P134 Home based faecal calprotectin testing: a Canadian user performance evaluation study of IBDoc®

Fecal Calprotectin (FC) is a stool biomarker that has previously been shown to be sensitive and specific for mucosal inflammation in patients with inflammatory bowel disease (IBD). The test is limited by the requirement for patients to collect and return stool samples. A previous study showed a sample return rate of 78%. The objective was to determine the usability of IBDoc®, a home based FC test, designed to allow patients to independently determine their FC levels without the need to return a stool sample to a laboratory or doctor’s office and thereby improve test adherence. Patients were prospectively enrolled from three sites across Canada between May to August, 2017. Patients were given a demonstration at the clinic on how to use the IBDoc® prior to performing the test. Patients brought their stool sample to the site to perform one IBDoc® test. Three extracts from the same stool sample were prepared by the study coordinators and sent to a central laboratory site for a comparative reference ELISA measurements. Additionally, the extracts prepared by the patients were also measured by ELISA. Patient values were compared with an average value from three ELISA measurements as well as the IBDoc® categorical values of normal (<100 µg/g), moderate (100–299 µg/g), or high (>300 µg/g). A self-reported patient questionnaire using 5-point Likert scales (1 = “strongly disagree”, 5 = “strongly agree”) was used to determine ease-of-use of the IBDoc® device. 61 participants were enrolled in the study of which 34% (21) were male with an average age of 34.8 ± 9.0 years. 51 patients had both IBDoc® and ELISA measurements available for comparison, resulting in agreement across values 88% of the time and which was highly correlated (r = 0.88). Using the qualitative comparison, there were no false positives or negatives. The patients extracts and reference ELISA measurements demonstrated an 89% agreement between values, which was also highly correlated (r =0.97) and with no false positives or negatives in the qualitative comparison. Ninety-seven per cent (59/61) positively responded that they had understood the instruction in the App. 79% (48/61) of patients agreed that the IBDoc® was easy to use with 85% (52/61) of patients strongly agreeing that they were willing use the home kit in the future and an average rating of 4.5 ± 0.89. The FC measurements produced by patients using the IBDoc® were strongly correlated with the standard FC ELISA measurements. The majority of patients found the IBDoc® home kit easy to use and a product that they would likely to use in the future. Further studies are needed to determine whether patients adopt the device for use beyond the clinical trial setting and to assess its impact on patient care for IBD.

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