, M., Goike, H.,
Lamerz, R., Nap, M., Soletormos, G., Stieber, P. (2005). Tumor markers in breast
cancer – European Group on Tumor Markers recommendations. Tumour Biol.;
26, 281-293.
Not for distribution in the USA. 8 Harris, L., Fritsche, H., Mennel, R., Norton, L., Ravdin, P., Taube, S., Somerfield, M.R.,
Hayes, D.F., Bast Jr., R.C. (2007). American Society of Clinical Oncology 2007 Update
COBAS, COBAS E, LIFE NEEDS ANSWERS and ELECSYS of Recommendations for the Use of Tumor Markers in Breast Cancer. J. Clin. Oncol.;
are trademarks of Roche. 25, 5287-5312.
9 Hilkens, J., et al. (1984). Monoclonal antibodies against human milkfat globule
©2011 Roche membranes detecting differentiation antigens of the mammary gland and its
tumors. Int. J. Cancer; 34, 197-206.
Roche Diagnostics Ltd. 10 Kufe, D., et al. (1984). Differential reactivity of a novel monoclonal antibody (DF3)
CH-6343 Rotkreuz with human malignant versus benign breast tumor. Hybridoma; 3, 223-232.
Switzerland 11 Results from the multicenter evaluation. Data on file at Roche.
www.cobas.com

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