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The Accuracy of a Home Performed Faecal Calprotectin Test in Paediatric Patients With Inflammatory Bowel Disease

Lerchova, Tereza; Hradsky, Ondrej; Copova, Ivana; Potuznikova, Kristyna; Gonsorcikova, Lucie; Bronsky, Jiri

Journal of Pediatric Gastroenterology and Nutrition: March 18, 2019 - Volume Publish Ahead of Print - Issue - p
doi: 10.1097/MPG.0000000000002331
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Objectives: Owing to the invasiveness of endoscopy, the use of biomarkers, especially faecal calprotectin (FC), has become standard for remission assessment. This study aimed to compare the accuracy for detection of endoscopic activity using recently developed FC home test using smartphone application (FC-IBDoc) against standard enzyme-linked immunosorbent assay (ELISA).

Methods: In all, 102 consecutive observations (89 participants) were included in prospective observational study. FC-IBDoc were performed parallely with FC-ELISA in paediatric patients with inflammatory bowel disease (IBD) indicated for endoscopy. Both tests were performed by trained staff. Mucosal healing was defined using Simple Endoscopic Score for Crohn's disease (CD) ≤ 2 in patients with CD (n = 44), Ulcerative colitis (UC) Endoscopic Index of Severity ≤ 4 in patients with UC (n = 27) and Rutgeert's score i0 and i1 without colon involvement in patients with CD after ileocaecal resection (n = 19).

Results: Out of 102 endoscopic findings 23 were assessed as mucosal healing. We found an association of the mucosal healing scores of the entire group both with FC-ELISA (p = 0.002) and FC-IBDoc (p = 0.001). The area under the receiver operating characteristic curve (AUC) for FC-ELISA was 0.883 (95% CI 0.807–0.960), with optimal cut-off at 136.5 μg/g. The AUC for FC-IBDoc was 0.792 (95% CI 0.688–0.895) with optimal cut-off at 48 μg/g. The FC-ELISA was more accurate than FC-IBDoc when tested by a Delong test (p = 0.023).

Conclusions: Standard FC-ELISA for FC evaluation is more reliable predictor of mucosal healing than the FC-IBDoc in paediatric IBD patients. The cut-off values for both tests were incongruous.

Department of Paediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic.

Address correspondence and reprint requests to Tereza Lerchova, MD, University Hospital Motol and Second Faculty of Medicine, V Uvalu 84, Prague 5, 150 06, Czech Republic (E-mail: terezadrskova@gmail.com).

Received 21 December, 2018

Accepted 24 February, 2019

Conflict of interest disclosure: Tereza Lerchova reports personal fees from Nutricia, outside the submitted work. Ondrej Hradsky reports personal fees from Abbvie, MSD, Nestlé, Nutricia, Ferring and Falk, outside the submitted work. Ivana Copova has nothing to disclose. Kristyna Potuznikova reports personal fees from Nestlé, Nutricia, and Mead Johnson, outside the submitted work. Lucie Gonsorcikova reports personal fees from Nutricia and Nestlé, outside the submitted work. Jiri Bronsky reports personal fees and non-financial support from AbbVie, Nutricia, Biocodex, personal fees from MSD, Nestlé, Ferring, Walmark, outside the submitted work.

Source of Funding: This work was supported by the Grant Agency of Charles University in Prague, [grant numbers 364617, 246216] and by Ministry of Health, Czech Republic – conceptual development of research organization, Motol University Hospital, Prague, Czech Republic [00064203].

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© 2019 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,