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Validation of Fecal Calprotectin (fCal ®turbo) by an Automated Routine Chemistry Analyzer on Architect C 4000 Platform

AACC 2020 -- Guideline for inflammatory bowel disease (IBD) suggests using fecal calprotectin (FC) for patient during diagnostic and monitoring phases, as well as in distinguishing between IBD and IBS (irritable bowel syndrome). Crohn's disease and ulcerative colitis are the principle types of Inflammatory bowel disease. Fecal Calprotectin (FC) is a heterodimeric protein (S100A8/A9) released by granulocytes, monocytes, macrophages and epithelial cells during inflammatory response, with inflammatory cells accumulating in mucosa. FC is released into the stool, from where is can be measured using commercially available assays. Bühlmann (Bühlmann Laboratories AG, Switzerland) has developed a fully automated turbidimetric immunoassay for calprotectin analysis. The purpose of this study is to evaluate the performance of this assay as per CLSI guidelines and compare the results of the assay with Bühlmann ELISA.