Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis

Ann Intern Med. 2014 Feb 4;160(3):171. doi: 10.7326/M13-1484.


Background: Performance characteristics of fecal immunochemical tests (FITs) to screen for colorectal cancer (CRC) have been inconsistent.

Purpose: To synthesize data about the diagnostic accuracy of FITs for CRC and identify factors affecting its performance characteristics.

Data sources: Online databases, including MEDLINE and EMBASE, and bibliographies of included studies from 1996 to 2013.

Study selection: All studies evaluating the diagnostic accuracy of FITs for CRC in asymptomatic, average-risk adults.

Data extraction: Two reviewers independently extracted data and critiqued study quality.

Data synthesis: Nineteen eligible studies were included and meta-analyzed. The pooled sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio of FITs for CRC were 0.79 (95% CI, 0.69 to 0.86), 0.94 (CI, 0.92 to 0.95), 13.10 (CI, 10.49 to 16.35), 0.23 (CI, 0.15 to 0.33), respectively, with an overall diagnostic accuracy of 95% (CI, 93% to 97%). There was substantial heterogeneity between studies in both the pooled sensitivity and specificity estimates. Stratifying by cutoff value for a positive test result or removal of discontinued FIT brands resulted in homogeneous sensitivity estimates. Sensitivity for CRC improved with lower assay cutoff values for a positive test result (for example, 0.89 [CI, 0.80 to 0.95] at a cutoff value less than 20 µg/g vs. 0.70 [CI, 0.55 to 0.81] at cutoff values of 20 to 50 µg/g) but with a corresponding decrease in specificity. A single-sample FIT had similar sensitivity and specificity as several samples, independent of FIT brand.

Limitations: Only English-language articles were included. Lack of data prevented complete subgroup analyses by FIT brand.

Conclusion: Fecal immunochemical tests are moderately sensitive, are highly specific, and have high overall diagnostic accuracy for detecting CRC. Diagnostic performance of FITs depends on the cutoff value for a positive test result.

Primary funding source: National Institute of Diabetes and Digestive and Kidney Diseases and National Cancer Institute.

Publication types

  • Meta-Analysis
  • Research Support, N.I.H., Extramural
  • Review
  • Systematic Review

MeSH terms

  • Adult
  • Colorectal Neoplasms / diagnosis*
  • Early Detection of Cancer / methods
  • Feces / chemistry*
  • Humans
  • Immunochemistry / standards*
  • Occult Blood
  • Sensitivity and Specificity