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FDA Clears Automated Calprotectin Test for IBD
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The FDA has cleared a fully automated random access calprotectin assay to assist in the diagnosis of inflammatory bowel disease in the U.S., the manufacturer announced.
The Quanta Flash Calprotectin (Inova Diagnostics) is a chemiluminescence immunoassay that detects fecal calprotectin in stool samples. It is performed using a random access chemiluminescent instrument called Bio-Flash, which produces results as quickly as 30 minutes, according to a press release.
When combined with clinical findings and other lab tests, high fecal calprotectin levels can help diagnose and manage ulcerative colitis and Crohn’s disease, and can also help distinguish between IBD and irritable bowel syndrome (IBS), the company noted.
According to K.T. Park, MD, MS, chair of clinical care and quality for the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN), and co-director of the Stanford Children’s IBD Center at Stanford University School of Medicine, this new assay is an important asset in clinical decision making.
“Fecal calprotectin has revolutionized my clinical practice,” he said in the press release. “Calprotectin measurements during patients’ diagnostic workup when the diagnosis could be either IBS or IBD provide direction and important information prior to endoscopic evaluations. Calprotectin testing supports a patient-centered, proactive approach to disease management, allowing accurate detection of indolent and often-missed inflammation.”
The new assay, which Park called “highly accurate,” provides an analytical measurement range up to 3,500 mg/kg, and can help improve patient care while reducing costs, according to the press release.
Disclosures: Park reports consulting for Inova.