Comparative Performance of Common Fecal Immunochemical Tests

作者：Barcey T. Levy, Yinghui Xu, Jeanette M. Daly, Richard M. Hoffman, Jeffrey D. Dawson, Navkiran K. Shokar, Marc J. Zuckerman, Jennifer Molokwu, Daniel S. Reuland, Seth D. Crockett · 发表于：Annals of Internal Medicine · 年份：2024 · DOI：10.7326/m24-0080 · 被引用次数：19 · 研究领域：Colorectal Cancer Screening and Detection、Microscopic Colitis、Helicobacter pylori-related gastroenterology studies

BACKGROUND: Despite widespread use of fecal immunochemical tests (FITs) for colorectal cancer (CRC) screening, data to guide test selection are limited. OBJECTIVE: To compare the performance characteristics of 5 commonly used FITs, using colonoscopy as the reference standard. DESIGN: Cross-sectional study. (ClinicalTrials.gov: NCT03264898). SETTING: Three U.S. academic medical centers and affiliated endoscopy units. PARTICIPANTS: Patients aged 50 to 85 years undergoing screening or surveillance colonoscopy. INTERVENTION: Participants completed 5 different FITs before their colonoscopy, including 4 qualitative tests (Hemoccult ICT, Hemosure iFOB, OC-Light S FIT, QuickVue iFOB) and 1 quantitative test (OC-Auto FIT, which was run at the manufacturer's threshold for positivity of >100 ng/mL). MEASUREMENTS: The primary outcome was test performance (sensitivity and specificity) for each of the 5 FITs for advanced colorectal neoplasia (ACN), defined as advanced polyps or CRC. Positivity rates, positive and negative predictive values, and rates of unevaluable tests were compared. Multivariable models were used to identify factors affecting sensitivity. RESULTS: A total of 3761 participants were enrolled, with a mean age of 62.1 years (SD, 7.8); 63.2% of participants were female, 5.7% were Black, 86.4% were White, and 28.7% were Hispanic. There were 320 participants with ACN (8.5%), including 9 with CRC (0.2%). The test positivity rate varied 4-fold (3.9% to 16.4%) across FITs. Rates ...