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Elecsys ® Cancer antigen 15-3 (CA 15-3) Electro-chemiluminescence immunoassay (ECLIA) for the quantitative
Elecsys ® Cancer antigen 15-3 (CA 15-3) Electro-chemiluminescence immunoassay (ECLIA) for the quantitative

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


the sample



9 min





antibody against

antibody against

CA 15-3

CA 15-3


9 min



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

membranes 9 , whereas MAb DF3 is directed against the membrane fraction from human meta- static
membranes 9 , whereas MAb DF3 is directed against the membrane fraction from human meta- static

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


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


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 (95 th percentile)


Order information:


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 2 x 36 mL sample diluent



122 or




1 Stieber, P., Molina, R., Chan, D.W., Fritsche, H.A., Beyrau, R., Bonfrer, J.M.G., Filella, X., Gornet, T.G., Hoff, T., Jaeger, W., Van Kamp, G.J., Nagel, D., Peisker, K., Sokoll, L.J., Troalen, F.U., Domke, I. (2001). Clinical evaluation of the Elecsys CA 15-3 test in breast cancer patients. Clin. Chem.; 47, 2162-2164.

2 Sekine, H., et al. (1985) Purification and characterization of a high molecular weight glycoprotein detectable in human milk and breast carcinomas. J. Immunology; 135, 3610-3615.

3 See also Fact Sheet for Elecsys CEA.

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

4 Stieber, P., Sauer, H., Untch, M. (2001). Tumor markers in breast cancer. J. Lab. Med.; 25, 343-352.

5 Molina, R., Auge, J.M., Farrus, B., Zanón, G., Pahisa, J., Muñoz, M., Torne, A., Filella, X., Escudero, J.M., Fernandez, P., Velasco, M. (2010). Prospective Evaluation of Car- cinoembryonic Antigen (CEA) and Carbohydrate Antigen 15.3 (CA 15.3) in Patients with Primary Locoregional Breast Cancer. Clin. Chem.; 56, 1148-1157.

6 Jaeger, W., Eibner, K., Loffler, B., Gleixner, S., Kramer, S. (2000). Serial CEA and CA 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.

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 of Recommendations for the Use of Tumor Markers in Breast Cancer. J. Clin. Oncol.; 25, 5287-5312.

9 Hilkens, J., et al. (1984). Monoclonal antibodies against human milkfat globule membranes detecting differentiation antigens of the mammary gland and its tumors. Int. J. Cancer; 34, 197-206.

10 Kufe, D., et al. (1984). Differential reactivity of a novel monoclonal antibody (DF3) with human malignant versus benign breast tumor. Hybridoma; 3, 223-232.

11 Results from the multicenter evaluation. Data on file at Roche.