Fecal calprotectin is a calcium- and zinc-binding protein that is a potential indicator of intestinal inflammation. Fecal calprotectin testing has been proposed as a noninvasive test to diagnose inflammatory bowel disease (IBD), Crohn’s disease, and ulcerative colitis. Other potential uses are to differentiate IBD from irritable bowel syndrome (IBS) when used in conjunction with other diagnostic testing and the total clinical picture. This test has also been proposed to evaluate response to treatment for patients with IBD and as a marker of relapse.
Fecal calprotectin testing for the diagnosis and management of intestinal conditions, including, but not limited to inflammatory bowel disease is considered investigational.
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The diagnostic accuracy of fecal calprotectin is uncertain, as are the clinical management changes associated with specific calprotectin levels. The evidence is insufficient to determine the effects of the technology on health outcomes.
American College of Gastroenterology. (2018, March) ACG clinical guideline: management of crohn’s disease in adults. Retrieved October 26, 2018 from https://gastroenterology.acponline.org.
BlueCross BlueShield Association. Evidence Positioning System. (3:2018). Fecal Calprotectin Testing (2.04.69). Retrieved October 26, 2018 from http://www.evidencepositioningsystem.com. (19 articles and/or guidelines reviewed)
Chey, W., Kurlander, J., & Eswaran, S. (2015). Irritable bowel syndrome, a clinical review. The Journal of the American Medical Association, 313 (9), 949-959. (Level 1 evidence)
Kawashima, K., Ishihara, S., Yuki, T., Fukuba, N., Oshima, N., Kazumori, H., et al. (2016). Fecal calprotectin level correlated with both endoscopic severity and disease extent in ulcerative colitis. BMC Gastroenterology, 16, 47. (Level 3 evidence)
Menees, S., Powell, C., Kurlander, J., Goel, A., & Chey, W. (2015). A meta-analysis of the utility of c-reactive protein, erythrocyte sedimentation rate, fecal calprotectin, and fecal lactoferrin to exclude inflammatory bowel disease in adults with IBS. The American Journal of Gastroenterology, 110, 444-454. (Level 1 evidence)
National Institute for Health and Care Excellence. (2013). Faecal calprotectin diagnostic tests for inflammatory diseases of the bowel. Retrieved February 24, 2016 from http://www.nice.org.uk.
U. S. Food and Drug Administration. (2006, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K050007 (PhiCal®). Retrieved September 15, 2011 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2014, January). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K130945 (CalPrest®). Retrieved September 15, 2011 from http://www.accessdata.fda.gov.
Winifred S. Hayes, Inc. Medical Technology Directory. (2017, July; last updated search July 2018). Fecal calprotectin assay for monitoring disease activity in Crohn disease. Retrieved October 26, 2018 from www.Hayesinc.com/subscribers. (70 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2017, June). Fecal calprotectin assay for monitoring postoperative recurrence of Crohn disease. Retrieved December 7, 2017 from www.Hayesinc.com/subscribers. (53 articles and/or guidelines reviewed)
Zhuge, Y., Huang, Q.P., Li, Q., & Wang, J.S. (2016). Fecal calprotectin for predicting relapse and activity in patients with Crohn’s disease: a meta-analysis. Euroasian Journal of Hepato-Gastroenterology, 6 (2), 116-124. (Level 2 evidence)
ORIGINAL EFFECTIVE DATE: 1/14/2012
MOST RECENT REVIEW DATE: 1/10/2019
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