At least 23 deaths may have been caused by an error at a private lab after thousands of positive Covid cases were reported as negative, public health experts have estimated.
The error, at the Immensa Health Clinic Ltd laboratory in Wolverhampton, led to around 39,000 PCR tests returning negative results between September 2 and October 12, 2021 when they should have been positive – mostly in the south-west of England.
Immensa Health Clinic was incorporated in May 2020 by Andrea Riposati, a former management consultant and owner of a DNA testing company, two months after the declaration of a Covid pandemic by the British authorities.
The government awarded Immensa a £119m contract in October 2020 to “urgently scale up the volume of PCR testing for Covid in line with test and trace requirements”.
The contract was not put out to tender under rules allowing for urgent responses to the pandemic.
The UK Health Security Agency (UKHSA) estimated that the surveillance resulted in around 55,000 additional infections, around 680 additional hospitalizations and 23 additional deaths.
UKHSA experts estimated that each person who received a false negative result infected around two other people on average, although some continued to take action to reduce the spread of infection.
NHS testing and follow-up to suspended testing operations provided by Immensa in October 2021 following reports of inaccurate results.
An investigation, carried out by the UKHSA, concluded that the error occurred because laboratory staff had incorrectly set the thresholds for reporting positive and negative results.
Richard Gleave, UKHSA Director and Lead Investigator, said: “During this investigation we have looked carefully at the arrangements in place to oversee the contracts of private laboratories providing surge testing during this period.
“We have concluded that staff errors within Immensa’s laboratory in Wolverhampton were the immediate cause of the incorrect reporting of Covid PCR test results in September and October 2021.
“We are of the opinion that there was no single action that the NHS test and trace could have taken differently to prevent this error from occurring in the private laboratory.
“However, our report sets out clear recommendations to both reduce the risk of incidents like this happening again and ensure concerns are addressed and investigated promptly.”
Jenny Harries, UKHSA’s Chief Executive, said: “UKHSA is committed to being a transparent and learning organization, which means investigating issues and determining 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 became aware of the incident.
“These continuous improvements will strengthen our ability to detect problems earlier where they arise. We are especially keen to further improve the way we work with local partners and directors of public health as rapid incidents like this occur.