Evaluation of a lateral flow device for assessing H. pylori

• Research type

  Research Study

• Full title

  Performance and Usability Evaluation of the Accubio Stomach Ulcer Self-Test (product code: GCHP-602a-H1)

• IRAS ID

  332696

• Sponsor organisation

  Accubio

• Duration of Study in the UK

  0 years, 3 months, 13 days

• Research summary

  The lateral flow assay detects bacterial proteins for H. pylori antigens in faecal (stool) samples, allowing the detection of H. pylori, and hence potentially supporting the diagnosis of stomach ulcers or gastrointestinal disease. To evaluate this test, stool samples will be collected and tested and compared with a certified test. Usability and feedback will also be collected. Participants (n=100) will be recruited via email, social media or from existing recruitment databases. Each participant will assess their own sample by conducting a self-test while a professional user will assess the participant’s sample on both the new lateral flow test and on a certified approved CE marked lateral flow test (Newfoundland H. Pylori rapid test manufacture by All Test). Participants will be considered positive or negative for H. pylori based on certified testing. The specificity and sensitivity of the test will be calculated using the data collected. In addition, non-professional user feedback will be obtained from all participants. As part of the Ux element of the study ability to correctly interpret positive results outcome, participants will be asked to repeat a test with a spiked (negative or positive) buffer. The positive spike will be harmless dilution of H Pylori protein and live bacteria will not be used. Each participant will be asked to read the outcome of the test when a test (T) line of varying strength is visible on the lateral flow.

• REC name

  Wales REC 4

• REC reference

  23/WA/0251

• Date of REC Opinion

  9 Oct 2023

• REC opinion

  Further Information Favourable Opinion