Government suspends use of NHS coronavirus test kits over ‘safety’ issue

The Department of Health said it would ‘be supporting all testing settings to receive replacement kits as soon as possible’

In a statement, the Department of Health and Social Care said: “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.”

Randox, which in March was awarded a £133m contract to deliver tests for use at home and in testing centres, said it had “temporarily suspended distribution of home sample collection kits using one particular batch [and] supplier of swabs”.

The exact nature of the issue is not known, but the DHSC said that "the risk to safety is low".

Updating the Commons on Thursday, Health Secretary Matt Hancock said: “We've identified some swabs that are not up to the usual high standard that we expect, and will be carrying out further testing of this batch as a proposed precautionary measure.“

But he added: “Clinical advice is that there is no evidence of any harm and the test results are not affected.”

Both the department and Randox have indicated that the problem does affect the accuracy of test results.

“This request only applies to unused Randox test kits, which are clearly marked with that name,” the DHSC said. 

“Used Randox test kits can still be collected for processing as normal. All other kits from NHS Test and Trace can continue to be used for testing.”

It is not yet clear what proportion of test kits are supplied by Randox, nor if testing facilities are likely to face a shortfall while their use is suspended. 

But the DHSC said that “we will be supporting all testing settings to receive replacement kits as soon as possible”.

PoliticsHome’s sister title Public Technology has contacted the DHSC to require further information. Randox supplied the same statement as is posted on their website.

The statement indicated that kits supplied for private testing purposes remain unaffected as this part of the firm's business "uses a different supplier of swabs".

Headquartered in Crumlin in Northern Ireland, Randox says it specialises in “innovative diagnostic solutions”. 

Based on its most recently filed accounts, which showed group turnover of £118.4m for the 2018 calendar year, the £133m coronavirus testing contract will see the company’s sales more than double in size overnight.

In April, the firm opted to extend its current financial reporting period to cover the 18 months to the end of June 2020, rather than the 2019 calendar year.

The DHSC's contract-award notice for the testing deal said: “Through this contract, Randox Laboratories Ltd will build on their track record and experience of providing clinical diagnostic solutions to provide DHSC with a turnkey service for laboratory testing out of its facility in Northern Ireland. 

“This service includes the supply of swab test kits delivered to subjects for use at home or NHS/PHE testing centres. Through the services under this contract, operations will be scaled significantly to support and contribute to the end of April national target of 100,000 tests per day. This scale is specific to Covid-19 testing and will increase capacity substantially.”

In the statement issued on Thursday, the health department said that Randox was appointed as a contracted supplier “alongside Lighthouse Laboratories” – a networking of facilities developed by the government, the Medicines Discovery Catapult, UK Biocentre and the University of Glasgow. The initiative is also supported by the NHS and Public Health England, as well as by pharmaceutical companies GSK and AstraZeneca and retailers Boots and Amazon.

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