Risk factors for false positive and for false negative test results in screening with fecal occult blood testing

Int J Cancer. 2013 Nov 15;133(10):2408-14. doi: 10.1002/ijc.28242. Epub 2013 Jun 25.


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.

Keywords: colorectal cancer; false negative; false positive; fecal immunochemical test; prevention; screening.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Clinical Laboratory Techniques / methods
  • Clinical Laboratory Techniques / standards*
  • Colonoscopy / methods
  • False Negative Reactions
  • False Positive Reactions
  • Feces / chemistry*
  • Female
  • Humans
  • Male
  • Mass Screening / methods
  • Mass Screening / standards
  • Middle Aged
  • Occult Blood*
  • Pilot Projects
  • Risk
  • Risk Factors
  • Sensitivity and Specificity