Fecal Calprotectin Test Performed at Home – a Prospective Study of Pediatric Patients with Inflammatory Bowel Disease

ABSTRACT Objectives: Measuring fecal calprotectin (FC) in a laboratory is time-consuming and that is why home tests have been developed. We studied the use of an FC home test in pediatric patients with inflammatory bowel disease (PIBD) in real-life settings. Methods: The patients were asked to perform the IBDoc® FC home test monthly for six months and to report their clinical disease activity at testing. However, clinical decision-making was guided by routine FC enzyme-linked immunosorbent assay (ELISA) for patients with raised IBDoc® values. Spare frozen samples were analyzed using ELISA and IBDoc® in the laboratory. The participants completed a questionnaire about FC testing at the start and end of the study. Results: Of the 52 patients, 35 (67%) aged 5–18 years completed the study and 197 home tests were performed. Of these, 15% failed, mainly because of technical reasons. Just under half of the patients (47%) considered home testing comparable or superior to routine testing. In contrast, the parents were unsatisfied (61%), mostly because the IBDoc® results were significantly different from ELISA and they found the phone application difficult to handle. But when the IBDoc® was performed by a laboratory professional it was comparable with ELISA, suggesting that practical issues hampered home testing. Despite their reservations, more than 80% of parents felt that home testing would improve disease management. Conclusions: PIBD patients and their families were interested in FC home monitoring and willing to adopt testing as a part of their disease management, but this approach requires thorough guidance. Address correspondence and reprint requests to Maija Piekkala, M.D., PhD, Children's Hospital, P.O.B 281, 00029 Helsinki, Finland (e-mail: maija.piekkala@helsinki.fi);Kaija-LeenaKolho,Ph.D.,M.D.,HospitalforChildrenandAdolescents,UniversityofHelsinki,Helsinki,FINLAND(e-mail:kaija-leena.kolho@helsinki.fi). Received 25 September, 2017 Accepted 29 November, 2017 Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal's Web site (www.jpgn.org). Conflicts of interest and Source of Funding: There are no conflicts of interest. The study was supported by Pediatric Research Foundation (Finland) and Helsinki University Hospital Research Fund (project TYH2015405) Abbvie donated the IBDoc® tests for the study, but had no role in the study design, the collection, analysis and interpretation of the data, writing the report or the decision to submit the paper. © 2017 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,

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