Summary

Summary

  • The 5 technologies described in this briefing are point‑of‑care and home‑use faecal calprotectin tests for monitoring treatment response in people with inflammatory bowel disease (IBD).

  • The innovative aspect is that the test results can be acted on more quickly than waiting for standard laboratory tests. Most of the home‑use tests use smartphone apps. Information from the tests can be used to guide further treatment and inform the need for colonoscopy.

  • The intended place in therapy would be alongside clinical observations and patient-reported symptom severity in people having drug treatments for IBD, such as anti-TNF therapies.

  • The main points from the evidence summarised in this briefing are from 4 prospective studies, 1 retrospective study and 1 randomised controlled trial including a total of 558 patients. The evidence suggests that point‑of‑care and home‑use faecal calprotectin tests have comparable accuracy to laboratory ELISA tests, but with better patient satisfaction.

  • Key uncertainties around the evidence or technology are the lack of a standard NHS pathway for the use of faecal calprotectin. There is limited evidence on long-term clinical outcomes of treatments guided by faecal calprotectin tests or on the clinical impact of people self-testing in a home-setting. Only 1 of the 6 studies summarised included UK patients so there is also limited evidence of their use in an NHS care pathway, and there are limited data specific to children.

  • The cost of point‑of‑care and home‑use faecal calprotectin tests range from £23.25 to £85.85 per unit (exclusive of VAT). The resource impact would be greater than standard care because of the test costs, but this could be offset if their use reduces colonoscopies and clinical appointments. Costs may also be saved if the tests can more quickly identify ineffective treatments. Implementing the technologies may need changes to the NHS care pathway.

This briefing describes technologies which fulfil a similar purpose. During development, every effort was made to identify and include relevant technologies but others may not have been identified, or excluded when important information was unavailable.