Rapid COVID-19 test is approved for professional use

A COVID-19 rapid antibody test, developed by York-based medical device manufacturer Abingdon Health, has been approved for professional use in the UK and EU.

The test, which will be named the “AbC-19TM Rapid Test”, will be mass produced and rolled out from the end of August.

It can be administered by healthcare professionals, such as doctors, nurses, pharmacists and healthcare workers. 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 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 test can help build a swift and clear picture of how the virus has spread throughout mass populations.

And it can also help establish the effectiveness of any vaccine which provides protection by creating new antibodies.

It has now been CE marked for professional use and has been registered with the Medical and Healthcare products Regulatory Agency (MHRA). 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-Rapid Test Consortium (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 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 10 million tests within a six-month period.

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 15 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 Young, said: “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.”

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