Blunder at COVID lab is linked to deaths of 20 people, investigators say

Twenty patients may have died due to a blunder over PCR tests at a scandal-hit Covid lab, health chiefs ruled today.

Errors at Immensa’s Wolverhampton site meant around 39,000 positive PCR swabs were wrongly logged as negative.

As a result, thousands continued with their daily lives and didn’t self-isolate — even though they were potentially infectious.

UK Health Security Agency (UKHSA) chiefs have now estimated the mistakes, which occurred in the autumn of 2021, led to about 55,000 extra cases.

Employees at Immensa Health Clinic in Wolverhampton were filmed fighting with each other (pictured) in January. This was at the height of the first wave and when the country was in strict lockdown

They estimated that each person who received a false negative went on to infect another two other people, on average.

Some would have taken measures to reduce their chance of spreading Covid, even though they weren’t told to self-isolate.

Researchers also estimated there were about 680 additional hospital admissions ‘that may not otherwise have occurred’.

‘Similarly, we estimate that there may have been just over 20 additional deaths in these most affected areas,’ they added.

NHS Test and Trace, the body in charge of Britain’s Covid swabbing programme, suspended testing operations provided by Immensa at its lab in Wolverhampton in October 2021 following reports of inaccurate results.

It has been one of the most enduring Covid conspiracy theories: that the ‘gold standard’ PCR tests used to diagnose the virus were picking up people who weren’t actually infected (stock photo)

Graphic shows: The step-by-step process for a PCR test completed via postal delivery

An investigation into the blunder concluded the error occurred because staff set the threshold levels for reporting positive and negative results incorrectly.

PCRs detect tiny fragments of Covid genes, known as RNA, in samples taken from the nose and throat. 

There is such a tiny amount of RNA on the swabs that it has to be amplified in a machine before it can be detected. 

This is done by repeating a cycle of heating and cooling, which encourages the genetic material to make copies of itself.

If someone tests positive at a low cycle threshold they are likely to have a lot of viral fragments present in their sample – because it doesn’t have to be amplified too many times to be detected – and very likely infectious.

The reverse is also true – a high cycle threshold can mean a positive result even if very little virus is present in the original sample.

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 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.’

Immensa missed Covid cases between Sep 2 and Oct 12, 2021. Affected patients — all of whom were contacted at the time — mostly lived in the south west. 

Top experts warned the testing error, initially blamed on ‘technical issues’, hit at the worst possible time. 

Daily cases were approaching peak second-wave levels and the booster programme was struggling to get off the mark ahead of a harsh winter.

Jenny Harries, UKHSA chief executive, said: ‘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.

‘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.’

Immensa was awarded a £119million contract in October 2020 to urgently ‘develop volume for PCR testing for Covid’.

It was not put out to tender under rules allowing urgent responses to the pandemic, meaning other companies did not have a chance to bid.

Another £50million was awarded to Immensa by the Government for additional PCR testing last summer.

The company, owned by Harvard University-educated Andrea Riposati, was only set up in May 2020, months before it was awarded the first deal by then-Matt Hancock’s Department of Health. 

Covid testers at the site were filmed fighting, playing football, sleeping and throwing snowballs in January, while the country was frozen under lockdown.