Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Oct;16(4):546-553.
doi: 10.5217/ir.2018.00052. Epub 2018 Oct 10.

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

Shu-Chen Wei  1 , Chien-Chih Tung  2 , Meng-Tzu Weng  3   4 , Jau-Min Wong  1
Affiliations

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

Shu-Chen Wei et al. Intest Res. 2018 Oct.

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.

Keywords: Colitis, ulcerative; Crohn disease; Fecal calprotectin.

PubMed Disclaimer

Conflict of interest statement

CONFLICT OF INTEREST

No potential conflict of interest relevant to this article was reported.

Figures

Fig. 1.
Fig. 1.
Correlation between the home and laboratory fecal calprotectin (fC) test results (68 tests from 51 patients).
Fig. 2.
Fig. 2.
Correlation between the home and laboratory fecal calprotectin (fC) test results (51 tests from 51 patients).
Fig. 3.
Fig. 3.
Agreement between the home test and laboratory test results by using 250 μg/g as the cutoff value.
Fig. 4.
Fig. 4.
Agreement between the home test and laboratory test results by using 600 μg/g as the cutoff value.
See this image and copyright information in PMC

References

    1. Rutter M, Saunders B, Wilkinson K, et al. Severity of inflammation is a risk factor for colorectal neoplasia in ulcerative colitis. Gastroenterology. 2004;126:451–459. - PubMed
    1. Colombel JF, Panaccione R, Bossuyt P, et al. Effect of tight control management on Crohn’s disease (CALM): a multicentre, randomised, controlled phase 3 trial. Lancet. 2018;390:2779–2789. - PubMed
    1. Nielsen OH, Vainer B, Madsen SM, Seidelin JB, Heegaard NH. Established and emerging biological activity markers of inflammatory bowel disease. Am J Gastroenterol. 2000;95:359–367. - PubMed
    1. Vermeire S, Van Assche G, Rutgeerts P. Laboratory markers in IBD: useful, magic, or unnecessary toys? Gut. 2006;55:426–431. - PMC - PubMed
    1. D’Haens G, Ferrante M, Vermeire S, et al. Fecal calprotectin is a surrogate marker for endoscopic lesions in inflammatory bowel disease. Inflamm Bowel Dis. 2012;18:2218–2224. - PubMed

LinkOut - more resources