Covid-19 testing operations at a private laboratory in central England have been suspended after tens of thousands of people were handed potentially faulty negative PCR test results.
An estimated 43,000 people were given incorrect negative test results between September 8th and October 12th , the UK Health Security Agency (UKHSA) said on Friday. It said those affected, who were mainly based in south-west England, would be contacted by NHS Test and Trace and asked to take another test.
The lab was run by Immensa Health Clinic, a company with a limited history in diagnostics which was incorporated in May 2020. Italy-based company Dante Labs, which shares a founder with Immensa, is the subject of an investigation by the UK's Competition and Markets Authority.
In September, the UK watchdog launched an investigation into Dante Labs, a private travel testing provider, after customers complained it was failing to deliver tests and refusing requests for refunds.
Concerns about Immensa's facility in the West Midlands were first raised following reports of people receiving negative Covid results from gold-standard PCR tests, despite testing positive with the less accurate rapid antigen tests. The decision to halt the facility's operations followed an investigation by the UKHSA.
Dr Will Welfare, UKHSA's public health incident director, said: "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."
Immensa has been granted more than £180 million (€214 million) in contracts by NHS Test and Trace over the course of the pandemic. The most recent contract for PCR testing, worth more than £50 million, was agreed in July.
Christina Pagel, a mathematician and member of the Independent Sage group of scientists, said the problems with the lab "highlighted the issue with opaque awarding of contracts to firms with little relevant experience".
“The consequences of this is that many of those 43,000 people will have gone about their lives thinking they were negative and potentially infected thousands of others,” she added.
England’s Covid testing programme has come under fire throughout the pandemic for relying too heavily on expensive private contractors and providing poor service.
In March, the House of Commons public accounts committee concluded that the service had failed to make a “measurable difference” to controlling the pandemic, despite an “unimaginable” yearly budget totalling about £23 billion.
Jonathan Ashworth, Labour's shadow health secretary, described the decision to halt testing as "the latest fiasco in the sorry £37 billion tale of a system we were promised would be 'world beating'".
“Serious questions have to be asked about how this private firm – who didn’t exist pre-May 2020 – was awarded a lucrative £120 million contract to run this lab,” he added.
Andrea Riposati, Immensa's founder and chief executive, said the company was collaborating with the UKHSA investigation, adding that Immensa's labs had "proudly analysed" more than 2.5 million test samples for NHS Test and Trace over the course of the pandemic.
“Quality is paramount for us,” said Mr Riposati. “We do not wish this matter or anything else to tarnish the amazing work done by the UK in this pandemic.” – Copyright The Financial Times Limited 2021