The Czech Republic has one of the highest incidences and mortality of colorectal cancer worldwide. An alarming rate of incidence (79/100,000) and mortality (45/100, 000) has remained almost unchanged over the past years.
Recently, a new generation of quantitative fecal immunochemical test (q-FIT) is available, the advantage of which is obtaining optimum test sensitivity and specificity for a particular population by setting a cut-off value. AIMS & METHODS: The aim of the study was to determine the optimum cut-off value of quantitative immunochemical test (q-FIT) OC-Sensor® for colorectal cancer and advanced adenoma polyps in the Czech population.
METHOD: 815 patients referred to colonoscopy were offered two q-FIT examinations at two different colonoscopy centers. The patients were stratified according to the colonoscopy findings.
Mean and 95% CI of fecal hemoglobin were calculated according to the pathological 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 fecal hemoglobin in the patients with advanced polyps and colorectal cancer, and 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.