Successful independent evaluation from PHE for COVID-19 lateral flow antibody test
CRUMLIN-BASED BBI Solutions, a leading manufacturer of biological reagents and finished test platforms for the in-vitro diagnostics market, notes the press release issued by the UK Rapid Test Consortium (“UK-RTC”), of which BBI Solutions is a partner, on the UK Governments first order for one million COVID-19 lateral flow antibody tests (the “AbC-19™ Rapid test”).
This first order is part of the UK Governments plans to roll-out COVID-19 surveillance studies to help build a picture of how the virus has spread across the country.
The AbC-19™ Rapid test uses a small drop of blood from a finger-prick, and shows results in 20 minutes, without the need for a patient sample to be sent to a laboratory.
The test is currently CE-Marked for professional use, and can be administered by healthcare professionals, such as doctors, nurses, pharmacists and healthcare workers, at the point-of-care. The UK-RTC are seeking approval from the MHRA for self-test use.
The consortium will draw on BBI Solutions rapid test development and expertise, as well as its wider manufacturing capabilities, primarily at its headquarters at Crumlin, South Wales, and its site in Edinburgh.
BBI Solutions is also working closely with healthcare providers to optimise its smartphone diagnostic reader to be used in conjunction with the test. BBIs patented Novarum technology will guide users at home through performing a test before securely providing the results with their healthcare provider.
The UK-RTC is reproduced in full at the end of this statement.
Dr Mario Gualano, CEO, BBI Solutions, said: “I am delighted that the UK-RTC has now received its first contract from the UK Government for our COVID-19 lateral flow antibody test.
“We believe that the AbC-19™ Rapid test has the immediate opportunity to allow the UK to build a swift and clear picture of how the virus has spread throughout the population. It also has the potential to be deployed in conjunction with vaccine candidates to help assess initial immune responses.”
Press Release from the UK-RTC (issued on 6 October 2020):
UK-RTC AbC-19TM Rapid Test receives successful independent PHE evaluation
The UK Government has entered into a contract with Abingdon Health, on behalf of the UK-Rapid Test Consortium (“UK-RTC”), for the supply of the AbC-19TM Rapid Antibody tests. As part of the contract the UK Government has placed its first order for one million COVID-19 rapid antibody tests.
This follows an independent evaluation commissioned by the UK government of the AbC-19TM Rapid Antibody test, which will be published in full in due course by PHE, after peer review.
The “AbC-19TM Rapid Test”, uses a small drop of blood from a finger-prick, and shows results in 20 minutes, without the need to go to a specialised laboratory.
The test can be administered by healthcare professionals, such as doctors, nurses, pharmacists and healthcare workers, at the point-of-care. It has already received the “CE mark”, which indicates health and safety conformity for goods sold in the UK and EU.
The test will make it possible to build a swift and clear picture of how the virus has spread throughout the UK population.
It will also be able to 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.
Mass production is already under way. The antibody test will be rolled out under the governments COVID-19 surveillance studies to help build a picture of how the virus has spread across the country. Surveillance studies are vital to develop our understanding of how antibodies work.
The UK Government helped to set up the UK Rapid Test Consortium and invested in the development of the tests.
Health Minister Lord Bethell said: “This home antibody test developed by our outstanding British scientists and researchers at the UK Rapid Test Consortium will provide critical insight into how the infection has spread, growing our understanding of coronavirus so that we can better respond to it.”
The test detects IgG antibodies to “full trimeric spike proteins” of the SARS-CoV-2 virus. This means the test detects those antibodies which interfere with the viruss ability to enter the human cells.
An extensive validation study performed by Ulster University involving over 1000 participant blood samples is currently under peer review for publication.
About the UK-RTC
The UK-Rapid Test Consortium was set up by Abingdon Health to bring together scientists and medical technology manufacturers to be able to deliver millions of test kits as quickly as possible. By working together, some of the UKs leading medical technology companies will deliver more volume more quickly to help fight Covid-19.
The UK Government supported the setup of the UK Rapid Testing Consortium and invested in the development of the rapid antibody tests.
The UK-RTC comprises Abingdon Health, the University of Oxford, Omega Diagnostics, BBI Solutions and CIGA Healthcare.
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