FDA Clears First Fully Automated Calprotectin Test for IBD Diagnosis, Inova Says

FDA Clears First Fully Automated Calprotectin Test for IBD Diagnosis, Inova Says
The U.S. Food and Drug Administration (FDA) has approved the QUANTA Flash Calprotectin test to help diagnose inflammatory bowel disease (IBD) and differentiate that disease from irritable bowel syndrome (IBS). Developed by Inova Diagnostics, QUANTA Flash Calprotectin is the first fully automated, random access calprotectin assay given FDA approval. The test is an immunoassay designed to detect IBDs such as Crohn’s disease and ulcerative colitis in fecal calprotectin in human stool samples. Neutrophils have high levels of calprotectin, a protein that binds to calcium and zinc. Neutrophils cause acute inflammation in response to a number of factors, meaning that the amount of calprotectin reflects the concentration of neutrophils in a given inflammation process. The significant correlation between fecal calprotectin and other measures of acute inflammation confirms this link in IBDs. Moreover, calprotectin is resistant to degradation by intestinal pancreatic secretions, intestinal proteases and bacterial degradation, and is stable in feces at room temperature for at least seven days. "Fecal calprotectin has revolutionized my clinical practice.  Calprotectin measurements during patients' diagnostic workup when the diagnosis could be either IBS or IBD provide direction and important information prior to endoscopic evaluations,” Dr. KT Park, chair of clinical care and quality
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