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Abingdon Health to mass produce Covid-19 antibody tests
The Covid-19 rapid antibody test, developed by Abingdon Health, the medical device manufacturer leading the UK-Rapid Test Consortium (UK-RTC), has received its CE mark.
This milestone means the rapid test, for detection of IgG antibodies to the SARS-CoV-2 virus (Covid-19), is now approved for professional use in the UK and EU. The test will be mass produced and rolled out from the end of August 2020. The firm plans to produce 500,000 Covid-19 antibody tests a month from October and one million a month from January 2021.
Following production of tens of thousands of tests across multiple production scale batches, the test has been shown to be 99.40% accurate.
The test will be named the AbC-19™ Rapid Test. It uses a small drop of blood from a finger-prick, and shows results in 20 minutes, without the need to send a sample to a lab.
The test can help build a swift and clear picture of how the virus has spread throughout mass populations. It can also help establish the effectiveness of any vaccine which provides protection by creating new antibodies. This information will be critical to managing current and future outbreaks of Covid-19.
To develop and mass produce the volumes needed for the UK population, Abingdon Health set up and led the UK-RTC in April this year. The consortium brings together the UK’s largest rapid test medical manufacturers, working together to provide capacity for delivery of more than a million tests per month.
The company has fast-tracked development and completed CE marking in just 14 weeks. This process could normally be expected to take 10 months or more.
Chris Yates, chief executive of Abingdon Health, said: “This UK designed, developed and manufactured high-quality rapid diagnostic test is a breakthrough for UK life sciences and a triumph of British business.
“It has been a company-wide effort at Abingdon Health to achieve this milestone in such a short space of time. Our research and development teams have been working two shifts a day, seven days a week, to develop the test. We have deployed nearly fifteen times the number of people that would be on a typical project to deliver this test as quickly as possible.”
Professor Lawrence Young, virologist at the University of Warwick Medical School, added: “A routine, reliable and easy-to-use test for Covid-19 antibodies will revolutionise our understanding of the coronavirus infection.
“For the first time it will allow us to get an accurate picture of who has been infected with the virus and help us to determine the level of protection induced by previous infection. It will also be a vital tool in determining the efficacy of any vaccine, particularly timely as some of the vaccines are now entering large scale phase III clinical trials.”
The antibody tests will go through further independent evaluation over the next few weeks. Alongside this, the tests will also undergo ease of use trials with the general public to allow the MHRA to provide the necessary approvals for it to be used by the public as a home test which is expected in the coming months. These trials will be performed in conjunction with Ulster University, using around 2,000 volunteers.