Systematic Review and Meta-analysis of the Diagnostic Accuracy of Quantitative Fecal Immunochemical Tests by Sex, Geographic Region, and Test Characteristics.

PURPOSE: Fecal immunochemical tests (FIT) are widely used for colorectal cancer (CRC) screening. This systematic review and meta-analysis evaluated the diagnostic accuracy of quantitative FIT for CRC and advanced neoplasm (AN), and examined variations in performance by sex, geographic region, study design, FIT platform, and positivity threshold. MATERIALS AND METHODS: A comprehensive search of MEDLINE, Embase, Cochrane Library, and KoreaMed was conducted. Studies evaluating the accuracy of quantitative FIT for CRC or AN using colonoscopy as a reference standard were included. The pooled sensitivity and specificity were estimated using a bivariate random-effects model. Meta-regression analysis was performed to analyze the diagnostic differences between sexes. RESULTS: Thirty-three studies were included. FIT showed higher sensitivity for CRC than for AN (78.6% vs. 32.3%), with high specificity for both outcomes (93.7% and 95.2%, respectively). Case-control studies yielded a significantly higher AN sensitivity than cohort studies (50.7% vs. 29.7%; p<0.05). Western studies showed significantly higher AN sensitivity and lower specificity than Eastern studies (31.6% vs. 24.2%, p<0.05; and 95.0% vs. 96.5%, p<0.05, respectively). In the sex-stratified analyses, males showed higher AN sensitivity than females (34.1% vs. 30.8%) and significantly lower CRC specificity (90.1% vs. 93.1%; p<0.05); however, the meta-regression showed no significant sex effect on the overall diagnostic accuracy for CRC or AN. CONCLUSION: Quantitative FIT demonstrated strong performance for CRC detection but limited sensitivity for AN. Variations in the study design, FIT platform, threshold, region, and sex should be considered when interpreting FIT accuracy.