Which Fecal Immunochemical Test Should I Choose?

Abstract

Objectives: To summarize the fecal immunochemical tests (FITs) available in the United States, the 2014 pathology proficiency testing (PT) program FIT results, and the literature related to the test characteristics of FITs available in the United States to detect advanced adenomatous polyps (AAP) and/or colorectal cancer (CRC). Methods: Detailed review of the Food and Drug Administration’s Clinical Laboratory Improvement Amendments (CLIA) database of fecal occult blood tests, the 2014 FIT PT program results, and the literature related to FIT accuracy. Results: A search of the CLIA database identified 65 FITs, with 26 FITs available for purchase in the United States. Thirteen of these FITs were evaluated on a regular basis by PT programs, with an overall sensitivity of 99.1% and specificity of 99.2% for samples spiked with hemoglobin. Automated FITs had better sensitivity and specificity than CLIA-waived FITs for detection of AAP and CRC in human studies using colonoscopy as the gold standard. Conclusion: Although many FITs are available in the United States, few have been tested in proficiency testing programs. Even fewer have data in humans on sensitivity and specificity for AAP or CRC. Our review indicates that automated FITs have the best test characteristics for AAP and CRC.