Fecal Calprotectin Test Performed at Home: A Prospective Study of Pediatric Patients With Inflammatory Bowel Disease
Maija Piekkala1, Henrik Alfthan2, Laura Merras-Salmio1
1Children's Hospital, University of Helsinki and Helsinki University Hospital.
Insights
Home fecal calprotectin (FC) tests show promise for pediatric inflammatory bowel disease (PIBD) management. While patients were positive, parents reported issues with accuracy and usability, highlighting the need for guidance.
Area of Science:
- Gastroenterology
- Pediatrics
- Biotechnology
Background:
- Laboratory measurement of fecal calprotectin (FC) is time-consuming.
- Home-based FC testing offers a potential alternative for monitoring inflammatory bowel disease (IBD).
- Pediatric IBD (PIBD) management can benefit from accessible monitoring tools.
Purpose of the Study:
- To evaluate the real-world utility of an FC home test in PIBD patients.
- To assess patient and parent satisfaction with home FC testing.
- To compare home test results with laboratory-based enzyme-linked immunosorbent assay (ELISA).
Main Methods:
- Monthly home FC testing using the IBDoc system for 6 months in PIBD patients.
- Clinical decision-making guided by routine FC ELISA for elevated home test values.
- Laboratory analysis of spare samples using both ELISA and IBDoc; participant questionnaires.
Main Results:
- 35 of 52 eligible PIBD patients completed the study, performing 197 home tests.
- 15% of home tests failed due to technical issues; 47% of patients found home testing comparable or superior.
- 61% of parents were unsatisfied due to perceived result discrepancies and app difficulties, though 80% believed home testing could improve disease management.
Conclusions:
- PIBD patients and families are interested in FC home monitoring.
- Willingness to adopt home testing exists but requires comprehensive user guidance.
- Practical challenges in home testing need to be addressed for successful implementation.
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 6 months and to report their clinical disease activity at testing. Clinical decision-making, however, 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%) ages 5 to 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 whenever 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.
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