title: Clinical implications of assay specific differences in f-calprotectin when monitoring inflammatory bowel disease activity over time.
abstract: OBJECTIVE
  With several faecal calprotectin (FC) assays on the market, it has been difficult to define a uniform threshold for discriminating between remission and active disease in patients with inflammatory bowel disease (IBD). We aimed to compare the results of different FC-assays in IBD patients, followed over time.
  
  
  METHODS
  IBD patients provided faecal samples and reported clinical activity every third month prospectively over a two year period. FC was measured with two ELISA - (Bühlmann and Immunodiagnostik) and one automated fluoroimmunoassay (Phadia).
  
  
  RESULTS
  In total, 13 patients provided 91 faecal samples. The median (IQR) concentration of FC was higher at active disease than at remission for all assays: Bühlmann 845 (1061-226) μg/g versus 62 (224-39) μg/g, Phadia 369 (975-122) μg/g versus 11 (52-11) μg/g, and Immundiagnostik 135 (302-69) μg/g versus 8 (56-4) μg/g. The Bühlmann assay produced the largest absolute difference but the corresponding relative difference seemed to be more pronounced when analysed by the Phadia - (ratio of means 8.5; 95% CI 3.3-21.9) or the Immundiagnostik assay (ratio of means 7.4; 95% CI 3.1-17.6) than by the Bühlmann assay (ratio of means 5.3; 95% CI 2.7-10.6). Consequently, the specificity for discriminating active disease from remission varied between assays (34-75%) when the cut-off 50 μg/g was used, whereas the differences in sensitivity were less pronounced.
  
  
  CONCLUSIONS
  Cross-comparisons revealed overall poor agreement between the assays as well as differences in the dynamics of FC. These findings suggest that standardisation of the method is needed to implement FC as a disease monitoring tool at large-scale.
authors.affiliation: a Dept of Gastroenterology, Faculty of Medicine and Health , Örebro University , Örebro , Sweden.
authors.forename: Karin
authors.initials: K
authors.lastname: Amcoff
authors.affiliation: b Dept of Medical Sciences , Uppsala University , Uppsala , Sweden.
authors.forename: Mats
authors.initials: M
authors.lastname: Stridsberg
authors.affiliation: c Dept of Medical Sciences, Gastroenterology Research Group , Uppsala University , Uppsala , Sweden.
authors.forename: Maria
authors.initials: M
authors.lastname: Lampinen
authors.affiliation: d Clinical Epidemiology and Biostatistics, School of Medical Sciences , Örebro University , Örebro , Sweden.
authors.forename: Anders
authors.initials: A
authors.lastname: Magnuson
authors.affiliation: c Dept of Medical Sciences, Gastroenterology Research Group , Uppsala University , Uppsala , Sweden.
authors.forename: Marie
authors.initials: M
authors.lastname: Carlson
authors.affiliation: a Dept of Gastroenterology, Faculty of Medicine and Health , Örebro University , Örebro , Sweden.
authors.forename: Jonas
authors.initials: J
authors.lastname: Halfvarson
mesh_terms: D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000032:analysis; D003113:Colonoscopy; D018450:Disease Progression; D004797:Enzyme-Linked Immunosorbent Assay; D005243:Feces / Q000737:chemistry; D005260:Female; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000145:classification / Q000378:metabolism*; D007413:Intestinal Mucosa / Q000378:metabolism; D039841:Leukocyte L1 Antigen Complex / Q000032:analysis*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index; D013548:Sweden
chemical_list: D015415:Biomarkers; D039841:Leukocyte L1 Antigen Complex
keywords: Biomarker; Crohn's disease; faecal calprotectin; inflammatory bowel disease; ulcerative colitis