The Calprotectin Immunoturbidimetric Assay is an in vitro diagnostic particle-enhanced immunoassay intended for use by trained laboratory personnel for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of intestinal mucosal inflammation, in human stool. The Calprotectin Immunoturbidimetric Assay is intended for in vitro diagnostic use as an aid in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC), and as an aid in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other clinical and laboratory findings.
The Calprotectin Immunoturbidimetric Assay is used in conjunction with two accessories, the Calprotectin Control Set (80-CALPHU-ITCON) and Calprotectin Calibrator Set (80-CALPHU-ITCAL), and a compatible clinical chemistry analyzer.
For in vitro diagnostic use in the United States, Canada, and the European Union.
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