ecal Calprotectin Levels in Patients with Idiopathic Inflammatory Bowel Disease – Comparison of Two Commercial Tests
Authors:
K. Malíčková 1; I. Janatková 1; M. Bortlík 2,3; V. Komárek 2; M. Lukáš 1,2
Authors‘ workplace:
Ústav klinické biochemie a laboratorní diagnostiky VFN a 1. LF UK v Praze
1; Klinické a výzkumné centrum pro idiopatické střevní záněty ISCARE IVF a 1. LF UK v Praze
2; Ústav biologie a lékařské genetiky VFN a 1. LF UK v Praze
3
Published in:
Epidemiol. Mikrobiol. Imunol. 57, 2008, č. 4, s. 147-153
Overview
Background:
Fecal calprotectin test is a simple, non-invasive, rapid and inexpensive diagnostic tool allowing differentiation between GIT functional disorders and inflammatory conditions and relapse prediction in non-specific inflammatory bowel disease. In the last year, commercially available ELISA diagnostic kits, using either monoclonal or polyclonal antibodies against a heterodimeric complex, calprotectin, for the detection of fecal calprotectin, started to be marketed.
Objective:
To compare two ELISA kits for the detection of fecal calprotectin differing from each other in the used type of antibody (monoclonal versus polyclonal).
Material and Methods:
Two ELISA kits were assessed: Calprotectin ELISA (Bühlmann, Basel, Switzerland) using a monoclonal antibody against calprotectin and PhiCalTM Calprotectin ELISA (R-Biopharm, Darmstadt, Germany) using a polyclonal antibody against calprotectin. We analyzed fecal eluates from patients with Crohn’s disease (CD, n = 36) and ulcerous colitis (UC, n = 29) and from healthy controls (n = 98). Data were analyzed using software Statistica CZ 8.0 (Statsoft, Tulsa, USA) and measurement variability parameters (linearity, repeatability, stability) and test sensitivity and specificity were established and the methods were compared.
Results:
The two kits showed adequate accuracy (intra- and inter-assay variation < 10%). The dilution linearity test indicated superiority of the Calprotectin ELISA Bühlmann kit, in particular for high calprotectin levels. The results of the two methods showed good correlation: Pearson’s correlation coefficient r = 0,83, limit difference according to Bland-Altman plot ranged from 17% to 30%. Diagnostic sensivity rates were 79 % for the Calprotectin ELISA Bühlmann kit and 74 % for the Calprotectin ELISA R-Biopharm kit, the test specificity rates were 87 % and 84 %, respectively.
Conclusions:
Both of the tested kits have comparably good measurement parameters, the Bühlmann kit using monoclonal antibody against calprotectin showed higher sensitivity and specificity. In view of their availability, sensitivity and performance, the fecal calprotectin ELISA kits are helpful diagnostic tools for clinical practice.
Key words:
fecal calprotectin – idiopathic intestinal inflammation – ELISA – monoclonal antibody – polyclonal antibody.
Sources
1. Aadland, E., Fagerhol, M.K. Faecal calprotectin: a marker of inflammation throughout the intestinal tract. Eur J Gastroenterol Hepatol. 2002, 14, 823-825.
2. Amati, L., Passeri, M.E., Selicato, F. New insights into the biological and clinical significance of fecal calprotectin in inflammatory bowel disease. Immunopharmacol Immunotoxicol 2006, 28, 665-681.
3. Berni Canani, R., Terrin, G., Rapacciuolo, L. Faecal calprotectin as reliable non-invasive marker to assess the severity of mucosal inflammation in children with inflammatory bowel disease. Dig Liver Dis 2008, 40(7), 547-53.
4. Bland, J.M., Altman, D.G. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986, 1(8476), 307-310.
5. Bremner, A., Roked, S., Robinson, R. et al. Faecal calprotectin in children with chronic gastrointestinal symptoms. Acta Paediatr 2005, 94, 1855-1858.
6. Bunn, S.K., Bisset, W.M., Main, M.J. Fecal calprotectin as a measure of disease activity in childhood inflammatory bowel disease. Pediatr Gastroenterol Nutr. 2001, 32, 171-177.
7. Carroccio, A., Iacono, G., Cottone, M. et al. Diagnostic accuracy of fecal calprotectin assay in distinguishing organic causes of chronic diarrhea from irritable bowel syndrome: a prospective study in adults and children. Clin Chem 2003, 49, 861-867.
8. Costa, F., Mumolo, M.G., Bellini, M. et al. Role of faecal calprotectin as non-invasive marker of intestinal inflammation. Dig Liver Dis 2003, 35, 642-647.
9. Costa, F., Mumolo, M.G., Ceccarelli, L. et al. Calprotectin is a stronger predictive marker of relapse in ulcerative colitis than in Crohn’s disease. Gut 2005, 54, 364-368.
10. De Jong, N.S., Leach, S.T., Day, A.S. Fecal S100A12: a novel noninvasive marker in children with Crohn’s disease. Inflamm Bowel Dis 2006, 12, 566-572.
11. D’Inca, R., Dal Pont, E., Di Leo, V. et al. Calprotectin and lactoferrin in the assessment of intestinal inflammation and organic disease. Int J Colorectal Dis 2007, 22, 429-437.
