The Clinical Accuracy of the BÜHLMANN fCAL ELISA in the Differentiation of Inflammatory Bowel Disease From Irritable Bowel Syndrome: A Multicenter Prospective Case–Control Study

Abstract Background Fecal calprotectin (fCAL) is a noninvasive biomarker used to differentiate between inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS). Methods A multicenter prospective case–control study evaluating the BÜHLMANN fCAL enzyme-linked immunosorbent assay (ELISA) was conducted in 478 subjects. Sensitivity, specificity, predictive values, and area under the receiver operator characteristic (AuROC) curve are reported and compared to another device. Results In differentiating IBD from IBS, the BÜHLMANN fCAL ELISA is very sensitive (93.3%) at a cutoff <80 μg/g and balanced sensitivity (84.4%) and specificity (85.4%) at a cutoff >160 μg/g (AuROC 0.933). Conclusions The BÜHLMANN fCAL ELISA demonstrates excellent discriminating between IBD and IBS.