An estimated 20 people died because of the weeks of false negative Covid test results from the Immensa lab testing scandal, the UK’s health authority has admitted. A report has finally been published about the failure of the testing facilities in Wolverhampton for six weeks in September and October 2021, which mainly affected people in the West Country.
The UK Health Security Agency's report has revealed cases in the South West and in South Wales were noticeably higher for weeks during and after the testing failures began, and thousands of people ended up hospitalised with Covid who would probably not have even caught the virus if the tests had been done properly.
Data analysis in the report states: "We estimate that there were around 39,000 additional incorrect negatives from the laboratory than would have been expected had the samples been processed elsewhere during this period. This is our preferred estimate, which accounts for differences in age, test site, region and date.
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"We estimate there were about 680 additional hospitalisations in the affected areas that may not otherwise have occurred, based on a comparison of the observed data in affected and comparator areas...Similarly, we estimate that there may have been just over 20 additional deaths in these most affected areas."
The report outlines what happened at the Immensa lab in Wolverhampton. It was the location where hundreds of thousands of covid tests were sent from testing stations across Gloucestershire, Wiltshire, Bristol, Somerset and South Wales, but from September 2, 2021, something went wrong.
The UK Health Security Authority report said the problem was down to errors in the setting of thresholds for covid testing, and there had been a long history of problems with the lab. The UKHSA had received concerns about the standards of test results coming out of the Wolverhampton lab, which had been set up in 2020 as a response to the Covid pandemic. One contract for testing had already ended in March 2021, weeks after the Welsh Government expressed concerns about the numbers of false positive test results among care home staff, and a couple of months after The Sun published an investigation into working practices within the lab.
Tests weren’t processed at the lab again during the spring and summer of 2021, but then the UKHSA issued new ‘surge-testing’ contracts, and the Immensa lab in Wolverhampton was awarded one, which began on September 2, 2021. Almost immediately, people began reporting false negative test results.
Within a few weeks, people in Bristol, Gloucestershire and Wiltshire began sharing stories on social media of how they had carried out lateral flow tests at home which were positive, they had all the classic Covid symptoms, but they went to an NHS testing facility and the test result came back negative. It took six weeks for the UKHSA to shut down the Immensa lab in Wolverhampton, but for tens of thousands of people who had been wrongly told they didn’t have Covid - and the people they then passed on the virus to - the damage had already been done.
As part of the UKHSA report into the scandal, researchers, scientists and mathematicians investigated the knock-on effects of the scandal. They compared Covid infection rates at the time in the affected areas of the West Country and South Wales with five other areas around the country where the testing system was known to be robust.
While it will never be known on an individual basis exactly how many tests were recorded as negative that were actually positive, the calculations made have revealed that the number of false negative test results issued from the Immensa lab when its second contract began on September 2, 2021 to when it was ordered to stop testing on October 12, 2021 was around 39,000. This is a slight reduction in the total number of false negatives initially revealed by the UKHSA at the time, who back then put it at around 42,000.
But many of those 39,000 people, told they did not have Covid, went on to unwittingly infect other people - who also then went onto infect other people. The virus in the West Country region spiked much more than in other areas of the country during September and well into October. The researchers have attempted to work out how much of that increase in case numbers was down to the virus naturally being transmitted, and how much could be linked to the failures at the testing centre.
For the first time, the researchers have calculated how many people are estimated to have been affected. “We estimate that the incident led to about 24,100 additional cases across the most affected areas between September 2 and October 31. We estimate that this incident led to an additional 55,000 infections. That suggests each wrongly reported test result led to just over two additional infections on average,” the report said, adding that while many people would not have passed the virus on to anyone, there would have been a ‘substantial tail with multiple onward infections’ - in other words, some people who were told they didn’t have Covid, went on to be ‘super-spreaders’.
A percentage of those people who caught Covid who otherwise would not have done, became seriously ill. The researchers said they came to their figures using observed data - actual test numbers and hospitalisation numbers - but it is impossible to accurately say whether someone who was hospitalised with Covid in the West Country during that time had caught the virus from someone who was given a false negative test result.
So there is a degree of uncertainty, and mathematically, a range of numbers to estimate the impact of the testing scandal. The report said that this range, to a 95 per cent credibility level, showed that the number of additional cases could have been as low as 5,700 or as high as 34,100, and as many as 1,830 people could have been hospitalised with Covid as a result of the testing centre failures, and the number of additional people who died as a result of the scandal could be as high as 154.
However, on the latter figure they add: "Relatively small numbers of deaths leads to weaker fitting of the model to pre-incident data trends, compared to cases and hospitalisation, and hence the central estimate from the causal impact approach is notably different."
The report by UKHSA makes dozens of recommendations for the future so such a scandal does not happen again, many of which focus on inspections of laboratory practices, robustness of issuing contracts to testers, and responding more quickly to concerns expressed about testing processes from patients and health professionals, who were questioning whether someone was amiss with the test results in the West Country during September and into October.
Richard Gleave, UKHSA director and lead investigator, said: “Through this investigation we have looked carefully at the arrangements in place for overseeing contracts of private labs providing surge testing during this time. We have concluded that staff errors within Immensa’s Wolverhampton laboratory were the immediate cause of the incorrect reporting of COVID-19 PCR test results in September and October 2021.
“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. However, our report sets out clear recommendations to both reduce the risk of incidents like this happening again and ensure that concerns are addressed and investigated rapidly.”
The chief executive of UKHSA is Jenny Harries. She said she fully accepts the findings and recommendations of the report into the scandal. “UKHSA is committed to being a transparent, learning organisation and this means investigating where things have gone wrong and working out how things can be improved,” she said.
“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. We are particularly keen to further improve how we work with local partners and Directors of Public Health as rapid incidents like this unfold,” she added.
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