12. Eng, J. Receiver operating characteristic analysis: a primer. Acad Radiol 2005, 12(7), 909-916.
13. Fagerberg, U.L., Loof, L., Lindholm, J. Fecal calprotectin: a quantitative marker of colonic inflammation in children with inflammatory bowel disease. J Pediatr Gastroenterol Nutr 2007, 45, 414-420.
14. Fagerberg, U.L., Loof, L., Merzoug, R.D. et al. Fecal calprotectin levels in healthy children studied with an improved assay. J Pediatr Gastroenterol Nutr 2003, 37, 468-472.
15. Fagerberg, U.L., Loof, L., Myrdal, U. Colorectal inflammation is well predicted by fecal calprotectin in children with gastrointestinal symptoms. J Pediatr Gastroenterol Nutr 2005, 40, 450-455.
16. Fagerhol, M.K. Calprotectin, a faecal marker of organic gastrointestinal abnormality. Lancet 2000, 356, 1783-1784.
17. Johnson, M.W., Maestranzi, S., Duffy, A.M. et al. Faecal calprotectin: a noninvasive diagnostic tool and marker of severity in pouchitis. Eur J Gastroenterol Hepatol 2008, 20, 174-179.
18. Kaiser, T., Langhorst, J., Wittkowski, H. Faecal S100A12 as a non-invasive marker distinguishing inflammatory bowel disease from irritable bowel syndrome. Gut 2007, 56, 1706-1713.
19. Langhorst, J., Elsenbruch, S., Koelzer, J. et al. Noninvasive markers in the assessment of intestinal inflammation in inflammatory bowel diseases: performance of fecal lactoferrin, calprotectin, and PMN-elastase, CRP, and clinical indices. Am J Gastroenterol 2008, 103, 162-169.
20. Langhorst, J., Elsenbruch, S., Mueller, T. et al. Comparison of 4 neutrophil-derived proteins in feces as indicators of disease activity in ulcerative colitis. Inflamm Bowel Dis 2005, 11, 1085-1091.
21. Lashner, B.A. How useful is fecal calprotectin for the diagnosis of IBD and colorectal cancer ? Nat Clin Pract Gastroenterol Hepatol 2008, 5, 16-17.
22. Leach, S.T., Yang, Z., Messina, I. et al. Serum and mucosal S100 proteins, calprotectin (S100A8/S100A9) and S100A12, are elevated at diagnosis in children with inflammatory bowel disease. Scand J Gastroenterol 2007, 42, 1321-1331.
23. Lundberg, J.O., Hellstrom, P., Fagerhol M.K. et al. Technology insight: calprotectin, lactoferrin and nitric oxide as novel markers of inflammatory bowel disease. Nat Clin Pract Gastroenterol Hepatol 2005, 2, 96-102.
24. Olafsdottir, E., Aksnes, L., Fluge, G. et al. Faecal calprotectin levels in infants with infantile colic, healthy infants, children with inflammatory bowel disease, children with recurrent abdominal pain and healthy children. Acta Paediatr 2002, 91, 45-50.
25. Pardi, D.S., Sandborn, W.J. Predicting relapse in patients with inflammatory bowel disease: what is the role of biomarkers? Gut 2005, 54, 321-322.
26. Parry, S., Forgacs, I. Intestinal infection and irritable bowel syndrome. Eur J Gastroenterol Hepatol 2005, 17, 5-9.
27. Roseth, A.G., Aadland, E., Jahnsen, J. et al. Assessment of disease activity in ulcerative colitis by faecal calprotectin, a novel granulocyte marker protein. Digestion 1997, 58, 176-180.
28. Schoepfer, A.M., Trummler, M., Seeholzer, P. et al. Accuracy of four fecal assays in the diagnosis of colitis. Dis Colon Rectum 2007, 50, 1697-1706.
29. Schoepfer, A.M., Trummler, M., Seeholzer, P. et al. Discriminating IBD from IBS: comparison of the test performance of fecal markers, blood leukocytes, CRP, and IBD antibodies. Inflamm Bowel Dis 2008, 14, 32-39.
30. Summerton, C.B., Longlands, M.G., Wiener, K. Faecal calprotectin: a marker of inflammation throughout the intestinal tract. Eur J Gastroenterol Hepatol 2002, 14, 841-845.
31. Tibble, J., Teahon, K., Thjodleifsson, B. et al. A simple method for assessing intestinal inflammation in Crohn’s disease. Gut 2000, 47, 506-513.
32. Vermeire, S., Van Assche, G., Rutgeerts, P. Laboratory markers in IBD: useful, magic, or unnecessary toys? Gut 2006, 55, 426-431.
33. Von Roon, A.C., Karamountzos, L., Purkayastha, S., Reese, G.E., Darzi, AW. et al. Diagnostic precision of fecal calprotectin for inflammatory bowel disease and colorectal malignancy. Am J Gastroenterol 2007, 102(4), 803-813.
34. Xiang, J.Y., Ouyang, Q., Li, G.D. Clinical value of fecal calprotectin in determining disease activity of ulcerative colitis. World J Gastroenterol 2008, 14, 53-57.
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