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Faecal calprotectin: comparative study of the Quantum Blue rapid test and an established ELISA method

  • Liselotte Coorevits , Filip J. Baert and Hilde J.M. Vanpoucke EMAIL logo
Published/Copyright: September 22, 2012
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 51 Issue 4

Abstract

Background: Faecal calprotectin is a non-invasive marker for neutrophilic intestinal inflammation. It can be used in the differential diagnosis between functional and organic bowel disease. Moreover, it correlates with endoscopic organic bowel disease activity. The objective of this study is to evaluate a recently launched quantitative immunochromatographic point-of-care test: Quantum Blue Calprotectin (Bühlmann Laboratories AG, Schönenbuch, Switzerland) in comparison to an established ELISA method (Bühlmann Laboratories AG).

Methods: We included 142 samples, either archived (–80°C) faecal extracts or fresh routine samples. Both the normal range cartridges as well as the high range cartridge from the point-of-care test were used. The ELISA was compared with the point-of-care test and the optimal the point-of-care test cut-off values were searched for using Microsoft® Excel 2002 and MedCalc Software version 10.0.0.0 (Mariakerke, Belgium).

Results: In the method comparison a determination coefficient (R2) of 0.89 was found. The Passing Bablok regression analysis showed a significant deviation from linearity (y=–40.8+1.0x). The use of a cut-off value of 30 μg/g faeces and a grey zone of 30–110 μg/g faeces resulted in the best agreement between the ELISA interpretation and the point-of-care test interpretation, with 89.4% (127/142) agreement and 10.6% (15/142) mismatches.

Conclusions: We may conclude that the point-of-care test can serve as a reliable alternative to the time consuming ELISA in the differential diagnosis between functional and organic bowel disease. Furthermore, it seems to be reliable in the follow-up of inflammatory bowel disease patients.

Keywords: biomarker; calprotectin; faeces; inflammatory bowel disease; point-of-care test
Corresponding author: Clin. Biologist Hilde J.M. Vanpoucke, Clinical Laboratory HHRM, Ardooisesteenweg 276, 8800 Roeselare, Belgium, Phone: +32 56522322, Fax: +32 51237974

The authors would like to thank Mrs. Kristel Engelen from Alere for providing us with the POCT kits. We would also like to thank Prof. Dr. Alain Verstraete (Ghent University, Department of Clinical Chemistry, Microbiology and Immunology) for the interesting scientific discussions and his critical revision of the article.

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 funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

References

1. Konikoff MR, Denson LA. Role of faecal calprotectin as a biomarker of intestinal inflammation in inflammatory bowel disease. Inflamm Bowel Dis 2006;12:524–34.10.1097/00054725-200606000-00013Search in Google Scholar

2. Costa F, Mumolo MG, Bellini M, Romano MR, Ceccarelli L, Arpe P, et al. Role of faecal calprotectin as non-invasive marker of intestinal inflammation. Dig Liver Dis 2003;35:642–7.10.1016/S1590-8658(03)00381-5Search in Google Scholar

3. Lewis JD. The utility of biomarkers in the diagnosis and therapy of inflammatory bowel disease. Gastroenterology 2011;140:1817–26.10.1053/j.gastro.2010.11.058Search in Google Scholar PubMed PubMed Central

4. van Rheenen PF, Van de Vijver E, Fidler V. Faecal calprotectin for screening of patients with suspected inflammatory bowel disease: diagnostic meta-analysis. Br Med J 2010; 341:c3369.10.1136/bmj.c3369Search in Google Scholar PubMed PubMed Central

5. Keohane J, O’Mahony C, O’Mahony L, O’Mahony S, Quigley EM, Shanahan F. Irritable bowel syndrome-type symptoms in patients with inflammatory bowel disease: a real association or reflection of occult inflammation. Am J Gastroenterol 2010;105:1789–94.10.1038/ajg.2010.156Search in Google Scholar PubMed

6. Carroccio A, Iacono G, Cottone M, Di Prima L, Cartabellotta F, Cavataio F, et al. Diagnostic accuracy of faecal calprotectin assay in distinguishing organic causes of chronic diarrhea from irritable bowel syndrome: a prospective study in adults and children. Clin Chem 2003;49:861–7.10.1373/49.6.861Search in Google Scholar PubMed

7. Tibble JA, Sigthorsson G, Bridger S, Fagerhol MK, Bjarnason I. Surrogate markers of intestinal inflammation are predictive of relapse in patients with inflammatory bowel disease. Gastroenterology 2000;119:15–22.10.1053/gast.2000.8523Search in Google Scholar PubMed

8. Røseth AG, Aadland E, Grzyb K. Normalization of faecal calprotectin: a predictor of mucosal healing in patients with inflammatory bowel disease. Scand J Gastroenterol 2004;39:1017–20.10.1080/00365520410007971Search in Google Scholar PubMed

9. Tibble JA, Bjarnason I. Faecal calprotectin as an index of intestinal inflammation. Drugs Today (Barc) 2001;37:85–96.10.1358/dot.2001.37.2.614846Search in Google Scholar PubMed

10. Quantum Blue® Calprotectin Normal Range Quantitative Lateral Flow Assay LF-CAL20 package insert (2010-11-10).Search in Google Scholar

11. Quantum Blue® Calprotectin High Range Quantitative Lateral Flow Assay LF-CHR20 package insert (2011-04-11).Search in Google Scholar

12. Gisbert JP, McNicholl AG. Clinical review: questions and answers on the role of faecal calprotectin as a biological marker in inflammatory bowel disease. Dig Liver Dis 2009;41:56–66.http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=000263141300010&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=b7bc2757938ac7a7a821505f8243d9f310.1016/j.dld.2008.05.008Search in Google Scholar PubMed

