Evaluation of Fecal Immunochemical Tests for Colorectal Cancer Screening

Abstract

Background: Colorectal cancer (CRC) screening reduces the mortality due to CRC. It is important for health care providers to be aware of the variation in the products available for CRC screening. Purpose: The purpose of this study was to summarize the accuracy of results of individual fecal immunochemical test (FIT) products across pathology proficiency testing programs. Methods: Secondary data analysis of proficiency testing programs’ FIT results. Results: Four of 7 proficiency testing program’s FIT evaluations were obtained for a 2-year period. Fourteen unique FIT brands were evaluated by at least 1 of the 4 proficiency testing programs. Five of the products performed similarly with sensitivities ranging from 98.1% to 98.8% and specificities from 98.1% to 99.6%. Ninety-three percent of the FIT tests completed were manual Clinical Laboratory Improvement Amendments–waived FITs. Conclusions: About two thirds of the commonly used FIT products performed acceptably on spiked samples of human hemoglobin. However, some had low sensitivity and specificity and probably should not be used for population-based or other screening. Further investigation to determine appropriate, reliable products for fecal occult blood testing is warranted.