Random Comparison of Guaiac and Immunochemical Fecal Occult Blood Tests for Colorectal Cancer in a Screening Population

Background & Aims: Despite poor performance, guaiac-based fecal occult blood tests (G-FOBT) are most frequently implemented for colorectal cancer screening. Immunochemical fecal occult blood tests (I-FOBT) are claimed to perform better, without randomized comparison in screening populations. Our aim was to randomly compare G-FOBT with I-FOBT in a screening population. Methods: We conducted a population-based study on a random sample of 20,623 individuals 50–75 years of age, randomized to either G-FOBT (Hemoccult-II) or I-FOBT (OC-Sensor). Tests and invitations were sent together. For I-FOBT, the standard cutoff of 100 ng/ml was used. Positive FOBTs were verified with colonoscopy. Advanced adenomas were defined as ≥10 mm, high-grade dysplasia, or ≥20% villous component. Results: There were 10,993 tests returned: 4836 (46.9%) G-FOBTs and 6157 (59.6%) I-FOBTs. The participation rate difference was 12.7% (P < .01). Of G-FOBTs, 117 (2.4%) were positive versus 339 (5.5%) of I-FOBTs. The positivity rate difference was 3.1% (P < .01). Cancer and advanced adenomas were found, respectively, in 11 and 48 of G-FOBTs and in 24 and 121 of I-FOBTs. Differences in positive predictive value for cancer and advanced adenomas and cancer were, respectively, 2.1% (P = .4) and −3.6% (P = .5). Differences in specificities favor G-FOBT and were, respectively, 2.3% (P < .01) and −1.3% (P < .01). Differences in intention-to-screen detection rates favor I-FOBT and were, respectively, 0.1% (P < .05) and 0.9% (P < .01). Conclusions: The number-to-scope to find 1 cancer was comparable between the tests. However, participation and detection rates for advanced adenomas and cancer were significantly higher for I-FOBT. G-FOBT significantly underestimates the prevalence of advanced adenomas and cancer in the screening population compared with I-FOBT.

Abbreviations used in this paper: 95% CI, 95% confidence interval, CRC, colorectal cancer, FOBT, fecal occult blood test, G-FOBT, guaiac-based fecal occult blood test, I-FOBT, immunochemical fecal occult blood test, Negatives, FOBT-negative patients, Positives, FOBT-positive patients, PPV, positive predictive value