Abingdon Health, an international developer and manufacturer of rapid tests, has launched the BioSURE COVID-19 IgG Antibody Self Test.
In July 2021, Abingdon announced that it had signed an exclusive manufacturing agreement with BioSure (UK) Limited (“BioSure”), a company specialising in the provision of rapid in-vitro diagnostic testing solutions, including self-testing.
This new test, for which BioSure is the legal manufacturer, has been CE marked specifically for self-testing. The test uses a fraction of a drop of finger-prick blood (2.5uL) with results in 20 minutes. This allows individuals to know and monitor their own antibody status pre-vaccination, post vaccination and following infection with the SARS-CoV-2 virus. It will be particularly useful as populations worldwide continue to be vaccinated to monitor the effectiveness of an individual’s immunity status. This will have utility alongside potential booster vaccinations. Abingdon will be the exclusive worldwide manufacturer for the product.
The product has successfully completed technical transfer to manufacture following a pilot production run and is now in full manufacture at Abingdon’s expanded manufacturing facilities at York and Doncaster under the company’s ISO13485:2016 quality management system. Technical transfer is where three or more independent production runs are manufactured, at increasing scale, and validated to illustrate the product is suitable for mass manufacture.
Chris Yates, CEO of Abingdon Health, said: “We are delighted that BioSure have launched their product and equally happy to be their manufacturing partner. For individuals to be able to monitor their own antibody status at home is a great step in the management of COVID-19. Our own AbC-19 assay will complement this product and we expect the AbC-19 to gain additional utility in semi-quantitative format as recently announced. BioSure also distributes our AbC-19 test which is CE marked for professional use.
“This initiative allows us to build on our long-term collaboration with the BioSure team for whom we manufacture their HIV self-test in the same format as this new test. We are committed to supporting the deployment of these much-needed lateral flow tests to the UK and international markets. This is the first of several products we have previously noted to be going through the technical transfer process with others for COVID antigen and non-COVID applications to follow and which we expect to contribute to contract manufacturing revenue growth.”
Brigette Bard, CEO of BioSure, added: “We are delighted to be continuing the expansion of our product range with Abingdon Health. With our world-first CE marked COVID-19 antibody self-test, we need a world class manufacturing partner for supply into multiple markets. I would personally like to thank all of the team for their incredible work.”
