Swab tests used by NHS halted over fears kits may be unsafe
CORONAVIRUS tests used by the NHS may be unsafe and have been halted, the Government has announced.
Matt Hancock, the Health Secretary, said that swabs in test kits, made by Northern Irish diagnostics firm Randox, have been found to have no CE health and safety mark, and when checked, were not up to standard.
Tests have been paused until further notice and the Department of Health said replacement kits would be sent out “as soon as possible”.
“We’ve identified some test swabs that are not up to the usual high standard that we expect and we’ll be carrying out further testing of this batch,” Mr Hancock told the House of Commons.
“As a precautionary measure, and while we investigate further, we’re requesting the use of these Randox swab test kits are paused in all settings until further notice.”
The Department of Health and Social Care was last night unable to say what the exact issue with the swabs had been, or confirm the number of tests that were affected. At least one testing centre in Liverpool was forced to stop testing completely because of the issue, and care homes received emails from the NHS asking them to “store unused Randox kits in a safe place” and ensure they are not used.
It is the latest embarrassment for Randox, which in 2017 was at the centre of a forensics scandal that led to at least 40 motorists convicted of drugdriving offences being cleared.
About 10,500 test results were reviewed after alleged manipulation of data by employees at the company, in what The National Police Chiefs’ Council described as a “most serious breach” of forensic science standards.
Police suspended all contracts with Randox, which had previously been used by 42 of the UK’S 45 police forces.
It is also 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.
In the same month Mark Menzies, the Conservative MP for Fylde in Lancashire, told the Commons that Randox had failed to provide urgently required test kits to residents in a care home in his constituency.
“Six of the remaining residents are displaying symptoms, but they are being told that they will have to wait until mid-june for further tests, following errors made by Randox a few weeks ago,” Mr Menzies said.
Randox agreed a £133million deal to supply testing services to the Government, the second-largest contract awarded. Only Hologic won a bigger contract worth £151million.
The Government was criticised for not putting out any of the contracts to tender in the rush to secure test kits.
It later emerged that Owen Paterson, the Conservative MP and former Northern Ireland secretary, is paid £100,000 by Randox as a consultant.
Randox was founded by Dr Peter Fitzgerald, a biochemistry researcher at Queen’s University Belfast, who set up the business in a chicken shed in the Eighties. It has since grown into a global diagnostics player, with annual turnover of more than £100 million and offices in 20 countries. Dr Fitzgerald is the 475th richest person in Britain with a £255 million fortune, according to the Sunday Times rich list.
The Department of Health said that the NHS test-and-trace service had been notified that some tests kits produced by Randox may not meet required safety standards.
A spokesman for the company said: “As an immediate precautionary measure we have temporarily suspended distribution of home sample collection kits using one particular batch/supplier of swabs. This is a temporary measure and does not apply to our private business, which uses a different supplier of swabs. Test results from Randox kits are not affected.”
Jonathan Ashworth, the shadow health minister, said: “Test and trace costs £10 billion and is increasingly chaotic with private firm after private firm failing to deliver.”