COVID-19 RAPID ANTIBODY TESTS APPROVED FOR MASS PRODUCTION6 Aug 2020 07:40
Published: 04/08/2020
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.
To understand how the test works, Abingdon Health has released a new video here: www.youtube.com/watch?v=WqT2z8jCEHs.
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.
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. CE marking indicates health and safety conformity for goods sold in the EU.
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........
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