Evaluation of a faecal calprotectin method using the OC-SENSOR PLEDIA
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Shane O’Driscoll
,
Carolyn Piggott
und
Sally C. Benton
Abstract
Objectives
The National Institute for Health and Care Excellence recommends faecal calprotectin (f-cal) to help differentiate inflammatory bowel diseases from irritable bowel syndrome. Faecal samples for calprotectin have historically been collected at home by patients into screw-top pots and sent to laboratories where calprotectin is extracted and analysed. Faecal haemoglobin (f-Hb) samples are collected at home into specific collection devices containing stabilising buffer. We evaluated the OC-FCa method for f-cal, developed by Eiken Chemical Co., Ltd. (Japan) that uses the same collection device and analyser as f-Hb.
Methods
OC-FCa was assessed for limit of blank (LOB), limit of detection (LOD), limit of quantification (LOQ), within and between-run imprecision, linearity, prozone, recovery and carryover. A method comparison against the BÜHLMANN fCAL® turbo (BÜHLMANN Laboratories AG, Switzerland) was performed using patient samples and EQA.
Results
The LOB was 3 µg calprotectin/g faeces (µg/g), LOD 8 μg/g and LOQ 20 μg/g. Within and between-run imprecision was <5%; linearity was good (R2 > 0.99); prozone was appropriately detected; recovery was 99.6%; no observed carryover. OC-FCa showed a strong positive bias compared with BÜHLMANN fCAL® turbo (Z=−5.3587, p < 0.001). When categorised using our local pathway, which interprets calprotectin concentrations and need for further investigation, Cohen’s Kappa demonstrates substantial agreement at <50 μg/g (κ=0.80) and >150 μg/g (κ=0.63) and fair agreement (κ=0.22) in the borderline category 50–150 μg/g.
Conclusions
The OC-FCa method performed well in the evaluation. With the lack of standardisation for f-cal a clinical study is required to evaluate the positive bias and establish suitable cut-off levels.
Acknowledgments
We would like to thank Eiken Chemical Co., Ltd., Tokyo, Japan and Mast Diagnostics Division, Bootle, Merseyside, UK for supplying the analysers and consumables, and UK NEQAS for providing materials for assessment.
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Research funding: None declared.
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Author contribution: 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: Informed consent was obtained from all individuals included in this study.
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Ethical approval: The local Institutional Review Board deemed the study exempt from review.
References
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© 2022 Walter de Gruyter GmbH, Berlin/Boston
Artikel in diesem Heft
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- EFLM Paper
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- Determination of individual bile acids in acute respiratory distress syndrome reveals a specific pattern of primary and secondary bile acids and a shift to the acidic pathway as an adaptive response to the critical condition
- Evaluation of a faecal calprotectin method using the OC-SENSOR PLEDIA
- Reference Values and Biological Variations
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Artikel in diesem Heft
- Frontmatter
- Reviews
- Statistics in diagnostic medicine
- Interferences in immunoassays: review and practical algorithm
- EFLM Paper
- The value proposition of integrative diagnostics for (early) detection of cancer. On behalf of the EFLM interdisciplinary Task and Finish Group “CNAPS/CTC for early detection of cancer”
- General Clinical Chemistry and Laboratory Medicine
- Benchmarking medical laboratory performance: survey validation and results for Europe, Middle East, and Africa
- Pre-analytical stability of serum biomarkers for neurological disease: neurofilament-light, glial fibrillary acidic protein and contactin-1
- Filling in the GAPS: validation of anion gap (AGAP) measurement uncertainty estimates for use in clinical decision making
- Implementation and challenges of portable blood gas measurements in air medical transport
- Calculation of the estimated glomerular filtration rate using the 2021 CKD-EPI creatinine equation and whole blood creatinine values measured with Radiometer ABL 827 FLEX
- Dubiously increased FT4 and FT3 levels in clinically euthyroid patients: clinical finding or analytical pitfall?
- Two co-inherited hemoglobin variants revealed by capillary electrophoresis during quantification of glycated hemoglobin
- Determination of individual bile acids in acute respiratory distress syndrome reveals a specific pattern of primary and secondary bile acids and a shift to the acidic pathway as an adaptive response to the critical condition
- Evaluation of a faecal calprotectin method using the OC-SENSOR PLEDIA
- Reference Values and Biological Variations
- Reference intervals for Sysmex XN hematological parameters as assessed in the Dutch Lifelines cohort
- Cardiovascular Diseases
- High incidence of discrepancies in new Siemens assay – a comparison of cardiac troponin I assays
- Infectious Diseases
- Effect of BNT162b2 booster dose on anti-SARS-CoV-2 spike trimeric IgG antibodies in seronegative individuals
- The role of neutralizing antibodies by sVNT after two doses of BNT162b2 mRNA vaccine in a cohort of Italian healthcare workers
- Continuous monitoring of SARS-CoV-2 seroprevalence in children using residual blood samples from routine clinical chemistry
- Prognostic significance of soluble CD25 in patients with sepsis: a prospective observational study
- Letters to the Editors
- Diagnostic accuracy of the ultrasensitive S-PLEX SARS-CoV-2 N electrochemiluminescence immunoassay
- Life-threatening autoimmune hemolytic anemia following mRNA COVID-19 vaccination: don’t be too prudent with the red gold
- CSF-interleukin 6 for early diagnosis of ventriculitis in a broad intensive care setting
- Clearance of macro-TSH from the circulation is slower than TSH
- Biological variation and reference change value as decision criteria in clinical use of tumor biomarkers. Are they really useful?
- Testing for anti-Müllerian hormone: analytical performances and usability of a point-of-care assay
- Diagnostic performance characteristics of the Quanta Flash Rheumatoid Factor assay in a consecutive Dutch patient cohort
- Trimester-specific reference values for the anticardiolipin antibody by chemiluminescence immunoassay in healthy pregnancy
- Congress Abstracts
- 4th National Point of Care Testing Symposium
