The Diagnostic Accuracy (DA) of ColonView Fecal Immunochemical Test (FIT) in Detecting Colorectal Adenoma (CRA) Can Be Improved by the Diagnostic Models (DM) that Include Triage and Risk Features of CRA.

Abstract

This study assessed whether the diagnostic accuracy (DA) of ColonView (CV) fecal immunochemical test (FIT) in detecting colorectal adenoma (CRA) can be improved by the diagnostic models (DM) that include triage and risk features of CRA. A total of 5,090 participants of colorectal neoplasia (CRN) screening were recruited prospectively between January 2014 and December 2016. The CRN cohort of 486 patients included 222 CRA patients and 264 non-CRA patients of whom three consecutive fecal samples were analyzed by two fecal occult blood (FOB) assays (CV FIT test, HemoccultSENSA test). Hierarchical multilevel logistic models were used to test the DA of CV test and DMs, visualised as hierarchical summary receiving operating characteristic (HSROC) curves. In conventional receiving operating characteristic (ROC) analysis, the area under the curve (AUC) values of the age, height, weight, and body mass index (BMI) were 0.60, 0.57, 0.54, and 0.51, respectively. The AUC values for different DMs ranged from 0.69 (for DM without triage I/II and SENSA), and the highest AUC value of 0.70 was reached for DM with all variables included. In HSROC analysis, the AUC values for i) lowR variables, ii) highR variables, and ii) DMs were as follows: i) AUC=0.506, ii) AUC=0.566 and iii) AUC=0.732. The differences in AUC values were: between i) and ii) p=0.008; between i) and iii) p<0.0001; between ii) and iii) p<0.0001. The results demonstrated that DMs, particularly those including risk factors, significantly improved the DA of the CV FIT test in detecting CRA compared to traditional low-risk (lowR) and high-risk (highR) features alone. This study provides novel evidence supporting the enhanced diagnostic performance of DMs in combination with CV FIT testing for the detection of CRA.