This article is more than 5 years old. Information may no longer be current.
FDA Clears Calprotectin Assay for Diagnosing IBD
Click Here to Manage Email Alerts
The FDA has cleared the Quanta Lite Calprotectin Extended Range assay for diagnosing inflammatory bowel disease and for helping to differentiate between IBD and irritable bowel syndrome, the manufacturer announced.
The Quanta Lite Calprotectin Extended Range (Inova Diagnostics) is a quantitative enzyme linked immunosorbent assay (ELISA) that detects calprotectin levels, and provides a broader analytical measuring range relative to other assays cleared by the FDA, according to a press release.
“We are very pleased to launch this high performing assay to meet the increasing demand from laboratories worldwide,” Michael Mahler, PhD, vice president of research and development for Inova Diagnostics, said in the press release. “Gastrointestinal pain is a common reason for seeking medical attention. Inaccurate diagnosis at the screening level can contribute to unnecessary procedures and increased healthcare costs. Quanta Lite Calprotectin Extended Range can improve care while helping reduce costs.”
K. T. Park
According to K.T. Park, MD, MS, chair of clinical care and quality at NASPGHAN and co-director of the Stanford Children’s IBD Center at Stanford University School of Medicine, fecal calprotectin has “revolutionized” his clinical practice in two key ways.
“First, calprotectin measurements during patients’ diagnostic workup, particularly when the diagnosis could be either IBS or IBD, provide direction and important information prior to endoscopic evaluations,” he said in the press release. “Second, calprotectin follow-up testing in IBD patients supports a patient-centered, proactive approach to disease management, allowing accurate detection of indolent and often-missed inflammation.”
Disclosures: Mahler is employed by Inova Diagnostics. Park reports he has served as a consultant for Inova.