The New Generation Immunochemical Test for Fecal Occult Blood (ColonView Quick Test) Shows a High Diagnostic Accuracy in Colorectal Cancer Detection

Abstract

Background/aim: The present study compared the accuracy of visually analyzed (VA) and automatically analyzed (AA) ColonView (CV) quick test; a new-generation immunochemical test (FIT) for Hb and Hb/Hp (Biohit Oyj, Helsinki, Finland) in subjects participating in colorectal cancer (CRC) detection in Brazil. A traditional gFOBT test (HemoccultSENSA) was used as a reference.

Patients and methods: A cohort of 368 colonoscopy-referral patients were asked to collect 3 consecutive fecal samples, to be analysed by both assays (CV, SENSA).

Results: In receiver operating characteristic (ROC) analysis for the AA reading, the optimal cut-off value for CV Hb AA (test AA 3) was ≥117 and that for CV Hb/Hp AA (test AA 4) was ≥48. In the hierarchical summary receiver operating characteristic (HSROC) analysis for pooled accuracy of CV with AA and VA reading, the AUC values for i) VA and ii) AA were as follows: i) AUC=0.859 (95%CI=0.839-0.879), ii) AUC=0.931 (95%CI=0.920-0.942). The difference between these AUC values (Roccomp analysis) was statistically significant (p=0.0024).

Conclusion: The present study confirms the previous studies on the applicability of the ColonView quick test (a new-generation FIT) in CRC screening.

Keywords: FIT; Fecal occult blood; HSROC; ROC; colorectal cancer screening; false negative; false positive; fecal immunochemical test; sensitivity; specificity.