An NIHR-supported trial is investigating whether a 60-second test could cut the time to diagnose winter respiratory viral infections.
If proven to be accurate, the point-of-care test could provide the NHS with a highly scalable, low-cost diagnostic tool. This could help clinicians make faster decisions and improve patient care during future winter periods, when hospitals face intense pressure from respiratory infections.
The trial is being delivered through the NIHR Southampton Biomedical Research Centre (BRC) at University Hospital Southampton (UHS).
Comparing new technology to current methods
Current hospital polymerase chain reaction (PCR) test processes can take over 2 hours to deliver a result, require laboratory processing and are expensive to perform. The new platform can be used by staff without specialist training. It could cost between £2 and £3 per test, which is comparable to lateral flow devices and would be at least 10 times cheaper than current rapid PCR testing.
The technology, developed by the UK medical device company Ediphor, uses novel biosensor technology to identify respiratory viruses in just 60 seconds. The entire test process, including sample collection, takes around 4 minutes.
Professor Tristan Clark, study lead at the NIHR Southampton BRC, said: “This novel and exciting technology has the potential to be a real game-changer. Rapid, accurate diagnosis is crucial during winter surges, but current testing methods are too slow and often very expensive.
“A cheap, accurate test which delivers results in just a few minutes could transform how we manage respiratory infections in hospitals as well as in other settings.”
Respiratory viruses such as flu, COVID-19 and respiratory syncytial virus (RSV) are a major driver of winter pressure in the NHS, accounting for a high proportion of emergency department attendances during peak winter periods. This increase in A&E attendance and hospitalisation often leads to significant operational problems including lack of bed capacity and cancellation of elective surgery.
The trial, which is already underway at UHS, will evaluate the accuracy and performance of the test by comparing it with existing diagnostic methods. The data collected will be analysed in order to help build the evidence needed for regulatory approval and future NHS adoption.
Professor Clark, an Honorary Consultant in Infectious Diseases at UHS and Professor at the University of Southampton, added: “While this study won’t change how we manage patients this winter, it’s a vital step in generating the evidence required to support new diagnostic technologies that could make a significant difference in years to come.
“In addition, this technology is uniquely flexible in that it can be adapted to detect many different types of biomolecular targets, and not just respiratory viruses”.
Professor Clark was recently awarded a highly prestigious NIHR Research Professorship. This new trial builds on his long-standing expertise in infectious disease diagnostics and translational research, including earlier work on rapid flu testing published in The Lancet Respiratory Medicine.
The findings from the study will inform future clinical trials and decision-making around the use of rapid diagnostics during periods of peak demand.