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Analytical and diagnostic performance of two automated fecal calprotectin immunoassays for detection of inflammatory bowel disease

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Published/Copyright: January 11, 2017
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 55 Issue 9

Abstract

Background:

We evaluated the (pre-)analytical and diagnostic performance of two automated fecal calprotectin (FC) immunoassays, Liaison® Calprotectin (Diasorin) on Liaison® XL and fCAL™ turbo (Bühlmann laboratories AG) on Cobas C501 (Roche Diagnostics), and compared it with our established Bühlmann ELISA method.

Methods:

Our study comprised 229 consecutive patients with clinical suspicion of inflammatory bowel disease (IBD).

Results:

All assay related stool extraction procedures showed excellent correlation with the established method, but the new stool extraction devices tend to give higher results as compared with stool weight methods. Both automated assays demonstrated good performance in terms of precision (CVt≤8.1%), accuracy (bias≤6.7%) and total error (≤16.4%). Method comparison with established enzyme linked immunosorbent assay (ELISA) showed good correlation (rs>0.925), but regression analysis showed significant proportional differences. Diagnostic performance characteristics with regard to diagnosis of IBD were good and in line with other reports. In addition, we were able to show that optimization of manufacturer’s cut-off and moreover, the introduction of a gray zone resulted in a significant increase of post-test probability.

Conclusions:

In conclusion, the newly developed stool extraction device protocols showed acceptable and comparable performance to the stool weight method. Overall, the automated Liaison® Calprotectin and fCAL™ turbo assay showed good analytical and diagnostic performance for detection of IBD.

Keywords: biomarker; calprotectin; Crohn’s disease; diagnostic performance; extraction; feces; immunoassay; inflammatory bowel disease; likelihood ratio; ulcerative colitis

Acknowledgments

The authors would like to thank all clinicians who took part in the study. We thank Diasorin and Alere – Bühlmann Laboratories AG for providing all kits. In addition, we are grateful to the laboratory technicians of General hospital AZ Delta Roeselare Menen for their most valuable efforts. Additionally, we are grateful to Prof. Dr. V. Stove of the Ghent University Hospital for the interesting scientific discussions.

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) 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.

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Received: 2016-9-6
Accepted: 2016-11-22
Published Online: 2017-1-11
Published in Print: 2017-8-28

©2017 Walter de Gruyter GmbH, Berlin/Boston

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  31. Letters to the Editor
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https://doi.org/10.1515/cclm-2016-0796
Keywords for this article
biomarker; calprotectin; Crohn’s disease; diagnostic performance; extraction; feces; immunoassay; inflammatory bowel disease; likelihood ratio; ulcerative colitis

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Mass spectrometry or immunoassay: est modus in rebus
  4. Reviews
  5. The use of liquid chromatography-tandem mass spectrometry for therapeutic drug monitoring of antibiotics in cancer patients
  6. Tackling serum folate test in European countries within the health technology assessment paradigm: request appropriateness, assays and health outcomes
  7. Genetics and Molecular Diagnostics
  8. Genetic diagnosis of α1-antitrypsin deficiency using DNA from buccal swab and serum samples
  9. General Clinical Chemistry and Laboratory Medicine
  10. Serum triglyceride measurements: the commutability of reference materials and the accuracy of results
  11. Variant peptide detection utilizing mass spectrometry: laying the foundations for proteogenomic identification and validation
  12. Evaluation of two fully automated immunoassay based tests for the measurement of 1α,25-dihydroxyvitamin D in human serum and comparison with LC-MS/MS
  13. Parallel diurnal fluctuation of testosterone, androstenedione, dehydroepiandrosterone and 17OHprogesterone as assessed in serum and saliva: validation of a novel liquid chromatography-tandem mass spectrometry method for salivary steroid profiling
  14. Determination of oxycodone and its major metabolites noroxycodone and oxymorphone by ultra-high-performance liquid chromatography tandem mass spectrometry in plasma and urine: application to real cases
  15. Identification and quantitation of phosphatidylethanols in oral fluid by liquid chromatography-tandem mass spectrometry
  16. Relationship between plasma and salivary melatonin and cortisol investigated by LC-MS/MS
  17. Paramagnetic micro-particles as a tool for rapid quantification of apixaban, dabigatran, edoxaban and rivaroxaban in human plasma by UHPLC-MS/MS
  18. Measurements of serum non-ceruloplasmin copper by a direct fluorescent method specific to Cu(II)
  19. The serum concentrations of leptin and MCP-1 independently predict low back pain duration
  20. Immunoassay screening in urine for synthetic cannabinoids – an evaluation of the diagnostic efficiency
  21. Cancer Diagnostics
  22. Study of kallikrein-related peptidase 6 (KLK6) and its complex with α1-antitrypsin in biological fluids
  23. Cardiovascular Diseases
  24. A candidate liquid chromatography mass spectrometry reference method for the quantification of the cardiac marker 1-32 B-type natriuretic peptide
  25. The natriuretic peptide MR-proANP predicts all-cause mortality and adverse outcome in community patients: a 10-year follow-up study
  26. CASZ1 loss-of-function mutation contributes to familial dilated cardiomyopathy
  27. Diabetes
  28. Evaluating new HbA1c methods for adoption by the IFCC and NGSP reference networks using international quality targets
  29. Infectious Diseases
  30. Analytical and diagnostic performance of two automated fecal calprotectin immunoassays for detection of inflammatory bowel disease
  31. Letters to the Editor
  32. Is fasting necessary for lipid profile determinations? Some considerations from the perspective of the clinical laboratory
  33. Precision of nonfasting lipid profiles should focus on clinical relevance rather than necessarily obtaining the least variation
  34. Triglyceride concentrations should be measured after elimination of free glycerol to exclude interindividual variations due to adiposity and fasting status
  35. Estimation of the reference interval for serum folate measured with assays traceable to the WHO International Standard
  36. Implausible elevation of peripheral thyroid hormones during therapy with a protein supplement
  37. Interference in Na+ measurements on the Siemens RAPIDPoint® 500 after nortriptyline intoxication: a case report
  38. Usefulness of maternal red cell antibodies to predict hemolytic disease of the fetus and newborn and significant neonatal hyperbilirubinemia: a retrospective study
  39. Improvement of the Sandell-Kolthoff reaction method (ammonium persulfate digestion) for the determination of iodine in urine samples
  40. Clinical use of targeted high-throughput whole-genome sequencing for a dengue virus variant
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