BlueCross BlueShield of Tennessee Medical Policy Manual

Fecal Calprotectin Testing

DESCRIPTION

Fecal calprotectin is a calcium- and zinc-binding protein that is a potential indicator of intestinal inflammation. Fecal calprotectin testing (e.g., PhilCal®, CalPrest®, CalPrest®NG) has been proposed as a noninvasive test to diagnose inflammatory bowel disease (IBD), Crohn’s disease, and ulcerative colitis. A fecal calprotectin level of less than 50 ug/g is suggestive of a low likelihood of inflammatory bowel disease. Other potential uses are to differentiate inflammatory bowel disease (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 individuals with IBD and as a marker of relapse.

POLICY

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION 

There is a lack of evidence to support fecal calprotectin testing for the management and surveillance of inflammatory bowel disease.

SOURCES

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. (1:2019). Fecal Calprotectin Testing (2.04.69). Retrieved May 14, 2019 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. (2017). Faecal calprotectin diagnostic tests for inflammatory diseases of the bowel. Retrieved May 15, 2019 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; last updated search June 2018). Fecal calprotectin assay for monitoring postoperative recurrence of Crohn disease. Retrieved May 15, 2019 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:  9/30/2019  

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