Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2012, 156(2):143-150 | DOI: 10.5507/bp.2012.030

Improvements in colorectal cancer screening programmes – quantitative immunochemical faecal occult blood testing – how to set the cut-off for a particular population

Jaroslava Tereza Kovarovaa, Miroslav Zavoralb, Tomas Zimac, Ales Zaka, Petr Kocnac, Pavel Kohoutd, Jana Granatovae, Zdislava Vanickovac, Jana Vranovaf, Stepan Suchanekb, Zdenek Benesd, Martin Alexander Celkog, Ctibor Povysilh
a 4th Department of Internal Medicine, General Teaching Hospital, First Faculty of Medicine, Charles University Prague, Czech Republic
b Department of Internal Medicine, Central Military Hospital, First Faculty of Medicine, Charles University Prague
c Department of Clinical Chemistry and Laboratory Diagnostics, First Faculty of Medicine, Charles University Prague
d 2nd Department of Internal Medicine, Thomayer Teaching Hospital Prague
e Department of Clinical Chemistry, Thomayer Teaching Hospital Prague
f Department of Medical Biophysics and Informatics, Third Faculty of Medicine, Charles University Prague
g Department of Epidemiology, Third Faculty of Medicine, Charles University Prague
h Department of Pathology, First Faculty of Medicine, Charles University Prague

Objective: The aim of the study was to determine the optimum cut-off value of the quantitative immunochemical test (q-FIT) OC-Sensor® for colorectal cancer and advanced adenomatous polyps in a particular population.

Methods: 815 patients were referred for colonoscopy and were offered two q-FIT examinations at two different colonoscopy centers. The patients were classified according to the colonoscopic findings. Test sensitivity, specificity, and accuracy were statistically evaluated using one test and two tests at the levels of 50, 75, 100, 125, and 150 ng/mL of faecal hemoglobin in those patients with advanced polyps and colorectal cancer. The optimum cut-off test level for clinically significant neoplasia was determined using one test.

Results: The optimum cut-off value of q-FIT OC-Sensor® for the detection of clinically significant neoplasia in our particular population was determined as 75 ng/mL using one test. This value provides an optimum proportion of 73% sensitivity (±95% CI 60.3% - 83.4%) and 90% specificity (±95% CI 86.8% - 92.8%), PPV and NPV were determined as 54.76% and 95.43% respectively.

Conclusions: The first step in the implementation of q-FIT test in the screening program in our country is to determine the optimum cut-off level for a population, and to estimate the number of tests performed with respect to the optimum cost effectiveness and economical climate. Using one test, the optimum level of q-FIT OC-Sensor® in the Czech Republic was determined as 75 ng/mL. This study could serve as a model for further studies in other countries, where screening does not yet exist.

Keywords: cut-off, quantitative immunochemical test, colorectal cancer, screening, Czech Republic

Received: October 7, 2011; Accepted: February 27, 2012; Published: June 1, 2012  Show citation

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Kovarova, J.T., Zavoral, M., Zima, T., Zak, A., Kocna, P., Kohout, P., ... Povysil, C. (2012). Improvements in colorectal cancer screening programmes – quantitative immunochemical faecal occult blood testing – how to set the cut-off for a particular population. Biomedical papers, 156(2), 143-150. doi: 10.5507/bp.2012.030
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