A YORK diagnostics company has led a team to swiftly develop Covid-19 antibody tests which are now ready for mass production.

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 group was set up in April 2020 to develop and manufacture millions of antibody tests to determine if someone’s immune system had responded to infection from Covid-19.

This milestone means the technical design and manufacturing specifications for the antibody testing kit are complete, enabling mass production to begin.

It would usually take ten months to reach this point but has been delivered in ten weeks by Abingdon Health’s R&D team, working with experts at Oxford University.

The test is being developed for the UK Department of Health and Social Care.

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-19TM 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-19TM test at design freeze shows a 98.6 per cent accuracy.”

Independent trials will continue during 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 public will allow MHRA to provide regulatory approval and CE marking for use by the public as a home test.

The AbC-19TM 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 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-19TM 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 14 days after an infection.