Wolverhampton Covid testing lab not accredited despite assurances

A Covid-19 testing lab accused of producing thousands of incorrect results has not been accredited by the UK's regulatory body, despite the government saying it was.

Wolverhampton's Immensa Health Clinic is being investigated over a potential error with 43,000 negative results.

The UK Health Security Agency (UKHSA) had said it was "accredited with all appropriate standards".

But independent national accreditation body UKAS said that was not accurate.

Neither Immensa nor its sister company Dante Labs have been through a lengthy, three-stage process for private testing providers, UKAS told BBC News.

Testing work at the site has been suspended since the error was revealed.

The UKHSA said on Friday about 400,000 samples had been processed by the privately-run lab and it estimated 43,000 people may have been given incorrect negative test results.

Concerns were raised when people had positive lateral flow tests (LFTs) but negative follow-up PCR results between 8 September and 12 October.

About 4,000 cases were from Wales with others in south-east England and scattered across Britain.

There is no legal requirement for accreditation, but prof Alan McNally, from the University of Birmingham, said he wanted greater transparency.

When other labs were set up to process tests they had "incredible stringent checks and data was pored over every week" to ensure it met the standard expected, he said, adding "so if it didn't have those internal checks and it didn't have UKAS, I am not quite sure of what exactly did it have."

Dante Labs is listed on the government's website as having self-declared as meeting the minimum requirements for testing.

In a statement, the Department for Health and Social Care said due diligence was carried out for all government contracts and appointments.

"The Immensa laboratory in Wolverhampton passed an independent quality audit overseen by NHS Test and Trace and is in the early stages of the process for UKAS accreditation," the spokesperson said.

"We will confirm any next steps and reviews once the UK Health Security Agency has completed its investigation into this issue."

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