The hunt for a “game-changing” antibody test may be over after a version backed by the UK Government passed its first major trials with flying colours.
Ministers are drawing up plans to distribute millions of free pregnancy-style tests after they were shown to be 98.6 per cent accurate in secret human trials held last month, The Telegraph can disclose.
Developed by Oxford University in partnership with leading UK diagnostics firms, the fingerprick test, designed for use at home, can tell within 20 minutes whether a person has ever been exposed to coronavirus.
Until now, the only antibody tests approved in the UK have involved blood samples sent to laboratories for analysis, which can take days.
“This rapid test appears to be truly amazing, and it shows we can do this ourselves,” said Sir John Bell, Oxford’s Regius Professor of Medicine, who leads the Government’s antibody testing programme.
Tens of thousands of prototypes have already been manufactured at factories across the UK in anticipation of expected regulatory approval in the coming weeks.
Ministers hope the AbC-19 lateral flow test will be available for use in a mass screening programme before the end of the year. The new tests have been developed by the UK Rapid Test Consortium (UK-RTC), a partnership between Oxford University and leading UK diagnostics firms including Abingdon Health, based in York.
The partnership was set up by the Government shortly after a consignment of Chinese-made fingerprick tests hailed by Boris Johnson as “game-changers” turned out to be largely useless.
Dr Chris Hand, the leader of the UK-RTC and chairman of Abingdon Health, revealed that the new UK-made test passed its first major clinical trial last month, involving nearly 300 people and conducted by scientists at Ulster University.
“It was found to be 98.6 per cent accurate, and that’s very good news,” Dr Hand told The Telegraph.
Results showed that the test produced a positive result in 98.8 per cent of cases where the patient was thought to have been infected with the virus. In patients who were not thought to have been infected, the test gave a negative test in 98.1 per cent of cases.
Overall that means a 98.6 per cent accuracy in a population where 10 per cent of the population are positive, or less than 2 per cent of either false positives or false negatives. The results were based on a sample of 292 patients.
Dr Hand added: “We’ve had two shifts of R&D personnel working day and night, seven days a week. This sort of development programme would normally take a year. We’ve done it in 10 weeks.
“We’re now scaling up with our partners to produce hundreds of thousands of doses every month.”
Whitehall sources warned, however, that scientists are still unsure whether the presence of antibodies means a person is immune to coronavirus and can return to normal life without fear of re-infection.
A Public Health England study, called Siren, is currently under way, in which thousands of health workers have had their blood analysed to try and discover whether antibodies confer immunity.
At Thursday’s Downing Street briefing, Dido Harding, the head of the NHS Test and Trace programme, said there were no plans “immediately” to roll out antibody testing until “the science gives us that answer we’re searching for”.
But Dr Hand revealed that the Department of Health is already in behind the scenes negotiations with the UK-RTC over the purchase of millions of tests before the end of the year.
“We’re working with the Department of Health on the commercial side of things, the procurement agreements and so on. One of the key things is to make sure that we provide value for money,” he said.
Under Government plans, the tests will be distributed to healthcare professionals first before being made available for millions of people to use at home, who would then send in their results to a central database.
“At the moment, this test is a tool to gather knowledge,” Dr Hand said. “The objective is to allow mass testing, which you can’t really do by sending samples to a lab. By being able to test millions of people, it will gather information so that we know how many people have antibodies, whether they protect against reinfection and how long they last.”
Under plans drawn up by officials, the tests would be free and ordered online rather than sold in supermarkets. Each kit will come in a box with a QR barcode linking to a video showing the user how to safely prick their own finger and administer the test.
Ministers also hope the tests will be useful in determining whether future vaccinations against coronavirus have triggered the desired response.
“If coronavirus is like flu and people need an annual vaccine, we will need mass antibody testing to measure people’s antibody response to that vaccine. That’s part of the plan,” Dr Hand said.
In April, the Medicines and Healthcare products Regulatory Agency (MHRA) banned fingerprick tests sold in Superdrug and Boots – with which users were asked to post blood samples for analysis – over concerns about accuracy.
Unlike many rivals, the UK-RTC version uses the “full-length spike protein” part of the virus to capture so-called IgG antibodies as blood passes through the home test. If the result is positive, two pink lines appear within 20 minutes.
“We’re using a particular capture mechanism for the antibodies which allows our test to be very sensitive,” Dr Hand said. “As far as we know, others were using other smaller fractions of the virus. Our scientific opinion and that of Oxford University is that the full-length spike protein is the way to go.”
Three batches of tens of thousands of prototypes have been manufactured for validation testing. In the next few weeks, data will be submitted to the MHRA watchdog for regulatory approval.
A Department of Health and Social Care spokesman said: “We have received an extraordinary response to our call to action to supply antibody tests, and we continue to work with industry to identify further tests that are safe and accurate to be used at home.
“While these tests will help us better understand how coronavirus is spreading across the country, we do not yet know whether antibodies indicate immunity from reinfection or transmission.”