13. Wassell J, Wallage M, Brewer E. Evaluation of the Quantum Blue rapid test for faecal calprotectin. Ann Clin Biochem 2012;49:55–8.http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=000299984500008&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=b7bc2757938ac7a7a821505f8243d9f3Search in Google Scholar

14. Dolci A, Panteghini M. Comparative study of a new quantitative rapid test with an established ELISA method for faecal calprotectin. Clin Chim Acta 2012;413:350–1.http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=000298462400065&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=b7bc2757938ac7a7a821505f8243d9f310.1016/j.cca.2011.09.030Search in Google Scholar PubMed

15. Husebye E, Tøn H, Johne B. Biological variability of faecal calprotectin in patients referred for colonoscopy without colonic inflammation or neoplasm. Am J Gastroenterol 2001;96: 2683–7.10.1016/S0002-9270(01)02688-0Search in Google Scholar

16. Jensen MD, Kjeldsen J, Nathan T. Faecal calprotectin is equally sensitive in Crohn’s disease affecting the small bowel and colon. Scand J Gastroenterol 2011;46:694–700.http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=000290492400007&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=b7bc2757938ac7a7a821505f8243d9f310.3109/00365521.2011.560680Search in Google Scholar PubMed

17. Vestergaard TA, Nielsen SL, Dahlerup JF, Hornung N. Faecal calprotectin: assessment of a rapid test. Scand J Clin Lab Invest 2008;68:343–7.http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=000257471700012&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=b7bc2757938ac7a7a821505f8243d9f3Search in Google Scholar

18. Otten CM, Kok L, Witteman BJ, Baumgarten R, Kampman E, Moons KG, et al. Diagnostic performance of rapid tests for detection of faecal calprotectin and lactoferrin and their ability to discriminate inflammatory from irritable bowel syndrome. Clin Chem Lab Med 2008;46:1275–80.http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=000259929300012&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=b7bc2757938ac7a7a821505f8243d9f3Search in Google Scholar

19. Damms A, Bischoff SC. Validation and clinical significance of a new calprotectin rapid test for the diagnosis of gastrointestinal diseases. Int J Colorectal Dis 2008;23:985–92.http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=000258884200010&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=b7bc2757938ac7a7a821505f8243d9f310.1007/s00384-008-0506-0Search in Google Scholar PubMed

20. Elkjaer M, Burisch J, Voxen Hansen V, Deibjerg Kristensen B, Slott Jensen JK. A new rapid home test for faecal calprotectin in ulcerative colitis. Aliment Pharmacol Ther 2010;31: 323–30.10.1111/j.1365-2036.2009.04164.xSearch in Google Scholar
Received: 2012-06-18
Accepted: 2012-08-19
Published Online: 2012-09-22
Published in Print: 2013-04-01

©2013 by Walter de Gruyter Berlin Boston

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https://doi.org/10.1515/cclm-2012-0386
Keywords for this article
biomarker; calprotectin; faeces; inflammatory bowel disease; point-of-care test

Articles in the same Issue

  1. Letters to the Editor
  2. Missing agreement between the two IMMULITE® PSA assays
  3. “Cerebrovascular stressing”: dipyridamole-induced S100B elevation predicts ischemic cerebrovascular events
  4. Discrepancy in lamellar body counts (LBCs) between the Sysmex XE-2100 and Sysmex XT-2000i instruments
  5. Interphase fluorescent in situ hybridization detection of the 7q11.23 chromosomal inversion in a clinical laboratory: automated versus manual scoring
  6. Adrenocorticotropic hormone stability in preanalytical phase depends on temperature and proteolytic enzyme inhibitor
  7. The impact on costs and efficiency of reducing the number of collected tubes
  8. Improved software on the Sysmex XE-5000 BF mode for counting leukocytes in cerebrospinal fluid
  9. First trimester placental growth factor and soluble fms-like tyrosine kinase 1 are significantly related to PAPP-A levels
  10. Preliminary evaluation of complete blood cell count on Mindray BC-6800
  11. Rational use of laboratory tests: albuminuria
  12. Masthead
  13. Masthead
  14. Editorials
  15. Fifty years of CCLM – invitation to join us for a reception in Milan
  16. Personalized (laboratory) medicine: a bridge to the future
  17. PSA, PCA3 and the phi losophy of prostate cancer management
  18. Reviews
  19. Gender medicine: a task for the third millennium
  20. Evaluation of [−2] proPSA and Prostate Health Index (phi) for the detection of prostate cancer: a systematic review and meta-analysis
  21. Harmonization in laboratory medicine: the complete picture
  22. Opinion Papers
  23. Glycemic control in the clinical management of diabetic patients
  24. Time for a conceptual shift in assessment of internal quality control for whole blood or cell-based testing systems? An evaluation using platelet function and the PFA-100 as a case example
  25. Guidelines and Recommendations
  26. A position paper of the EFLM Committee on Education and Training and Working Group on Distance Education Programmes/E-Learning: developing an e-learning platform for the education of stakeholders in laboratory medicine
  27. General Clinical Chemistry and Laboratory Medicine
  28. A novel weighted cumulative delta-check method for highly sensitive detection of specimen mix-up in the clinical laboratory
  29. Identification and quantification of hemoglobins in whole blood: the analytical and organizational aspects of Capillarys 2 Flex Piercing compared with agarose electrophoresis and HPLC methods
  30. Determination of the fatty acid profile of neutral lipids, free fatty acids and phospholipids in human plasma
  31. Urinary iodine concentrations of pregnant women in Ukraine
  32. Delay in the measurement of eosin-5′-maleimide (EMA) binding does not affect the test result for the diagnosis of hereditary spherocytosis
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