Usability Evaluation of the Accubio Prostate Health Self-Test
Research type
Research Study
Full title
Usability Evaluation of the Accubio Prostate Health Self-Test (product code: GEPSA-402a-H1)
IRAS ID
339414
Contact name
Tara Moore
Contact email
Sponsor organisation
Accubio
Duration of Study in the UK
0 years, 11 months, 28 days
Research summary
Background: The Accubio Prostate Health Self-Test is a qualitative assay for the detection of Prostate Specific Antigen (PSA) in whole blood to aid in the diagnosis of prostate diseases. 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 Prostate Health Self-Test by untrained representative lay-users of the intended user population.
Methods: A total of 100 men (40+ years) will be recruited using social media and community recruitment, and from patient lists in GP surgeries. 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 Prostate Health Self-Test kit 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 researcher will also take an additional fingerprick blood sample, to run on the CE marked professional use equivalent product that is available on the market (Zhejiang Orient Gene Biotech Co., Ltd.). The participant will be asked to give feedback on the Accubio test and to read a randomly assigned test result pictures.
Outcome: The prostate Health Self-Test will be considered acceptable if the overall agreement between the lay-user result and the professional result should be ≥95%.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
24/EM/0054
Date of REC Opinion
16 Feb 2024
REC opinion
Favourable Opinion