Point-of-care and home faecal calprotectin tests for monitoring treatment response in inflammatory bowel disease

El-Matary et al. (2017)

Study size, design and location

77 children with IBD in a retrospective single-centre study, Canada.

Intervention and comparator(s)

Intervention: Quantum Blue (POC).

Comparator: standard practice, including ESR, CPR and clinical outcomes.

Key outcomes

86% of abnormal FC tests resulted in a treatment change that significantly improved clinical outcomes. 83% of children with normal FC measurements maintained remission on follow-up 3–6 months later. 88% of treatment decisions were based solely on FC testing.

Strengths and limitations

In the sample, the children were prescribed different medications (a total of 8 different medications were prescribed in the study, some children were prescribed multiple) and the performance of FC testing across different treatment regimens was not discussed.

Unlike most of the literature, in this study, FC testing did not correlate with CRP. Only 12% of the children had colonoscopies, so the prevalence of false negatives is unknown.

Ferreiro-Iglesias (2016)

Study size, design and location

53 adults with IBD in a prospective, cross-sectional, observational, single-centre study, Spain.

Intervention and comparator(s)

Intervention: Quantum Blue (POC).

Comparator: clinical symptom indexes (Harvey and Bradshaw index for CD, Partial Mayo index for UC).

Key outcomes

Monitoring of treatment with infliximab over 2 months found people with low FC levels when administering infliximab had no relapses during this time.

The sensitivity and specificity for predicting relapse was 91.7% and 82.9% respectively.

FC testing was the only independent predictor of IBD relapse (p<0.005).

Strengths and limitations

The follow-up period was just 2 months.

Clinical symptom questionnaires were used to define relapse, rather than colonoscopy.

Heida et al. (2017)

Study size, design and location

101 children and adults (aged 10 years or older) in a prospective single-centre comparative study, Netherlands.

Intervention and comparator(s)

Intervention: IBDoc (home use) and Quantum Blue (POC).

Comparator: laboratory ELISA (Buhlmann).

Key outcomes

Correlation was 0.94 for results obtained by IBDoc versus Quantum Blue and 0.85 for IBDoc versus ELISA. Discordant test result pairs (IBDoc versus ELISA or IBDoc versus Quantum Blue) that could potentially lead to different treatment outcomes occurred in 6 of 152 stool samples (4%).

In a self-reported usability questionnaire, 87% of respondents said the test was not difficult and 97% were interested in using the home test in the future.

Strengths and limitations

The proportion of children and adults, and the results for each of those groups, were not outlined in the study. IBDoc tests were done at home using patients' own smartphones.

There was a median delay of 2 days between IBDoc home testing and stool arriving at the hospital for Quantum Blue and laboratory ELISA testing; this delay could influence the agreement between the results

Only 62% of the patients completed the self-reported usability questionnaire.

Parr et al. (2016)

Study size, design and location

54 adults with IBD (23 people with CD and 31 people with UC), consecutively recruited in a prospective single-centre pilot study, UK.

Intervention and comparator(s)

Intervention: IBDoc (home use).

Comparator: laboratory ELISA (Buhlmann).

Key outcomes

Strong positive correlation of numerical FC results was reported between the 2 methods (r=0.77, p<0.0001). 63% of respondents preferred using IBDoc for routine testing, under the caveat that they could obtain contact from their designated healthcare professional (gastroenterologist or GP) within 1–3 days of receiving an abnormal IBDoc test result. A further 22% preferred the IBDoc test and stated that they did not think further contact before their next scheduled appointment was necessary.

Strengths and limitations

These results are from a poster abstract so there is limited information to assess study methodology. The IBDoc test was conducted once a month for 4 months at home without supervision, accurately replicating the intended environment of the test.

Ungar et al. (2017)

Study size, design and location

52 adults with CD in a prospective, single-centre study, Israel.

Intervention and comparator(s)

Intervention: IBDoc (home‑use) and Quantum Blue (POC).

Comparator: none.

Key outcomes

There was a strong correlation between results from both assays (r=0.924, p<0.0001). Level of education and age did not significantly influence the correlation between tests results (r>0.92, p<0.0001, for both comparisons).

However, in 27 out of 52 tests the difference in quantitative result of the paired tests was more than 25%.

Strengths and limitations

These results are from a poster abstract with limited details of methodology, the reference standard used or how educational status was considered. IBDoc was done under guidance by qualified personnel, which does not reflect the setting in which it is intended to be used.

Vinding et al. (2016)

Study size, design and location

221 adults with IBD (115 with UC and 106 with CD) in a prospective, single-centre randomised control trial, Denmark.

Intervention and comparator(s)

Intervention: CalproSmart (home use and POC).

Comparator: standard ELISA at 2 different laboratories (Buhlmann and Calpro).

Key outcomes

CalproSmart had high sensitivity (82%) and specificity (85%). A significant difference in the correlation between results was found based on educational status; 2 populations were defined according to whether or not they held a postgraduate degree. Both populations showed moderate positive correlation, but CalproSmart completed by people with postgraduate degrees aligned more significantly with the laboratory ELISA test. No other significant differences based upon population characteristics were identified.

Strengths and limitations

The tests were done in an outpatient clinic simulating a home environment. Patients were trained in accordance with manufacturer's recommendations. Patients used a phone provided by the researchers and not their own. This may have led to technical difficulties arising because of the smartphone technology rather than any difficulties in completing the test. No timer was provided during the experiment.

Abbreviations: AUC, area under curve; CD, Crohn's disease; erythrocyte sedimentation rate, ESR; C‑reactive protein, CRP; IBD, inflammatory bowel disease; POC, point of care; UC, ulcerative colitis.