UK COVID-19 Rapid Antibody Test Receives CE Mark for Use by Healthcare Professionals
Aug 14 2020 Read 371 Times
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 means it is approved for professional use in the UK and EU.
This milestone means the rapid test, for detection of IgG antibodies to the SARS-CoV-2 virus (COVID-19) is now available for distribution for professional use. It will be mass produced and tests will be rolled out from the end of August. The test can be administered by healthcare professionals, such as doctors, nurses, pharmacists and healthcare workers.
Following production of tens of thousands of tests across multiple production scale batches the test has been shown to be 99.40% accurate. Testing was performed at the Ulster University and at the laboratories of Abingdon Health.
The test will be named the ‘AbC-19TM 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 AbC-19 TM Rapid Test has been CE marked for professional use and has been registered with the Medical and Healthcare products Regulatory Agency (MHRA) declaring conformity with the essential requirements of the IVD Directive.
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.
In total, the UK-RTC can manufacture 10 million tests within a six-month period. Abingdon Health has acquired all the materials needed for all the members of the consortium to manufacture the test for this initial 10 million tests and the consortium is now ready to produce this high quality test at scale.
The test will detect IgG antibodies to the SARS-CoV-2 virus, specifically those IgG antibodies which react to the spike protein of the virus.
The tests will go through further independent evaluation over the next weeks.
More information online
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