RE: UK COVID-19 rapid antibody tests are approved for professional use and commercial distribution as ma30 Jul 2020 08:45
UK COVID-19 rapid antibody tests approved for professional use
UK COVID-19 rapid antibody tests are approved for professional use and commercial distribution as mass production begins
Rapid antibody test receives CE mark for use by healthcare professionals
UK medical device manufacturers start mass production of millions of point-of-care 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 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.