CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
January 2020—ALPCO announced that the FDA granted its Calprotectin Chemiluminescence ELISA 510(k) clearance. It is intended for in vitro diagnostic use as an aid in the diagnosis of inflammatory bowel disease, specifically Crohn’s disease and ulcerative colitis, and as an aid in the differentiation of IBD from irritable bowel syndrome, in conjunction with other clinical and laboratory findings. The assay exhibits a clinical specificity of 95.1 percent and a clinical sensitivity of 92.1 percent and provides a low false-positive rate. It is capable of quantifying calprotectin levels between 7.9 and 6,000 µg/g from the primary dilution and has a run time of one hour, 32 minutes.
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