Abstract
Objectives
Faecal calprotectin (f-Cal) and faecal haemoglobin (f-Hb) are important tests for evaluation of gastrointestinal disease. Samples for measurement of f-Hb are taken by the patient directly into a specimen collection device containing stabilising buffer, which can be placed directly onto the analyser in the laboratory. Samples for f-Cal are usually sent in screw top pots and often require time-consuming extraction procedures prior to analysis. OC-FCa calprotectin is a new assay which uses the same specimen collection device and analyser as our current f-Hb assay. Analytical evaluation has already shown it to perform well but to have a positive bias. This study was a clinical evaluation to investigate the diagnostic test performance and cut-off suitable for its use in the diagnosis of IBD.
Methods
OC-FCa calprotectin was measured in a convenience sample of 603 patients in whom f-Hb had been requested and was found to be ≥10 μg/g. Clinical outcomes were obtained from notes, radiological reports and endoscopy and histology reports.
Results
A total of 425 patients completed clinical investigations; IBD was diagnosed in 49 and other colorectal pathology in 161. Median f-Cal in patients with IBD was 1,660 μg/g, significantly different (p<0.01) from those with other colorectal pathology (192 μg/g) or normal findings (157 μg/g). ROC curve analysis showed AUC of 0.898 with sensitivity of 91.8% and specificity of 79.3% at a cut-off of 600 μg/g.
Conclusions
The new OC-FCa calprotectin assay performed well for the diagnosis of IBD using a cut-off of 600 μg/g.
Acknowledgments
We would like to thank Mast Diagnostics Division (Bootle, UK) and Eiken Chemical Co (Tokyo, Japan) for supplying reagents for calprotectin analysis and James Boston and Wahida IslamJohi for help with sample analysis.
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Research funding: None declared.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Not applicable.
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Ethical approval: The local Institutional Review Board deemed the study exempt from review.
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