Differences in the risk of a false negative or a false positive fecal immunochemical test (FIT) across subgroups may affect optimal screening strategies. We evaluate whether subgroups are at increased risk of a false positive or a false negative FIT result, whether such variability in risk is related to differences in FIT sensitivity and specificity or to differences in prior CRC risk. Randomly selected, asymptomatic individuals were invited to undergo colonoscopy. Participants were asked to undergo one sample FIT and to complete a risk questionnaire. We identified patient characteristics associated with a false negative and false positive FIT results using logistic regression. We focused on statistically significant differences as well as on variables influencing the false positive or negative risk for which the odds ratio exceeded 1.25. Of the 1,426 screening participants, 1,112 (78%) completed FIT and the questionnaire; 101 (9.1%) had advanced neoplasia. 102 Individuals were FIT positive, 65 (64%) had a false negative FIT result and 66 (65%) a false positive FIT result. Participants at higher age and smokers had a significantly higher risk of a false negative FIT result. Males were at increased risk of a false positive result, so were smokers and regular NSAID users. FIT sensitivity was lower in females. Specificity was lower for males, smokers and regular NSAID users. FIT sensitivity was lower in women. FIT specificity was lower in males, smokers and regular NSAID users. Our results can be used for further evidence based individualization of screening strategies. What's new? Fecal immunochemical testing (FIT) is used as a non-invasive triaging test for colonoscopy in screening programs for colorectal-cancer (CRC). In this study, the authors examined whether certain subgroups of people have an increased risk of inaccurate FIT results. They found that men, smokers and regular NSAID users had higher rates of false-positive results, while the chances of having a false negative FIT are higher in smokers and in people at advanced age. Sensitivity was also lower in women. These results may be useful for improving CRC screening strategies. Copyright

adult, advanced cancer, article, asymptomatic disease, cancer screening, colonoscopy, colorectal cancer, controlled study, diagnostic test, diagnostic test accuracy study, drug use, false negative result, false positive result, fecal immunochemical test, female, high risk patient, human, human tissue, major clinical study, male, multicenter study, occult blood test, patient information, priority journal, questionnaire, randomized controlled trial, receiver operating characteristic, risk assessment, risk factor, sensitivity and specificity, sex difference, smoking
dx.doi.org/10.1002/ijc.28242, hdl.handle.net/1765/41680
International Journal of Cancer
Erasmus MC: University Medical Center Rotterdam

Stegeman, I, de Wijkerslooth, T.R, Stoop, E, van Leerdam, M.E, van Ballegooijen, M, Kraaijenhagen, R.A, … Bossuyt, P.M.M. (2013). Risk factors for false positive and for false negative test results in screening with fecal occult blood testing. International Journal of Cancer, 133(10), 2408–2414. doi:10.1002/ijc.28242