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FeedbackQuantitative Chemiluminescent Immunoassay (CLIA)
- Aids in differentiation of IBD from IBS and other functional disorders of the GI system
- Aids in monitoring IBD and prediction of relapse
Inflammatory bowel disease (IBD) represents a spectrum of chronic disorders that affect the gastrointestinal (GI) tract. Crohn disease (CD) and ulcerative colitis (UC) are the major IBD disorders. Fecal calprotectin is a marker of gut inflammation with good sensitivity for detecting IBD. Fecal lactoferrin, an iron-binding protein, is another useful marker of intestinal inflammation in IBD, but more clinical evidence is available for fecal calprotectin.
Disease Overview
Prevalence
IBD: 286/100,000 in United States
Physiology
- Calprotectin is a calcium-binding protein and accounts for 60% of soluble protein in neutrophils
- Calprotectin concentration in feces is proportional to the level of inflammation in patients with UC ; the relationship is more variable in patients with CD
- Calprotectin is stable in stool samples
Diagnostic Issues
- IBD symptoms may be vague and similar to those of irritable bowel syndrome (IBS) (eg, diarrhea, abdominal pain)
- IBS is much more prevalent than IBD
- Differentiation of IBD from IBS may require invasive procedures
- Calprotectin testing may be useful as a screen for differentiating IBS and IBD, reducing the necessity of invasive procedures
Monitoring Issues
- Monitoring by endoscopy is invasive
- Calprotectin measurement can be used to help differentiate quiescent from active IBD
- Mucosal healing is associated with sustained remission and is the goal of IBD treatment
- Calprotectin levels correlate with endoscopic scoring systems that are used to assess mucosal healing and may be useful in evaluating mucosal healing
Test Interpretation
Clinical Validation
Screening performance for IBD
- Sensitivity: 93% in adults; 92% in children
- Specificity: 96% in adults; 76% in children
- More sensitive and specific than serum inflammatory markers
- Individuals with high pretest probability of IBD (>75%) should be referred directly to endoscopy due to the risk of false-negative calprotectin results
- Screening for elevated fecal calprotectin in individuals with low pretest probability for IBD may result in cost savings by reducing need for unnecessary procedures
- Confirm positive results by endoscopy and follow negative result clinically
Results
| Results | Range | Clinical Significance |
|---|---|---|
|
Normal |
≤50 μg/g |
Likely to rule out IBD in adults with <75% prior probability |
|
Borderline |
51-120 μg/g |
Reevaluation in 4-6 weeks is recommended |
|
Abnormal |
≥121 μg/g |
Supports diagnosis of IBD |
Limitations
- Calprotectin is not specific for IBD and is also elevated in:
- GI infections
- Colorectal cancer
- Celiac disease
- Mild elevations may be seen with nonsteroidal anti-inflammatory drug or aspirin use
- Calprotectin concentration alone is not diagnostic for IBD
- Calprotectin does not distinguish celiac disease from UC
- Results may fluctuate as disease activity fluctuates
- GI bleeding can cause mild increases in fecal calprotectin concentrations
- Concentrations of fecal biomarkers may vary in different stool samples from a single patient
References
-
29126502
Yu YR, Rodriguez R. Clinical presentation of Crohn's, ulcerative colitis, and indeterminate colitis: aymptoms, extraintestinal manifestations, and disease phenotypes. Semin Pediatr Surg. 2017;26(6):349-355.
-
29610508
Lichtenstein GR, Loftus EV, Isaacs KL, et al. ACG clinical guideline: management of Crohn's disease in adults. Am J Gastroenterol. 2018;113(4):481-517.
-
30840605
Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114(3):384-413.
-
30881901
Georgy M, Negm Y, El-Matary W. Quality improvement in healthcare for patients with inflammatory bowel disease. Transl Pediatr. 2019;8(1):77-82.
-
15710984
Costa F, Mumolo MG, Ceccarelli L, et al. Calprotectin is a stronger predictive marker of relapse in ulcerative colitis than in Crohn's disease. Gut. 2005;54(3):364-368.
-
20634346
van Rheenen PF, Van de Vijver E, Fidler V. Faecal calprotectin for screening of patients with suspected inflammatory bowel disease: diagnostic meta-analysis. BMJ. 2010;341:c3369.
-
24231644
Levine A, Koletzko S, Turner D, et al. ESPGHAN revised porto criteria for the diagnosis of inflammatory bowel disease in children and adolescents. J Pediatr Gastroenterol Nutr. 2014;58(6):795-806.
-
23883663
Yang Z, Clark N, Park KT. 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.
-
25793326
Calafat M, Cabré E, Mańosa M, et al. High within-day variability of fecal calprotectin levels in patients with active ulcerative colitis: what is the best timing for stool sampling? Inflamm Bowel Dis. 2015;21(5):1072-1076.