Consortium10 Jun 2020 10:10
Seven weeks ago, the UK Government commissioned the UK-RTC to develop a COVID-19 lateral flow antibody test that can be used by people in their homes.
The UK-RTC says it has made ‘significant progress’ in both developing the antibody test, as well as progress with the regulatory and logistics challenges needed to be able to deploy the test directly with individuals across the UK.
The Consortium has reported that it is now consistently picking up positive samples across the range, including weak positives, while ensuring negative samples are not detected.
It has conducted a small-scale study of 66 samples, and results suggest the test is performing in line with design requirements.
Later this month, the UK-RTC expects to reach design freeze, a binding decision among the consortium partners, which will allow it to move onto scale up, verification and validation activities, prior to the test being made available for manufacture.
In parallel with the above activities, the consortium is working with the UK Government and regulatory authorities to ensure proper approval of the test as quickly as possible.
The consortium is working with NHSX, the technology, digital and data service of the NHS, 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.
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.
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