‘Significant progress’ on test for antibodies
THE UK-Rapid Test Consortium is making “significant progress” to develop a Covid-19 lateral flow antibody test, according to the Crumlinbased BBI Solutions.
Seven weeks ago the UK Government commissioned the UK-RTC to develop an antibody test for Covid19 that can be used by people in their homes.
The UK-RTC said as well as the “significant progress” it has made progress with the regulatory and logistical 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 on to scale-up, verification and validation activities, prior to the test being made available for manufacture.
In parallel with the 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, they say critical planning regarding supply chain logistics is also well under way, which will ensure a smooth introduction of the test directly to the public.
BBI Solutions is playing a role in the development of the app and providing reagents for the test.
BBI Group chief executive Dr Mario Gualano said: “This is a very complex project that is being completed at extraordinary speed, compared to a normal test development programme.
“But 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.
“We are proud to be an integral part of this project, and are delighted with the progress to date.”