An estimated 43,000 people in England may have received an incorrect Covid test result due to “technical issues” at a private laboratory in Wolverhampton, where operations have since been suspended, the UK Health Security Agency has said.
This follows numerous reports of people receiving a negative PCR test result after previously returning a positive result through a Lateral Flow Device (LFD).
UKHSA is now investigating the lab, which is owned by Immensa Health Clinic, a private company that was first established in May 2020 and later handed a £120m contract by the government to provide testing services for the UK.
NHS Test and Trace estimate that around 400,000 samples have been processed through the lab. The 43,000 incorrect test results were handed out between 8 September and 12 October, UKHSA said.
Authorities are contacting the affected individuals, mostly in southwest England, who could still be infectious to advise them to take another test. Sites in southeast England which send their PCR tests to the Wolverhampton lab for processing have also been impacted.
“We have recently seen a rising number of positive LFD results subsequently testing negative on PCR,” said Dr Will Welfare, public health incident director at UKHSA.
“As a result of our investigation, we are working with NHS Test and Trace and the company to determine the laboratory technical issues which have led to inaccurate PCR results being issued to people. We have immediately suspended testing at this laboratory while we continue the investigation.”
UKHSA said there are no technical issues with the LFD or PCR test kits themselves. It added that the incident was specific to the one lab in Wolverhampton, with all samples now being redirected elsewhere for processing.
A number of testing sites have received incorrect test results in recent weeks as a result of the laboratory’s “technical issues”. On Friday, West Berkshire Council said that some of the tests at the Newbury Showground site “have had results sent out that may have incorrectly shown as negative for Covid-19”.
“After receiving reports from local residents in recent weeks that there were concerns about the accuracy of test results from the site, we passed these concerns onto the DHSC for further investigation,” the council said in a statement.
A DHSC source told The Independent that tests taken at the Newbury Showground site were processed by the Immensa Health Clinic lab in Wolverhampton, and that other national sites are likely to have been affected.
Those who received a negative result for a PCR test between 3 October and 12, as well as their close contacts, were “strongly” encouraged by West Berkshire Council to take another test.
UKHSA said no timeframe had been set for when its investigation into the laboratory will be concluded.
Dr Alexander Edwards, associate professor in biomedical technology at the University of Reading, said the “news is very disappointing” but insisted “we should remember that the sheer scale of Covid-19 testing is unprecedented.
“Let’s not throw the baby out with the bathwater. The majority of test results are correct, and it’s worth remembering that our testing system has been built up from almost nothing at the start of the pandemic.”
Immensa Health Clinic said it has analysed more than 2.5 million samples for NHS Test and Trace throughout the pandemic.
The £120m contract handed to the company did not go to tender under rules allowing urgent responses to the pandemic. It received a further £50m in July this year after striking a new testing deal with the government.
According to the Immensa website, the firm was new to Covid testing when it was founded last year. It said: "In 2020, we adapted and evolved into Covid-19 testing, taking advantage of our laboratory network, scientific expertise, and digital systems to deliver world-leading Covid-19 testing solutions."
Andrea Riposati, chief executive of Immensa Health Clinic, also runs Dante Lab, a travel testing provider that is under investigation by the Competition and Markets Authority (CMA) amid concerns that it is failing to deliver test results on time, or not at all, and refusing refunds when requested.
Mr Riposati said Immensa was “fully collaborating with UKHSA” as part of the investigation into the Wolverhampton lab. “Quality is paramount for us,” he said. “We do not wish this matter or anything else to tarnish the amazing work done by the UK in this pandemic.”