Comparison of point-of-care PSA assay with lab methods, V0.1
Research type
Research Study
Full title
Analytical comparison of a point-of-care PSA assay system with laboratory-based reference methods in a community setting
IRAS ID
369530
Contact name
Anand Sharma
Contact email
Sponsor organisation
EDX Medical Limited
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
This study aims to assess a new rapid blood test that can be used in community settings to measure prostate-specific antigen (PSA). At present, PSA testing usually requires blood samples to be sent to a laboratory, which can take time and requires access to healthcare facilities. This research will compare a point-of-care test with standard laboratory testing using the same type of blood sample.
The study will take place at a single centre and will involve up to 2,000 participants aged between 40 and 79 who attend community-based PSA testing events run by charitable organisations. These events are held in familiar local settings such as sports clubs, social clubs and workplaces. Participants will already be having a blood sample taken as part of routine PSA testing. An additional small blood sample may be collected at the same time for the purposes of this study.
Each sample will be tested using both the point-of-care system and standard laboratory methods. The results will be compared to assess how closely the two methods agree. The study will also look at how easy the system is for healthcare professionals to use in community settings, and how well it fits into existing workflows.
In addition, the study will explore whether the system can measure more than one blood-based biomarker from a single sample. Participants will only attend one visit, and study information may be collected for up to one month afterwards. The findings will help inform the future development of accessible, community-based PSA testing approaches.
REC name
West of Scotland REC 3
REC reference
26/WS/0068
Date of REC Opinion
20 May 2026
REC opinion
Further Information Favourable Opinion