The UK-Rapid Test Consortium (UK-RTC), a group of UK scientists and medical manufacturers led by Abingdon Health, has reached “design freeze” for its Covid-19 antibody test.
The UK-RTC was set up in April 2020 to develop and manufacture Covid-19 antibody tests to determine if someone’s immune system has responded to infection from Covid-19.
This milestone means the technical design and manufacturing specifications for the antibody testing kit are complete and so preparation for mass production can begin.
It would usually take ten months to reach this point. It has been delivered in ten weeks by Abingdon Health’s R&D team, working with Oxford University.
The antibody test is being developed for the UK Department of Health and Social Care in response to the government’s need to procure an antibody test.
This followed a request by Professor Sir John Bell, regius professor of medicine at Oxford University, who asked Abingdon Health to work with experts at Oxford to begin the development process.
The next stages, before the kit is manufactured in large volumes, are scale-up of production processes, additional clinical testing and validation, and regulatory approval.
Abingdon Health CEO, Chris Yates said: “The results of our initial trials give us great confidence that our test will meet the regulatory thresholds defined by MHRA for a Covid-19 antibody testing kit. We then look forward to moving to mass production.
“This has been a tremendous company-wide effort at Abingdon Health to achieve this milestone in such a short space of time.
“The AbC-19 lateral flow test has been designed to be used at point of care, initially by healthcare professionals. In time it will also be made available for home use. The AbC-19 test at design freeze shows a 98.6% accuracy.”
Independent trials will continue throughout the scale-up phase which will lead to CE marking. Following this, additional field trials with the general public will allow MHRA to provide regulatory approval and CE marking for use by the public as a home test.
The AbC-19 lateral flow test uses detector molecules modelled on the “full spike proteins” of the Covid-19 virus making the assay detect antibodies which would bind to the native protein as seen on the virus.
The AbC-19 lateral flow test takes a drop of blood from the patient’s finger and detects whether the blood contains any Immunoglobulin G (IgG) antibodies to Covid-19. IgG antibodies typically begin to appear seven to fourteen days after an infection.