Coronavirus: New antibody test ‘with 99 per cent accuracy’ approved for use across Europe

A new antibody test to check whether someone has been infected with coronavirus, and said to be 99 per cent accurate, has been certified for use across Europe.

Global diagnostics specialists Abbott, which has a UK base in Maidenhead, has said it is expecting to have shipped millions of the laboratory based lab tests across Europe by the end of May.

The company’s diagnostic test has been given a CE mark showing it complies with EU safety rules and can now be used in labs across the UK to test for antibodies created when a person has been infected with Covid-19.

Dr Simon Clarke, associate professor in cellular microbiology at the University of Reading told The Independent the development of the test was “very significant”.

He said: “The test tells you whether you have ever been exposed to the virus and generated an immune response. What it can’t do is tell you whether you’re immune or not.

“Having antibodies in and of itself does not give you protective immunity, it might do, but we don’t know that.”

He explained that some coronavirus cause the common cold and leave sufferers with immunity that lasts only a short time. Because coronavirus is so new scientists still have no idea if immunity will last after infection.

Dr Clarke added the test was useful to authorities because it showed “how the virus has moved through the population” but added “for the general public it of no immediate utility.”

The test identifies the IgG protein the body produces when it has been infected by coronavirus and this can remain in the body for months and possibly years.

In tests Abbott claimed its product showed a sensitivity greater than 99 per cent, 14 days after symptoms were developed in 73 coronavirus-positive patients.

It was also more than 99 per cent specific in identifying that 1,070 negative samples did not contain Covid-19 antibodies.

The Abbott test, made in Europe, can be used in machines already in labs across the UK.

Testing is crucial to helping identify patients who have had the coronavirus infection and might be able to return to work because they have antibodies – and could be crucial for NHS workers and people in other key roles.

But the science behind immunity after infection is still unclear and it could be the case that people who have recovered from infection become susceptible again in the future.

Rolling out widespread testing both for infected and recovered coronavirus patients is likely to be a key part of government measures to end the UK lockdown imposed on 23 March.

Professor John Newton, who is leading the government’s efforts on testing, said antibody tests for the public could be available as soon as next month or early June.

He said: “We are optimistic that we will have a good antibody test when we need it, which of course is a little later in the progress of the pandemic,” he told the BBC. “Not many people would test positive for an antibody test if we had one now, so antibody tests come a little later.”

Mike Clayton, managing director of Abbott’s northern Europe diagnostics division said: “Abbott has been focused on bringing Covid-19 tests to market as quickly as possible to help address this pandemic.

“We are proud to be able to provide our antibody tests immediately as they will help understand who has had the virus, leading to greater confidence as we get back to living life. We are collaborating with the NHS, public health bodies and private laboratories across the UK to enable this test to be used here.”

Abbott is significantly scaling up its European manufacturing for antibody testing and has also said it will develop testing for detection of the antibody IgM in the near future to expand the range of possible antibody tests.

The health secretary told the daily Downing Street press conference on Tuesday that people over 65 and their families would now be eligible for testing, as well as people who leave their homes to work who have coronavirus symptoms.

Care home residents and staff will also be able to access tests, even if they do not have symptoms, as well as asymptomatic NHS patients and staff.

The demand for home testing kits has so far exceeded supplies with the government website for ordering tests forced to close within hours.

Key workers could no longer order any tests online by 9.10am on Monday – the fourth day in a row where tests became unavailable within hours of the booking system opening.

The kits ran out around two minutes after the service launched on Friday, and people were told there were none left on Saturday morning after around 15 minutes.