Elecsys Cancer antigen 72-4 (CA 72-4)

Electro-chemiluminescence immunoassay
(ECLIA) for the quantitative determination of CA
72-4 in human serum and plasma 1
Indication
Tumor associated glycoprotein (TAG) 72 is a mucin-like protein of high molecular weight (200-400 kD).2 Elevated serum levels
are preferentially found in gastric cancer patients, but can also be found in certain benign diseases like pneumonia, pancreatitis,
liver cirrhosis and ovarian cysts. The most important advantage of CA 72-4 is its particularly high diagnostic specificity for benign
diseases.3 CA 72-4 is a helpful tool in the management of patients with the following diseases:

Gastric cancer:
There is a correlation between the disease stage and the degree of CA 72-4 elevation. After surgery, CA 72-4 levels return to
normal and remain within the normal range in cases where tumor tissue is no longer present. In 70% of relapse cases, CA 72-4
increases prior or concurrently with clinical diagnosis of the relapse.4 There are hints that preoperative CA 72-4 levels can be of
prognostic value.5, 6 The combination of CA 72-4, CA 19-9 and CEA has been shown to increase sensitivity in gastric cancer. 7, 8

Ovarian carcinoma:
Combined use of CA 72-4 and CA 125 enhances diagnostic sensitivity.9

Colorectal carcinoma:
There is a correlation with the clinical staging by Dukes. Diagnostic specificity of CA 72-4 to benign diseases of the colon is 98%
and sensitivity of CA 72-4 can be enhanced by combining it with CEA.10 After complete resection of the tumor a marked drop in CA
72-4 occurs and it remains elevated when a residual tumor is present.

Test principle: one-step sandwich assay

CA 72-4 in Streptavidin
the sample microparticle

Ru
9 min 9 min Ru Measurement

Biotinylated Ruthenylated
monoclonal monoclonal Ru
antibody against antibody against
CA 72-4 CA 72-4
The Elecsys CA 72-4 assay is based on the monoclonal B72.3 and CC49 antibodies 11,12 which are only available from Fujirebio
Diagnostics, its licensees and its representatives.
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 CA 72-4 assay characteristics:

Testing time 18 min.
Test principle One-step sandwich assay
Traceability Standardized against the CA 72-4 enzymun test method. An IRP does
not exist.
Sample material Serum, Na-heparin, Li-heparin, NH 4+-heparin and K 3-EDTA plasma.
Sample volume 30 L
Detection limit 0.20 U/mL
Measuring range (low end defined by lower detection limit) 0.20-300 U/mL
Repeatability cobas e 601 / e 602 modules, E 170: 1.0-2.8%
Elecsys 2010 and cobas e 411 analyzer: 1.8-2.4%
Intermediate precision cobas e 601 / e 602 modules, E 170: 2.2-3.6%
Elecsys 2010 and cobas e 411 analyzer: 2.9-4.9%
Expected values 13 6.9 U/mL for healthy adults (for 95% of the results)

Order information:
Material Product configuration Material number
Elecsys CA 72-4 100 tests 11776258 122
Elecsys CA 72-4 CalSet 4 x 1 mL 11776274 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 Filella, X., Friese, S., Roth, H.J., Nussbaum, S., Wehnl, B. (2000). Technical perfor-
mance of the Elecsys CA 72-4 testdevelopment and field study. Anticancer Res.;
20, 5229-5232.
2 Stieber, P., Fateh-Moghadam, A., Wdlich, H., Nagel, D., Lamerz, R., Denecke, D.
(1990). CA 72-4: A new tumour marker for stomach cancer. In Klapdor R, ed.
Recent results in tumor diagnosis and therapy. Mnchen: Zuckschwerdt; 23-26.
3 Heptner, G., Domschke, S., Domschke, W. (1989). Comparison of CA 72-4 with
CA 19-9 and Carcinoembryonic Antigen in the Serodiagnosis of Gastrointestinal
Malignancies. Scand. J. Gastroenterol.; 24, 745-750.
4 Guadagni, F., Roselli, M., Cosimelli, M., Ferroni, P., Spila, A., Cavaliere, F., Casaldi,
V., Wappner, G., Abbolito, M.R., Greiner, J.W., Schlom, J. (1995). CA 72-4 Serum
Marker - A New Tool in the Management of Carcinoma Patients. Cancer Invest.; 13,
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are trademarks of Roche.
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Roche Diagnostics Ltd.
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227-238.
5 Marrelli, D., Roviello, F., De Stefano, A., Farnetani, M., Garosi, L., Messano, A., Pinto,
E. (1999). Prognostic Significance of CEA, CA 19-9 and CA 72-4. Preoperative
Serum Levels in Gastric Carcinoma. Oncology; 57, 55-62.
6 Louhimo, J., Kokkola, A., Alfthan, H., Stenman, U.H., Haglund, C. (2004). Preopera-
tive hCGbeta and CA 72-4 are prognostic factors in gastric cancer. Int. J. Cancer;
111, 929-933.
7 Ychou, M., Duffour, J., Kramar, A., Gourgou, S., Grenier, J. (2000). Clinical sig-
nificance and prognostic value of CA 72-4 compared with CEA and CA 19-9 in
patients with gastric cancer. Disease markers; 16, 105-110.
8 Feng, M., Yao, L., Weng, L., Chen, L., Feng, G. (2009). Clinical value of tumor mark-
ers combined detection in diagnosis of gastric cancer. Guoji Jianyan Yixue Zazhi;
30, 950-954.
9 Hasholzner, U., Baumgartner, L., Stieber, P., Meier, W., Reiter, W., Pahl, H., Fateh-
Moghadam, A. (1996). Clinical significance of the tumor markers CA 125 II and
CA 72-4 in ovarian carcinoma. Int. J. Cancer (Pred. Oncol.); 69, 329-334.
10 Fermindez-F., L., Tejero, E., Tieso, A. (1995). Significance of CA 72-4 in colorectal
carcinoma. Comparison with CEA and CA 19-9. Eur. J. Surgical Oncol.; 21, 388-390.
11 Johnson, V.G., Schlom, J., Paterson, A.J., Bennett, J., Magnani, J.L., Colcher, D.
(1986). Analysis of a human tumor-associated glycoprotein (TAG-72) identified by
monoclonal antibody B72.3. Cancer Res.; 46, 850-857.
12 Colcher, D., Horan Hand, P., Nuti, M., Schlom, J. (1981). A Spectrum of monoclonal
antibodies reactive with human mammary tumor cells. Proc. Natl. Acad. Sci.; 78,
3199-3208.