Credit: Katie Collins/EMPICS Entertainment

The NHS Test and Trace programme has suspended the use of coronavirus test kits provided by supplier Randox Laboratories after finding that they “may not meet our required safety standards”.

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, has said that it has “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, the DHSC said that "the risk to safety is low", and both the department and Randox indicated that it does affect the accuracy of test results.

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“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”.

PublicTechnology had contacted the DHSC requesting further information and was awaiting response at time of going to press. Randox supplied us with 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 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 today, 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.