Cwm Taf Morgannwg UHB has been working with scientists from the University of South Wales on a rapid point-of-care COVID-19 test.
The University team has been awarded funding from the Welsh Government’s innovation department to validate the test.
The grant of £115,341 from Welsh Government’s Covid Response, Research, Development and Innovation Solutions fund will enable the validation of the test device and kits, in collaboration with manufacturing partners, Public Health Wales and NHS Wales.
The test has been trialled with healthcare workers from CTM. USW scientists then used these results to refine the accuracy and performance of the underlying molecular diagnostic technology.
The research to date shows that the test performs well compared to the official Public Health Wales testing regime.
In addition, the researchers have designed and trialled a unique saliva/nasal swab printed on 3D printers within the UHB.
The Welsh Government grant will enable the pre-production prototypes of both the electronic device and the molecular assay element of the test to be evaluated and validated for regulatory approval. This could lead to the test being available for use in early 2021.
Dr Tom Powell Innovation lead for Cwm Taf Morgannwg UHB said: “This has been a great opportunity to work closely with the USW team to help develop this new approach to testing. As we all know rapid and accurate testing is really important to help tackle and prevent the spread of Covid-19. We’ve also been able to adapt our 3D printing capacity to produce bespoke saliva/nasal swabs that have been used in the trials which has been really exciting.”
Dr Jeroen Nieuwland, one of the lead scientists on the project, said: “It has been an incredibly busy few months as we honed the underlying molecular technology of the test to be confident that we can accurately detect Covid-19. We also now have a pre-production prototype of the electronic reader device that will process the test results in 20 to 30 minutes and a unique saliva/nasal probe, which works well for non-invasive swabbing and means that patients can take their own virus swabs. This then goes straight into the assay and then into the machine. This obviously cuts the risk of any further spread of Covid-19 and makes the test truly point-of-care.
“Our main aim has always been to produce a test that is quick, accurate and most importantly cost effective, so that it could be made widely available, particularly if there is a second wave or increasing incidents of localised lockdowns. We still have a bit of a way to go for regulatory approval but we are confident that we are producing a high-quality, low-cost test.”
Dr Catherine Moore, Consultant Clinical Scientist from Public Health Wales’s Virology Centre, said: “It’s exciting to work with USW on what has the potential to be a true mobile point of care system. Having seen the prototype model, it’s clear that a great deal of thought has gone into the design to allow it to be used outside of the laboratory/hospital setting. By working with us collaboratively in the Public Health Wales Specialist Virology Centre, we plan to generate sensitivity and specificity data for the sample to answer process to allow it to be used safely in the wider community to support the COVID-19 response.”