Clinical evaluation of the OC-Sensor Pledia calprotectin assay
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Juozas Butenas
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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© 2022 Walter de Gruyter GmbH, Berlin/Boston
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Artikel in diesem Heft
- Frontmatter
- Editorial
- Measuring FGF23 in clinical practice: dream or reality?
- Reviews
- Fibroblast growth factor 23: translating analytical improvement into clinical effectiveness for tertiary prevention in chronic kidney disease
- Pursuing appropriateness of laboratory tests: a 15-year experience in an academic medical institution
- General Clinical Chemistry and Laboratory Medicine
- Moving average quality control of routine chemistry and hematology parameters – a toolbox for implementation
- Practical application of European biological variation combined with Westgard Sigma Rules in internal quality control
- Total bilirubin assay differences may cause inconsistent treatment decisions in neonatal hyperbilirubinaemia
- Early predictors of abnormal MRI patterns in asphyxiated infants: S100B protein urine levels
- Interlaboratory comparison study of immunosuppressant analysis using a fully automated LC-MS/MS system
- Analytical evaluation and bioclinical validation of new aldosterone and renin immunoassays
- Improving clinical performance of urine sediment analysis by implementation of intelligent verification criteria
- Clinical evaluation of the OC-Sensor Pledia calprotectin assay
- Serous body fluid evaluation using the new automated haematology analyser Mindray BC-6800Plus
- Analysis of cryoproteins with a focus on cryofibrinogen: a study on 103 patients
- Reference Values and Biological Variations
- Within-subject biological variation estimates using an indirect data mining strategy. Spanish multicenter pilot study (BiVaBiDa)
- Short-term biological variation of serum glial fibrillary acidic protein
- Reference ranges for GDF-15, and risk factors associated with GDF-15, in a large general population cohort
- Serum GFAP – reference interval and preanalytical properties in Danish adults
- Determination of pediatric reference limits for 10 commonly measured autoantibodies
- Hematology and Coagulation
- Arterial and venous blood sampling is equally applicable for coagulation and fibrinolysis analyses
- Infectious Diseases
- Free urinary sialic acid levels may be elevated in patients with pneumococcal sepsis
- Letters to the Editor
- Thyroid stimulating hormone: biased estimate of allowable bias
- Letter to the Editor relating to Clin Chem Lab Med 2022;60(9):1365–72
- Reply to the Letter of Sun et al. [1] relating to Clin Chem Lab Med 2022;60(9):1365–72
- Prognostic significance of smudge cell percentage in chronic lymphocytic leukemia. Facts or artifacts? Methodological considerations and literature review
- Detection of a monoclonal component after pediatric liver transplantation: a case report
- Reporting magnesium critical results: clinical impact on pregnant women and neonates
- Congress Abstracts
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