Immensa lab closed one month after ‘unusual’ Covid results first detected

Authorities were aware of discrepancies in Covid test results across England one month before the lab responsible was ordered to shut down its operations, legal papers show.

An estimated 43,000 incorrect false negative tests were processed for the NHS by the Immensa laboratory in Wolverhampton between 8 September and 12 October.

UK Health Security Agency became aware of an “unusual spike” in suspicious test results on 14 September, with large numbers of people testing positive on lateral flow devices but negative via PCR.

It took a month before the UKHSA determined that the “likely cause was a technical issue at the Immensa laboratory”, according to court papers filed by the government in response to a lawsuit.

The site was subsequently shut down on 12 October and remains closed as the UKHSA continues its investigation. An update is set to be provided in “due course”, the agency said.

“We cannot comment on any information that could form part of these investigations before they are complete,” it added.

It’s believed the UKHSA has credited blame to a failure of the site’s monitoring system.

The Independent also revealed in October how machines at the Wolverhampton lab were poorly maintained, concerns over quality control dismissed and untrained staff regularly “left to their own devices”.

Samples at the site were wrongly processed or cross-contaminated, leading to incorrect test results, while faulty air conditioning and fluctuating humidity levels within the lab also led to spoiled tests, whistleblowers said.

The government court papers show that it has yet to be precisely established just how many incorrect samples were sent out from by the lab to members of the public.

The 43,000 figure was “calculated by comparing average positivity across the [testing] network with the positivity output by Immensa,” the documents say.

Many of those affected were from the South West of England and South Wales. People who were infected with Covid were wrongly told they were negative and advised to stop isolating, increasing the risk of onward transmission.

The legal papers show that Immensa was only expected to report turnaround test times and samples that did not return a positive or negative result.

Immensa, which was only established in May 2020, has been awarded almost £170m of taxpayer’s money for Covid testing contracts throughout the pandemic.

Good Law Project, which is taking the government to court over the lab scandal, said: “It’s hard to imagine which is more remarkable: that it was citizen scientists on social media who first worked out that Immensa’s tests were failing – or that the government waited a whole month to act.”

Dr Will Welfare, incident director for Covid-19 at the UKHSA, said: “We suspended testing at the Immensa Wolverhampton laboratory following an ongoing investigation into positive LFD results subsequently testing negative on PCR. Those affected were contacted as soon as possible.”