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

Level of innovation

Two specialists thought that the tests were innovative; 1 specifically mentioned home testing. One specialist stated that they considered IBDoc to be innovative, based on their own experiences. Conversely, 2 specialists felt that the technologies were only a minor variation on the current UK standard of care.

None of the specialists was aware of any alternative technologies available on the NHS that offer similar functionality for point‑of‑care or home use.

Potential patient impact

Two specialists believed that almost all people with inflammatory bowel disease (IBD) could benefit from these tests; 2 others believed that they could benefit around half the population with IBD. One commentator felt that they would benefit people with stable IBD, and another felt they would most benefit people having an acute symptomatic episode and after resection surgery for Crohn's disease. However, another specialist felt the benefits of the tests were too uncertain to provide an estimate.

Two specialists stated that people who cannot or prefer not to attend clinic appointments would benefit from home‑use FC tests. One specialist commented that the tests were more appropriate for use in adults because of their low specificity in children, which may lead to unnecessary invasive procedures such as colonoscopies. Two specialists commented that FC testing is unlikely to change gastroenterologists' decision to request a colonoscopy.

One specialist mentioned this these FC tests would be beneficial if they allowed for more immediate assessment of symptoms as they arise. They noted that laboratory FC in their trust can take up to 4 weeks to provide results.

Three specialists mentioned the benefits of promoting self-management through home tests in people with IBD, citing reassurance of treatment efficacy, convenience and patients having control over their own condition. However, one specialist noted that the need to use a smartphone may limit the tests' usage. Another specialist commented that home testing would be the responsibility of the patient, and that there is a risk of incorrect usage. They also noted that the cost of using a smartphone to transmit the results, though negligible, must be paid by the patient themselves.

Two specialists suggested that unnecessary anxiety may be an issue with home testing when FC levels rise or if there are false positives. Using a traffic light rating scale may help ease anxiety in people using the tests.

Four specialists believed that the FC tests could improve clinical outcomes with fewer outpatient appointments and hospitalisations. One specialist noted that frequency of testing will affect the outcomes.

Potential system impact

Three specialists cited cost reductions from fewer colonoscopies and referrals to secondary care as benefits. One specialist believed that the FC tests would be cost neutral because of the higher associated acquisition costs, but another felt that the tests would increase costs in monitoring of children with IBD.

Two specialists noted that point‑of‑care and home‑use FC tests could move monitoring of IBD from secondary to primary care. They pointed out that this would mean changing follow-up pathways to include phone or online methods. Improved convenience for patients and testing for people in remote locations were cited as potential benefits. However, 1 specialist noted that heterogeneity in the results may lead to difficulties in interpreting and comparing the data.

Three specialists felt that training for both point‑of‑care and home‑use tests would be needed; 1 felt that if training were needed, a specific resource may need to be provided. One specialist noted that patient data protection and IT capabilities must be considered. Three specialists mentioned that patients and GPs may be reluctant to handle stool samples. Another commentator raised concerns over biohazard issues from handling stool samples in primary care or at home.

General comments

One specialist noted that it was unclear how these FC tests could be implemented and what benefits there would be. They stated that adherence to MHRA guidelines on point‑of‑care testing could be challenging for non-laboratory sites. Another pointed out that these tests may have lower accuracy and higher variability than laboratory-based tests. Two other specialists agreed that accuracy considerations must be considered before implementing point‑of‑care or home‑use FC tests.

Three specialists believed that these kinds of FC tests would be an addition to the current UK standard of care. One thought that they could replace laboratory FC testing.

Eurospital Calfast requires centrifugation of a stool sample before a test can be done. Three specialists confirmed this would potentially limit its application in primary care because it needs extra equipment, handling and staffing.

Three specialists mentioned the need for further research into the tests. This included investigations into their analytical performance, variability of outcomes in home testing, and resource utilisation studies from centres already using them.