A coalition of U.K. research institutions and diagnostic developers backed by the British government has secured regulatory clearance to move ahead with their hand-held antibody blood test for COVID-19.
Together, they plan to jointly manufacture and ship millions of the finger-prick blood testers over the coming months, as part of a government campaign to provide free, widespread antibody screening for the novel coronavirus. Tens of thousands of the devices have already been produced in anticipation of the European green light, with a full rollout slated for the end of August.
Formed in April, the U.K. Rapid Test Consortium includes researchers at the University of Oxford and Ulster University as well as the test makers Abingdon Health, Omega Diagnostics, BBI Solutions and CIGA Healthcare.
Their lateral-flow diagnostic, dubbed the AbC-19 Rapid Test, uses a small drop of blood drawn from a finger and a reactive strip akin to a pregnancy test, and is designed to display a result within 20 minutes. It is made to be administered by healthcare professionals, and to detect IgG antibodies for the virus’s spike protein used to enter human cells.
The test went from early designs to receiving a CE mark in just 14 weeks, according to Abingdon Health. The company hopes the test will serve not only the current pandemic, but also future flare-ups and outbreaks of COVID-19.
“This U.K. designed, developed and manufactured high-quality rapid diagnostic test is a breakthrough for UK life sciences and a triumph of British business,” said Abingdon CEO Chris Yates.
“It has been a companywide effort at Abingdon Health to achieve this milestone in such a short space of time,” Yates added. “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.”
Recently announced clinical results showed the test to be at least 98.6% accurate overall. Following evaluations by Abingdon and Ulster University, it showed very low rates of false negatives and false positives, with a sensitivity of 98.03% and a specificity of 99.56%.
The company plans to produce 500,000 per month starting in October and one million per month from January of next year. The larger consortium aims to manufacture 10 million tests within a six-month period.
Additional trials are being set up to assess the test’s performance in the home setting over the coming months, for eventual use by the general public, with Ulster University seeking about 2,000 volunteers.