Comparison of two immunoassays for measurement of faecal calprotectin in detection of inflammatory bowel disease: (pre)-analytical and diagnostic performance characteristics
-
Matthijs Oyaert
,
Charlotte Trouvé
Abstract
Background: Symptoms of inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS) can overlap. Faecal calprotectin has recently been established to be a non-invasive marker for neutrophilic intestinal inflammation. We compared two devices for extraction of faecal calprotectin. Based on these results, two immunoassays for measurement of faecal calprotectin were evaluated.
Methods: Samples were extracted using the Thermo Fisher extraction device (Thermo Fisher Scientific) and Smart Pep extraction device (Roche Diagnostics) and measured with the EliA Calprotectin immunoassay (Thermo Fisher Scientific) on ImmunoCAP 250. The performance of both assays was investigated by enrolling 183 consecutive patients (79 males, 104 females; median age 32 years) with clinical suspicion of IBD. Faecal calprotectin was measured using a recently launched immunoassay, EliA Calprotectin in comparison with an established immunochomatographic point-of-care-test (POCT, Quantum Blue Calprotectin; Bühlmann). Results were compared with endoscopic and histological findings.
Results: The use of the Thermo Fisher extraction device resulted in an underestimation of faecal calprotectin concentrations, especially in liquid stool samples. IBD was diagnosed in 51/183 patients (27.9%) [Crohn’s disease (CD, n=37), ulcerative colitis (UC, n=14)]. After adjusting the optimal cut-off for detection of IBD using receiver operating curve analysis, a sensitivity of 94.1% and 90.2% and specificity of 87.9% and 90.9% for the EliA and POCT assay, respectively, were obtained.
Conclusions: The Thermo Fisher device is not reliable for extraction of faecal calprotectin. The performance characteristics of the EliA Calprotectin assay are statistically equivalent to the Bühlmann POCT.
We thank Thermo Fisher Scientific and Bühlmann Laboratories AG for the generous donation of the assays. We are grateful to the laboratory technicians of AZ St. Jan Brugge and AZ Delta Roeselare Menen for their most valuable efforts. Additionally, we are grateful to Prof. Dr. P. Vermeersch for the interesting scientific discussions.
Conflict of interest statement
Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article. Research support played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
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Articles in the same Issue
- Masthead
- Masthead
- Editorial
- Point of care testing: evolving scenarios and innovative perspectives
- Review
- Point-of-care testing: where is the evidence? A systematic survey
- Mini Review
- Vulnerability of point-of-care test reagents and instruments to environmental stresses: implications for health professionals and developers
- Opinion Paper
- Twenty-five years of idiopathic calcium nephrolithiasis: has anything changed?
- Genetics and Molecular Diagnostics
- Optimizing the purification and analysis of miRNAs from urinary exosomes
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- Extensive study of human insulin immunoassays: promises and pitfalls for insulin analogue detection and quantification
- Absorptive chemistry based extraction for LC-MS/MS analysis of small molecule analytes from biological fluids – an application for 25-hydroxyvitamin D
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- Reference change values to assess changes in concentrations of biomarkers of exposure in individuals participating in a cigarette-switching study
- Reference values of fetal serum β2-microglobulin in the Chinese: evaluation of its clinical usefulness
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- Gut neuroendocrine tumor blood qPCR fingerprint assay: characteristics and reproducibility
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- Is magnetic resonance imaging really innocent?
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- Evaluating the inappropriateness of repeated laboratory testing in a teaching hospital of South Italy
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