A new rapid point-of-care test for COVID-19 is a step closer to being made available following its move into official evaluation and validation following months of development. Scientists at the University of South Wales (USW) and their partners have 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 University to validate the test device and kits, in collaboration with manufacturing partners, Public Health Wales and NHS Wales.
Since the start of the pandemic the team has been developing the COVID-19 test at the labs within the University’s Glyntaff Campus in Pontypridd, to be able to quickly detect whether people are actively infected with the underlying SARS-CoV-2 virus. The test is based on a molecular diagnostic technology and is able to determine whether people are infected within 20 to 30 minutes.
The test has been trialled with healthcare workers from the Cwm Taff Morgannwg University Health Board. USW scientists then used these results to refine the accuracy and performance of the underlying molecular diagnostic technology.
The molecular technology, which is based on loop-mediated isothermal amplification of DNA (or LAMP), lends itself to point-of-care testing because no complex sample processing or expensive diagnostic equipment is required.
The research to date shows that the test performs well compared to the official Public Health Wales testing regime.
The team have formed strong links with industry and the health service to develop the test kits and the reader device. Working with engineers at GX Group the University has produced an electronic reader device which will process the test results. Bridgend based BioMonde have been supporting on the production of the test-kit assay element. In addition, the researchers have designed and trialled a unique saliva/nasal swab printed on 3D printers within Cwm Taf Morgannwg University Health Board.
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 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 Emma Hayhurst, who is also a lead scientist on the project, said: “The beauty of this test is that it is quick and portable. It doesn’t need to be processed in a lab and so when businesses, organisations or industries need to, for example, quickly test their workforce, the results can be available in less than 30 minutes, rather than 24 hours or more. There are so many possibilities for how this test can be used, for example, in care homes, hospitals, airports, dental labs and GP practices — even cruise liners.
“Initially we turned around the concept, which was based on a test we had developing over the last few years to detect Urinary Tract Infections, to reality in just a couple of weeks. The next step is for us to evaluate the pre-production prototypes, which this latest funding will now enable us to do, before it can get regulatory approval.”
Dr Ali Roula, Associate Professor in Biomedical Engineering at USW has led the development of the electronic device that will process and read the results. He said: “A key feature of any point-of-care diagnosis is ensuring it is able to reliably detect true positive COVID-19 cases while minimising false positives. We are ensuring this by providing signal processing and algorithmic expertise to augment the biochemistry.”
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.”
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.”
This is the second grant that USW has received from the Welsh Government to enable development of the test. The first grant of £50,000 earlier this year went towards the initial validation and refinement of the underlying molecular diagnostic technology.
The University of South Wales is supporting the formation of the spin-out company named Llusern Scientific to commercialise the test and the underpinning platform technology which has been developed at the University.
As part of this second phase of Welsh Government funded research, the University and its partners would be interested to receive contact details from organisations who may be interested in the rapid test for COVID-19. This will be used to contact you specifically about your requirements for testing. Please fill out the form on our homepage to register your interest or email your contact details to info@llusern.co.uk.