Lab’s failures led to nearly 40,000 false negative COVID tests, says UKHSA
29 Nov 2022
A clinic set up just months after the initial outbreak of Covid-19 cases in the UK issued thousands of infected people with negative results before its testing commission was suspended.
Immensa was contracted to provide additional testing capacity from its Wolverhampton laboratory for NHS Test and Trace from 2 September last year
Weeks later on 12 October, 2021 the UK Health Security Agency (UKHSA) suspended all testing there after mounting reports of inaccurate results.
In a statement UKHSA the cause was incorrect setting of the threshold levels for reporting positive and negative results of PCR samples for coronavirus by staff in the Midlands laboratory.
This resulted in numerous PCR tests being reported by the lab as negative for COVID-19 when these would have been assessed as positive if the threshold had been fixed correctly.
“Based on background infection rates in different population groups at the time, UKHSA estimated that this error could have led to around 39,000 results being incorrectly reported as negative when they should have been positive,” stated the agency.
It added that this figure represented an estimated 10% of samples tested at the laboratory between 2 September and 12 October 2021. This amounted to 0.3% of all samples tested for NHS Test and Trace during this period said UKHSA.
UKHSA director and lead investigator Richard Gleave commented that: “It is our view that there was no single action that NHS Test and Trace could have taken differently to prevent this error arising in the private laboratory.”
Gleave added that throughout its investigation into the incident the agency had examined the arrangements for overseeing contracts of private labs providing surge testing.
“It is our view that there was no single action that NHS Test and Trace could have taken differently to prevent this error arising in the private laboratory,” he asserted.
However, he added that the UKHSA report had made recommendations to reduce the risk of such incidents recurring and to ensure matters were investigated quickly.
The BBC reported that Immensa chief Andrea Riposati, who had founded the company in May 2020, received a £119m contract from the government to carry out coronavirus PCR tests. Government rules introduced during the COVID pandemic meant the contract did not go to tender.
In the Guardian UKHSA was referenced as having estimated that an additional 55,000 infections, 680 additional hospital admissions and 23 deaths may have occurred from the debacle.
UKHSA Chief Executive Jenny Harries stated the agency was committed to investigating “where things have gone wrong and working out how things can be improved”.
“I fully accept the findings and recommendations made in this report, many of which were implemented as soon as UKHSA discovered the incident. These ongoing improvements will enhance our ability to spot problems sooner where they do arise,” she said.
