Diagnostic Tests

What Physicians Need to Know

Fecal Calprotectin for the Evaluation of Inflammatory Bowel Disease

 

Am Fam Physician. 2021 Sep ;104(2):303-304.

Calprotectin is a protein expressed by neutrophils. The presence of fecal calprotectin is a sensitive indicator of gastrointestinal inflammation, with higher levels representing more inflammation. The U.S. Food and Drug Administration has approved the use of fecal calprotectin testing to aid in the diagnosis of inflammatory bowel disease (IBD) in adults and children presenting with gastrointestinal symptoms, and differentiating IBD from irritable bowel syndrome.1

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TestIndicationPopulationCost*

Fecal calprotectin

Diagnosis of inflammatory bowel disease

Patients with symptoms suggestive of inflammatory bowel disease vs. irritable bowel syndrome

$19.63


*—Payment rate according to the 2021 Centers for Medicare and Medicaid Services clinical laboratory fee schedule.5

TestIndicationPopulationCost*

Fecal calprotectin

Diagnosis of inflammatory bowel disease

Patients with symptoms suggestive of inflammatory bowel disease vs. irritable bowel syndrome

$19.63


*—Payment rate according to the 2021 Centers for Medicare and Medicaid Services clinical laboratory fee schedule.5

Accuracy

The manufacturer of the fecal calprotectin assay proposes a diagnostic threshold of greater than 50 mcg per g for the diagnosis of IBD. A systematic review of 19 diagnostic accuracy studies, which included 5,032 patients older than 16 years, examined the diagnostic performance of a fecal calprotectin assay compared with the reference standard of diagnostic colonoscopy. The pooled sensitivity and specificity for IBD were 0.88 (95% CI, 0.83 to 0.92) and 0.80 (95% CI, 0.69 to 0.88), respectively.2

In two prospective cohorts of children in the Netherlands with chronic diarrhea, recurring abdominal pain, or both, fecal calprotectin testing was compared with one of two reference standards: endoscopy or 12 months of clinical follow-up without an IBD diagnosis.3 The standard of clinical follow-up was added by the authors of the study because of concerns that performing an invasive procedure in a large number of children with a low likelihood of organic gastrointestinal disease would be unethical. In a group of 114 patients initially seen in primary care, 13 tested positive using a calprotectin cutoff of greater than 50 mcg per g (although none of them had IBD), yielding a specificity of 0.87 (95% CI, 0.80 to 0.92). In 85 patients referred to

Address correspondence to Carl Bryce, MD, FAAFP, at carl.bryce@abrazohealth.com. Reprints are not available from the authors.

Author disclosure: No relevant financial affiliations.

References

show all references

1. U.S. Food and Drug Administration. Title 21, volume 8. Part 866—immunology and microbiology devices, subpart F— immunological test systems, sec. 866.5180 fecal calprotectin immunological test system. April 1, 2020. Accessed February 18, 2021. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=866.5180...

2. Petryszyn P, Staniak A, Wolosianska A, et al. Faecal calprotectin as a diagnostic marker of inflammatory bowel disease in patients with gastrointestinal symptoms: meta-analysis. Eur J Gastroenterol Hepatol. 2019;31(11):1306–1312.

3. Holtman GA, Lisman-van Leeuwen Y, Kollen BJ, et al. Diagnostic accuracy of fecal calprotectin for pediatric inflammatory bowel disease in primary care: a prospective cohort study. Ann Fam Med. 2016;14(5):437–445.

4. Van de Vijver E, Heida A, Ioannou S, et al.; CACATU CONSORTIUM. Test strategies to predict inflammatory bowel disease among children with nonbloody diarrhea. Pediatrics. 2020;146(2):e20192235.

5. Centers for Medicare and Medicaid Services. 21CLABQ1. Item #83993. Accessed February 26, 2021. https://www.cms.gov/medicaremedicare-fee-service-paymentclinicallabfeeschedclinical-laboratory-fee-schedule-files/21clabq1

6. Yang Z, Clark N, Park K T. Effectiveness and cost-effectiveness of measuring fecal calprotectin in diagnosis of inflammatory bowel disease in adults and children. Clin Gastroenterol Hepatol. 2014;12(2):253–262.e2.

This series is coordinated by Kenny Lin, MD, MPH, deputy editor.

A collection of Diagnostic Tests published in AFP is available at https://www.aafp.org/afp/diagnostic.

 

 

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