Diagnostic Accuracy of a Novel COVID-19 Test - Version 1.0
Research type
Research Study
Full title
A prospective study to evaluate the real-world diagnostic accuracy and potential clinical impact of the Veros COVID-19 test in adults presenting to the Emergency Department with suspected COVID-19: ED-POC
IRAS ID
320705
Contact name
Tristan W Clark
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
COVID-19 continues to cause morbidity and mortality across the world. Even with vaccination and many more treatment options than were initially available, it will remain a burden on healthcare services and their patients for years to come. Diagnostic advances, allowing rapid and accurate results, have already improved patient outcomes and flow through hospitals.
The next generation of diagnostics is emerging in the form of analyser-free point-of-care tests which have the potential to be even faster and simpler to use.
One of these is the Veros COVID-19 test, by Sense Biodetection Limited. It is a novel point-of-care test that is analyser-free, requires no power source or dedicated user training and returns a qualitative result in 15 minutes. Initial data provided by Sense Biodetection Limited suggests that it has potential to be a good candidate for portable, rapid and analyser-free COVID-19 testing. This could lead to faster results on presentation to hospital, improving patient flow and reducing time spent in cohorted areas awaiting results.
We plan to undertake a real-world diagnostic accuracy study to assess the Veros COVID-19 test against a current reference standard (the GeneXpert Xpress SARS-CoV-2/Flu/RSV assay). We will evaluate diagnostic accuracy, time to test results and reliability and ease of use of the tests.
400 adults will be recruited, who have presented to the Emergency Department of Southampton General Hospital with symptoms of COVID-19 and who have capacity to consent to participating in the study. In parallel with GeneXpert COVID-19 testing (routine clinical care), anterior nasal swabs will be taken and tested on the Veros COVID-19 tests (with an additional nasopharyngeal swab taken to allow further tests to investigate discordant results).
The research will be funded by Sense Biodetection Limited, but they will have no involvement in the design of the study or analysis/publication of the results.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
22/NE/0225
Date of REC Opinion
5 Dec 2022
REC opinion
Favourable Opinion