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

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

Abstract

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.

PMID:
24658694
PMCID:
PMC4189821
DOI:
10.7326/M13-1484
[Indexed for MEDLINE]
Free PMC Article

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