Article Text
Abstract
Introduction Faecal calprotectin (FCAL) is a useful test for monitoring of inflammatory bowel disease (IBD) activity. Providing a stool sample in person to the hospital laboratory is an anecdotally unpopular method with poor uptake. A new FCAL kit (IBDoc™, Bühlmann Labs AG, Switzerland) enables self-testing using a proprietary collection tube, camera smartphone and app. The aim of this study was to assess patient’s adherence to, and experience of, a testing regimen using IBDoc™, as well as benchmarking the assay to the standard laboratory test.
Methods After focussed training, participants were asked to test using IBDoc™ once a month for four months and provide a standard stool sample which was posted to the hospital laboratory overnight and refrigerated on receipt, to be tested with standard ELISA (Bühlmann). The following questionnaires were applied before and after testing: GAD-7 (anxiety), PHQ-9 (depression), IBD-control-8, Multi-dimensional Health Locus of control (MHLC) and Cognitive Behavioural Responses to Symptoms (CBSRQ). Patients were also asked to record their experiences and preferences for testing on a proprietary questionnaire. REC reference 15/WA/0168.
Results 54 consecutive patients (Crohn’s: 23, UC: 31, F = 28, mean age 36.0 ± 9.2 yrs) were enrolled. Participants completed a median of 3 tests (0–4) during the study with 19/54 (35%) completing all four set time points and 17/54 (32%) returning no samples, despite active reminders. There was no difference in any of the questionnaire scores between compliant and non-compliant patients.
There was moderate correlation of numerical FCAL results between the two testing methods (r = 0.77, 95%CI 0.68–0.84, p < 0.0001). Categorising results into disease activity categories (no inflammation, mild, moderate, severe) produced a similar result (weighted κ =0.57, p < 0.0001). 63% of respondents stated a preference for IBDoc™, but stated that (in a routine clinical scenario) they would require timely contact from the hospital team in the event of an abnormal result (24–72 hours). A further 22% preferred the IBDoc™ test, but stated that they would not contact until their next scheduled appointment.
Conclusion There was reasonable uptake and adherence to a demanding testing regimen (more frequent testing than might be required in routine clinical care) with 85% of respondents preferring the IBDoc™ test over other methods. The home testing kit results show only moderate correlation to laboratory ELISA. While this is a promising and clearly popular technology, therefore, further studies are warranted to correlate results to clinical outcomes.
Disclosure of Interest None Declared