A user study for the Accubio Strep A Self-Test
Research type
Research Study
Full title
Usability Evaluation of the Accubio Strep A Self-Test (product code: GCSTR-502a-H1)
IRAS ID
344767
Contact name
Tara Moore
Contact email
Sponsor organisation
Accubio
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Background: The Accubio Strep A Self-Test is a qualitative assay for the detection of Strep A antigen in throat swab specimens, providing results in 5 minutes. Although performance data for the kit has been completed the test is intended for self-testing at home by lay-users and therefore user testing is required.
Aim: To assess the usability of the Accubio Strep A Self-Test by untrained representative lay-users of the intended user population.
Methods: Children and adults (n45-60; <12 years (n15-20), 12-16 years (n15-20), >16 years (n15-20)) will be recruited using social media, email and community recruitment. Participants who enrol in the study will attend one of the GP clinics to undertake their testing. During this appointment they will be given the Accubio Strep A Self-Test and asked to use the kit following the instructions provided while a trained researcher conducts a usability evaluation where use errors will be observed and recorded. Both the participant and the trained researcher will read the test independently once complete. The participant will be asked to give feedback on the Accubio test and to read test result pictures.
Outcome: The Accubio Strep A Self-Test will be considered acceptable if ≥90% of all tasks consolidated across all user groups are completed successfully and >80% of users score a 3 or above for the questions in the usability questionnaire.REC name
London - West London & GTAC Research Ethics Committee
REC reference
24/PR/0670
Date of REC Opinion
25 Jun 2024
REC opinion
Further Information Favourable Opinion