Government seeks refund for millions of coronavirus antibody tests after trials show they are too unreliable for mass use

The Government will look for a refund for millions of coronavirus tests ordered from China after scientists found they were too unreliable to be used by the public.

Ministers will attempt to recoup taxpayers’ money spent on the fingerprick tests after an Oxford University trial found they returned inaccurate results.

The failure is a significant setback because it had been hoped the antibody tests would show who had already built up immunity, therefore offering a swifter route out of lockdown.

On March 25, Dr Sharon Peacock, from Public Health England (PHE), hailed fingerprick tests as a “game-changer” and suggested they would be available to the public within days.

But Professor Sir John Bell, from Oxford University, who advises the Government on life sciences, said on Monday that disappointing trials meant a mass antibody test was now at least a month away. He said no country in the world had yet rolled out a reliable antibody testing programme.

“Sadly, the tests we have looked at to date have not performed well,” he wrote in a blog post entitled ‘Trouble in testing land’. “We see many false negatives (tests where no antibody is detected despite the fact we know it is there) and we also see false positives.

“None of the tests we have validated would meet the criteria for a good test as agreed with the Medicines and Healthcare Products Regulatory Agency (MHRA). This is not a good result for test suppliers or for us.”

Last month, the Government ordered 3.5 million fingerprick tests, mainly from Chinese manufacturers, and later placed provisional orders for 17.5 million tests from nine firms including some based in the UK. None of the tests were found by Oxford to be reliable enough for mass use.

Sources said the Government would now work with the manufacturers to improve reliability, but Prof Bell suggested it could be time to go back to the drawing board and work to develop a test from scratch.

“There is a point in evaluating these first-generation tests where we need to stop and consider our options,” he said, adding that the search was on for a test sensitive and specific enough to mean it could be taken at home.

“That should be achievable, and the Government will be working with suppliers both new and old to try and deliver this result so we can scale up antibody testing for the British public,” he said. “This will take at least a month.”

Ministers reportedly spent millions of pounds of taxpayers’ money on the initial order of 3.5 million tests from two Chinese manufacturers, Wondfo and AllTest, which already have EU approval for use.

Last month, the Spanish government withdrew 58,000 Chinese-made coronavirus testing kits from use after it emerged that they had an accurate detection rate of just 30 per cent.

At Monday’s Downing Street press conference, Professor Chris Whitty said he was “not surprised” that the tests had been found to be unreliable, describing it as the “first pass”.

He added that the antibody tests would be more useful towards the end of the epidemic, when antibodies had been given time to develop and would be more easily detected. Ultimately, samples may need to be processed in NHS labs rather than at home, he added.

Professor John Newton, of PHE, who was appointed to oversee testing last week, said on Monday that the Chinese tests had failed to detect antibodies in patients who had suffered only mild symptoms.

“The test developed in China was validated against patients who were severely ill with a very large viral load, generating a large amount of antibodies, whereas we want to use the test in the context of a wider range of levels of infection, including people who are quite mildly infected,” he said.

It was claimed over the weekend that ministers also risk losing an opportunity to buy 400,000 tests a week from South Korean manufacturers because an offer had been ignored by officials.

Downing Street said it would seek refunds from companies that cannot improve the failed tests.

“We continue to work with the testing companies – we’re in a constant dialogue with them and we give feedback to them when their products fail to meet the required standards,” the Prime Minister’s official spokesman said. “If the tests don’t work then the orders that we placed will be cancelled and, wherever possible, we will recover the costs.”

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