The UK-Rapid Test Consortium (UK-RTC), a group of scientists and expert medical manufacturers led by Abingdon Health, has announced that its point-of-care and home Covid-19 antibody test meets regulatory guidelines.
The UK-RTC was set up in April 2020 to develop and manufacture millions of Covid-19 antibody tests to determine if someone’s immune system has responded to infection from the virus.
This milestone is significant because it 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 10 months to reach this point, but it has been delivered in 10 weeks by Abingdon Health’s R&D team, working with experts at 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 a high-quality 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.
How does the test work?
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.
This reportedly makes the test more robust than ones that only detect antibodies which bind to part of the molecule or to other viral proteins.
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 one to two weeks after an infection.
Abingdon Health CEO, Chris Yates commented: “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 is expected to also be made available for home use.
The AbC-19 test at ‘design freeze’ reportedly shows a 98.6% accuracy.
Independent trials will continue throughout the scale-up phase. This will lead to CE marking, indicating health and safety conformity for goods sold in the EU, of the product for use at the point of care by healthcare professionals.
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.
About the UK-RTC
The UK-Rapid Test Consortium was set up by Abingdon Health to bring together scientists and medical technology manufacturers to be able to deliver millions of test kits as quickly as possible.
By working together, some of the UK’s leading medical technology companies will deliver more volume more quickly to help fight Covid-19.
The UK-RTC comprises Abingdon Health, the University of Oxford, Omega Diagnostics, BBI Solutions and CIGA Healthcare.
*Header image courtesy of Miguel Á. Padriñán via Pixabay, copy image courtesy of Shutterstock