The Department of Health has announced it is buying 1m home antibody tests from a British consortium, even though experts say the only data published about them raises major questions about their accuracy.
The government is spending millions of pounds on the tests, made by the UK Rapid Test Consortium. The UK-RTC was formed to develop a British antibody test after the fiasco over health secretary Matt Hancock’s purchase of 3.5m home antibody tests from China.
Sir John Bell, the government’s life sciences adviser, evaluated the Chinese pinprick tests and announced in April that they were not good enough. He then supported the formation of the consortium, led by Abingdon Health, to find a British solution.
In late August, Prof Jon Deeks, from Birmingham University, who heads the Royal Statistical Society’s working group drawing up guidelines for evaluating all types of Covid tests, said the data about the UK antibody test on Abingdon Health’s website “cannot be trusted”.
Public Health England has now done a full independent evaluation, but that is said to be going through peer review and the results have not yet been made public.
Deeks said there were major questions over the decision to go ahead and buy the tests.
“We don’t know how well this test works, so why is the government buying it? The first study undertaken by members of the consortium is critically flawed, as was pointed out many weeks ago,” he told the Guardian.
“The PHE independent study is finished, but the results are being kept secret from us. Another independent evaluation by the REACT team (at Imperial College London) is not yet finished. For the government to say ‘we follow the science’ is baloney. There is no rush for these tests, so why spend millions of pounds buying them before the evidence is complete and available for scrutiny?
“We wasted millions on poor Chinese tests in March, we wasted millions buying tests from Roche, which the government wrongly told us were 100% accurate – and now the government is failing to show us any valid evidence at all that suggests that spending millions buying these tests is sensible.”
It is understood the tests do not have commercial authorisation from the Medicines and Healthcare products Regulatory Agency for home use, even though it has been applied for, so they will be used for research. They will be sent to participants in surveillance studies to find out the levels of antibodies in the population. Surveillance is currently carried out through tests which have to be sent back to a lab for processing and participants are not told the result.
If rolled out to the public, people will be able to read the results themselves. Two blue lines in a window of a device resembling a pregnancy test means they have antibodies to the coronavirus, which may lead some people to assume they are immune.
Abingdon Health has said the evaluation will be published “in due course”. The Guardian was unable to contact them on Tuesday.
The Department of Health said the tests “demonstrate how, supported by government investment, the UK diagnostics industry is leading on the global stage in our efforts to tackle Covid-19”.
The health minister James Bethell said: “Home testing is a powerful tool in understanding the disease and fighting its spread. So we are thrilled by the RTC product, both for Britain and export markets around the world.”
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