Rapid antibody test receives CE mark for use by healthcare professionals

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.

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™ 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.

The company has fast-tracked development and completed CE marking in just 14 weeks. This process would normally take 10 months or more.

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. Abingdon Health has acquired all the materials needed for all the members of the consortium to manufacture the test for this initial 10m tests and the consortium is now ready to produce this high quality test at scale.

Abingdon Health CEO Chris Yates 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.”

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.”

Professor Mike Holmes, GP at HaxbyGroup and Vice-Chair at the RCGP said “the test is a real step forward; it’s safe, reliable and easy to use. I hope this will be welcomed by the public as vaccines become available and we all need to understand whether or not we are immune to COVID-19”

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. These are the type of antibodies the body produces to tackle and neutralise the virus.

The tests will go through further independent evaluation over the next weeks.

Alongside this, the tests will also undergo ease of use trials with the general public to allow the MHRA 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.

Learn more about AbC-19