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. The Daily Telegraph reports that ministers are drawing up plans to distribute millions of free pregnancy-style tests after they were shown to be 98.6% accurate in secret human trials held last month.
Developed by Oxford University in partnership with leading UK diagnostics firms, the report says the finger-prick 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 UK government's antibody testing programme.
According to The Daily Telegraph, 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 report says 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 UK government shortly after a consignment of Chinese-made finger-prick tests hailed by Boris Johnson as "game-changers" turned out to be largely useless.
Dr Chris Hand, the leader of the UK-RTC and chair 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% accurate, and that's very good news,” Hand is quoted in the report as saying.
Results showed that the test produced a positive result in 98.8% 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% of cases.
Overall, that means a 98.6% accuracy in a population where 10% of the population are positive, or less than 2% of either false positives or false negatives. The results were based on a sample of 292 patients.
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."
The report says 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.
[link url="https://www.telegraph.co.uk/news/2020/07/17/exclusive-game-changing-coronavirus-antibody-test-passes-first/?WT.mc_id=e_DM1268103&WT.tsrc=email&etype=Edi_FAM_New_ES-A&utmsource=email&utm_medium=Edi_FAM_New_ES-A20200720&utm_campaign=DM1268103"]Full report in The Daily Telegraph[/link]