Abingdon Health receives CE mark for COVID-19 antibody rapid test

Abingdon Health receives CE mark for COVID-19 antibody rapid test

Abingdon Health has received the CE mark for its COVID-19 antibody test, called AbC-19TM Rapid Test. The test is now approved for professional use in the UK and EU. The test uses a small drop of blood...

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Abingdon Health has received the CE mark for its COVID-19 antibody test, called AbC-19TM Rapid Test. The test is now approved for professional use in the UK and EU.

The test 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 will now be mass produced with roll out expected from the end of August. The company says it will produce 500,000 COVID-19 antibody tests a month from October and one million a month from January 2021.

AbC-19 Rapid Test detects IgG antibodies to the SARS-CoV-2 virus with 99.4% accuracy according to the company. Testing was performed at the Ulster University and at the laboratories of Abingdon Health.

Chris Yates, Abingdon Health CEO, 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.”

Abingdon Health is a UK-based medical device manufacturer. To develop and mass produce the volumes needed for the UK population, Abingdon Health set up and led the UK-Rapid Test Consortium (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 tests will also undergo ease of use trials with the general public to allow the Medical and Healthcare products Regulatory Agency 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 the Ulster University, using around 2000 volunteers.


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