Comparison of One versus Two Fecal Immunochemical Tests in the Detection of Colorectal Neoplasia in a Population-Based Colorectal Cancer Screening Program.

Objective. To determine the positive predictive value (PPV) of two versus one abnormal FIT in the detection of colorectal neoplasia in a Canadian population. Methods. Three communities enrolled in a colorectal cancer (CRC) screening pilot program from 01/2009 to 04/2013 using 2 FITs. Data collected included demographics, colonoscopy, pathology, and FIT results. Participants completed both FITs and had one positive FIT and colonoscopy. PPV of one versus two abnormal FITs was calculated using a weighted-generalized score statistic. A two-sided 5% significance level was used. Results. 1576 of 17,031 average-risk participants, 50-75 years old, had a positive FIT. Colonoscopy revealed 58 (3.7%) cancers, 419 (31.6%) high-risk polyps, and 374 (23.7%) low-risk polyps as the most significant lesion. PPV of one versus two positive FITs for cancer, high-risk polyps, and any neoplasia were 1% versus 8%, 20% versus 40%, and 48% versus 67%, respectively (p value < 0.0001). When the first FIT was negative, the second positive FIT detected 7 CRCs and 98 high-risk polyps. Conclusions. PPV of two positive FITs is superior to one positive FIT for CRC and high-risk polyps. The added value of the second FIT was 12% of total CRCs and 23% of total high-risk polyps.