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Utility of faecal calprotectin in inflammatory bowel disease (IBD): what cut-offs should we apply?
A Dhaliwal1, Z Zeino1, C Tomkins2
1Department of Gastroenterology, University Hospitals Coventry and Warwickshire, Coventry , UK.
Insights
Faecal calprotectin (FC) testing effectively excludes inflammatory bowel disease (IBD) with 87% negative predictive value. Elevated FC levels can indicate IBD, while levels below 250 μg/g suggest remission.
Area of Science:
- Gastroenterology
- Clinical Diagnostics
- Biomarker Research
Background:
- Faecal calprotectin (FC) is a neutrophil-derived protein used to differentiate inflammatory bowel disease (IBD) from irritable bowel syndrome (IBS) due to overlapping symptoms.
- Non-invasive FC testing aids in distinguishing between functional gastrointestinal disorders and inflammatory conditions.
Purpose of the Study:
- To establish FC cut-offs for excluding IBD and determining remission in IBD patients.
- To assess the stability of FC under various storage conditions (time and temperature).
- To compare the performance of three enzyme-linked immunosorbent assay (ELISA) kits for FC measurement.
Main Methods:
- A cohort of 311 patients with altered bowel habits (144 IBS, 148 IBD, 19 other) underwent FC testing.
- FC stability was evaluated after extraction and freezing for up to 2.5 months.
- Three ELISA kits (Buhlmann, PhiCal v1, PhiCal v2) were used to measure FC levels.
Main Results:
- The PhiCal v2 kit demonstrated 88% sensitivity and 78% specificity for distinguishing IBS from IBD at a 50 μg/g cut-off, with an 87% negative predictive value.
- For IBD patients, FC levels < 250 μg/g indicated remission with 90% sensitivity and 76% specificity.
- FC remained stable when frozen for up to 2.5 months, and good correlation was observed between the Buhlmann and PhiCal v2 assays (r² = 0.95).
Conclusions:
- Faecal calprotectin testing offers a high negative predictive value (87%) for excluding IBD.
- FC cut-offs < 250 μg/g demonstrate 90% sensitivity in identifying IBD remission.
- FC is stable under frozen conditions, and the tested ELISA kits provide comparable results.
Background:
Faecal calprotectin (FC), a cytosolic protein released by neutrophils (S100 family) in response to inflammation, is a simple, non-invasive test that can be used to differentiate irritable bowel syndrome (IBS) with inflammatory bowel disease (IBD), where there can be considerable symptom overlap.
Aims And Methods:
The aims of the study were (1) to be able to predict the ability of FC to exclude IBD and determine cut-offs when in remission, (2) to investigate the effects of time and temperature on stability of FC and (3) compare three ELISA kits to measure FC: Buhlmann, PhiCal v1 and PhiCal v2. A total of 311 patients with altered bowel habit were tested for FC; 144 with IBS, 148 with IBD and 19 with other organic causes.
Results:
Sensitivity and specificity of FC (with PhiCal v2 kit) to distinguish between functional disorder (IBS) and IBD using cut-off 50 μg/g were 88% and 78%, respectively, with a negative predictive value of 87%. Area under the receiver operating curve was 0.84 (CI 0.78 to 0.90). For those with IBD, FC values below 250 μg/g corresponded with remission of disease with a sensitivity and specificity of 90% and 76%, respectively. Area under the receiver operating curve was 0.93 (CI 0.89 to 0.97). FC was stable once extracted and frozen for up to 2.5 months. Pearson correlation was good between Buhlmann assay and PhiCal v2 (r2 = 0.95).
Conclusions:
FC has up to 87% negative predictive value to exclude IBD, and cut-offs less than 250 μg/g had 90% sensitivity to determine remission in IBD. Once frozen, FC is stable and the ELISA monoclonal plates were broadly comparable.
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