Coronavirus tests used by the NHS may be unsafe and have been halted, the Government has announced.
Matt Hancock, the Health Secretary, is to make a statement in the House of Commons on Thursday afternoon about the problems with coronavirus kits, which could hamper widespread testing.
The Department of Health said the NHS Test and Trace service had been notified that some test kits produced by Randox Laboratories may not meet required safety standards.
"As a precautionary measure, and while we investigate further, NHS Test and Trace are requesting that all settings pause the use of Randox test kits with immediate effect and until further notice,” a Government statement said.
"The risk to safety is low and test results from Randox kits are not affected. We will be supporting all testing settings to receive replacement kits as soon as possible."
Randox was paid to carry out tests, both posted to individuals at home and administered at testing centres, as part of Mr Hancock's pledge to reach the target of 100,000 tests a day.
The company, based in County Antrim, Northern Ireland, supplies tests to more than 40 countries and won the second biggest contract for testing in the UK, worth £133 million. Only Hologic won a bigger contract, worth £151 million.
However the Government was criticised at the time after it emerged that the Tory MP Owen Paterson receives £100,000 a year from Randox to act as a consultant.
Randox's test results are available in less than hours as the tests and its analysers are capable of processing 54 patient samples simultaneously.
It is not the first time there have been problems with Randox during the pandemic. In May, testing was held up at the company's lab in Northern Ireland when a machine stopped working properly.
The Government was forced to send samples to a US laboratory for testing, but nearly 30,000 had to be voided because they were wrongly processed.
Samples have to be tested within 72 hours of the test being taken, which means any delay in their processing could leave people with symptoms unsure if they have the virus.
Randox has not yet responded to the announcement.
Separately, British company Diagnostics.ai has filed a claim in the High Court against the Government over the selection testing of companies by the Government.
The company claims that, based on testing of 100,000 a day, 1,000 tests a week are being falsely diagnosed as negative, meaning large numbers of people do not know they have coronavirus and so are not self-isolating.
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Professor Brian Glenville, the chairman of Diagnostics.ai, said: "We can confirm that we have submitted a claim to the High Court, seeking an urgent review of the choice of system used to support the analysis of Covid-19 tests.
"The Government had two systems to choose from: one with a near 100 per cent accuracy and one that was less accurate – for reasons best known to them, they chose the non-clinically validated, less accurate, system.
"This issue is one of urgent public health and safety, and we take no pleasure in issuing this claim."
The High Court has agreed the case should be expedited in the interests of public health and will hear the matter on September 23.