The UK-RTC has made significant progress in developing a COVID-19 lateral flow antibody test that can be used by people in their homes, since its inception 7 weeks ago. In addition, we have also made progress with the regulatory and logistics challenges needed to be overcome to support the Government in deploying the test directly to individuals across the UK.
With regards to the test progress, we are now consistently picking up positive samples across the range, including weak positives, whilst ensuring negative samples are not detected. We have conducted a small-scale study of 66 samples and results suggest the test is performing in line with design requirements. We expect to reach design freeze in June, which will allow us to move onto scale up, verification and validation activities, prior to the test being made available for manufacture.
In parallel with the above activities, we are working with Government and regulatory authorities to ensure proper approval of the test as quickly as possible.
The consortium is working with NHSX to develop a test specific app and digital service that will facilitate use and reading of the test device. This will have the ability to integrate with NHS systems and update records.
Finally, given the scale of the potential demand for the test within the UK, critical planning around supply chain logistics is also well under way, which will ensure a smooth introduction of the test directly to the public.
This is a very complex project that is being completed at extraordinary speed, compared to a normal test development programme, but thanks to the creative and hard work of everyone involved we remain on track to deliver a test to the UK that will make a significant difference to the approach needed to manage COVID-19 infections.
Chris Yates, CEO of Abingdon Health, commented:
“We are delighted with the progress made to date and are working hard to bring a quality home test at scale to the UK public. We have an excellent team of scientists and I would like to thank them for their dedication and hard work in getting the project to where it is today. We now move onto the next phase of this project and working with our partners in the consortium ensures we are able to scale the product to the desired volume quickly.“