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-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. To understand how the test works, Abingdon Health has released a new video: 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. Itcan 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.
Abingdon Health will begin to manufacture and ramp up production in August. The firm will produce 500,000 COVID-19 antibody tests a month from October and one million a month from January 2021. In total, the UK-RTC can manufacture 10m tests within a six-month period.
University of Warwick Medical School Virologist Professor Lawrence Youngsaid: “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.”