Intest Res.  2018 Oct;16(4):546-553. 10.5217/ir.2018.00052.

Experience of patients with inflammatory bowel disease in using a home fecal calprotectin test as an objective reported outcome for self-monitoring

• Wei SC
• Tung CC
• Weng MT
• Wong JM

• KMID: 2434156
• DOI: http://doi.org/10.5217/ir.2018.00052

Abstract

BACKGROUND/AIMS
Fecal calprotectin (fC) level is a predictive marker of mucosal healing for patients with inflammatory bowel disease (IBD). Home fC tests are now available. We evaluated the performance of the smartphone-based IBDoc home testing system in patients with IBD and obtained their feedback as an objective patient-reported outcome.
METHODS
This prospective study enrolled consecutive patients with IBD in clinical remission. fC in the same stool sample was assessed by using both the laboratory test (Quantum Blue calprotectin test) and home test (IBDoc). The correlation between the 2 tests was analyzed using the Pearson method. In addition, the patients were asked to fill a questionnaire based on their experience.
RESULTS
Fifty-one patients with IBD (68 tests and 49 questionnaires) were included. The correlation between Quantum Blue test and IBDoc was good (r=0.776, P < 0.0001). After the test, 56% patients found IBDoc easy to perform, and 96% were satisfied with it. Thirty-nine patients (80%) had a strong (>70%) probability to use it for future monitoring if the price was acceptable. By using 250 μg/g as the cutoff, the agreement between home test and laboratory results was 80%, and by using 600 μg/g as the cutoff, the agreement increased to 92%.
CONCLUSIONS
The correlation between the laboratory and home tests was good. Most patients found the home test to be feasible and easy to use and preferred it over laboratory test and endoscopy for monitoring. Therefore, the home test could be used as an objective patient-reported outcome.

Keyword

Crohn disease; Colitis, ulcerative; Fecal calprotectin

MeSH Terms

Colitis, Ulcerative
Crohn Disease
Endoscopy
Humans
Inflammatory Bowel Diseases*
Leukocyte L1 Antigen Complex*
Methods
Prospective Studies
Leukocyte L1 Antigen Complex

Figure

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  Fig. 1. Correlation between the home and laboratory fecal calprotectin (fC) test results (68 tests from 51 patients).

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  Fig. 2. Correlation between the home and laboratory fecal calprotectin (fC) test results (51 tests from 51 patients).

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  Fig. 3. Agreement between the home test and laboratory test results by using 250 μg/g as the cutoff value.

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  Fig. 4. Agreement between the home test and laboratory test results by using 600 μg/g as the cutoff value.

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