Health chiefs have launched an urgent probe into the PCR testing network after a blunder at a Wolverhampton lab saw up to 45,000 Covid-infected Britons wrongly told they did not have the virus.
Dr Jenny Harries, the head of the UK Health Security Agency, said a ‘few thousand’ of the missed cases – mostly in the South West – were likely still infectious. People in the South East and Wales are also known to be affected.
She said a ‘serious incident investigation’ was launched to ‘make sure if there are any further problems with other laboratories we can absolutely spot them as quickly as possible’.
Boris Johnson told reporters on a visit to Bristol that officials were still ‘looking into’ what went wrong at the testing centre. But the Prime Minister insisted that the fiasco did not affect ‘overall’ cases numbers.
However Kit Yates, a senior lecturer at the University of Bath and a member of the Independent Sage scientific advisory group, warned that knowing the number of false negatives doesn’t ‘come near to the cost of the mistake’.
He added: ‘Many of these people will have been forced into school or work, potentially infecting others.
‘This could be part of the reason behind some of the recent rises we’ve seen. It’s really important that we’ve had lateral flow tests which, at the very least, allowed us to understand there was an issue even if people weren’t allowed to act on the results.
‘We need to find out exactly what happened here in order to make sure it doesn’t happen again elsewhere.’
Immensa Health Clinic was last year given a £120million contract by the Government to analyse PCR tests from centres across the South West. The firm was given another £50million in a renewal deal that went through in July.
But today its Covid testing operation was suspended after an investigation revealed the lab had incorrectly analysed tens of thousands of PCR swabs, in a blunder dating back to September 8.
Covid testers at the site were filmed fighting, playing football, sleeping and throwing snowballs in January, while the country was frozen under lockdown.
Professor Alan McNally, a microbiologist at Birmingham University, said he ‘cannot fathom’ how so man tests had been mixed up. He said there were likely so many errors because appropriate controls were ‘not being used’.
Immensa’s Harvard Business School-educated Italian CEO Andrea Riposati claimed he was fully co-operating with authorities and insisted that ‘quality is paramount’ for the firm.
The company was only set up last May, just months before it was awarded the first deal by then-Matt Hancock’s Department of Health. It is owned by Dante Labs, which is currently under investigation for failing to deliver day-two and day-eight PCR tests on time and issue customers refunds.
The testing fiasco was only uncovered following an urgent probe into the accuracy of PCR tests, after thousands complained they tested positive with lateral flows only to get a negative result from the gold-standard PCR process.
Scientists today appealed to Britons to keep taking PCR tests, saying that this was an isolated issue at one laboratory.
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 were also recorded playing football together at the testing centre while on duty
Immensa Health Clinic, in Wolverhampton, has been suspended following an investigation revealing it may have incorrectly processed PCR tests. The lab (pictured) has been paid £120million by the taxpayer for its services
Latest Test and Trace data shows 16 per cent of secondary school children in England who tested positive using a rapid test in the week to October 6, were found to be negative for the virus after they took a PCR
This graph shows the number of PCR tests (blue bars) carried out in the UK daily. There are currently more than 400,000 swabs analysed daily, which is about half of capacity (grey area)
Graphic shows: The step-by-step process for a PCR test completed via postal delivery
West Berkshire Council called for them to visit Newbury Showground (pictured) for another test
The UK Health Security Agency, which took over from the now-defunct PHE, is still trying to work out exactly what went wrong. Health bosses ruled out the issue being down to faulty tests, however.
West Berkshire council today urged everyone tested at one of its sites between October 3 and 12 to get a second swab.
Dr Harries told the BBC anyone affected by the swabbing issue would be contacted by Test and Trace, with those whose tests were processed in the last ten days a priority.
Q&A: Everything you need to know about Immensa Health Clinic
How many tests does it carry out?
Officials said Immensa has done more than 400,000 swabs since September 8, which was equivalent to about 11,400 a day.
The company says online that it has completed more than three million Covid tests at its Wolverhampton site since it was founded in May last year.
Who was affected by the blunder?
Some 45,000 Britons may have been given the wrong Covid results, officials said.
The site mainly processes PCR swabs from centres in the South West, but also checks tests from other parts of the country.
What caused the testing error?
Officials are still baffled as to what triggered the error in PCR tests at present.
But analysing each swab for the virus involves several steps and complex machinery.
What goes on inside the lab?
Once a Covid swab arrives at the lab it is processed by technicians to see whether it contains Covid.
But leaked footage has shown employees fighting at the lab in January at the height of the second wave.
Does it process holiday PCR tests too?
The lab is not thought to process holiday tests.
But Immensa Health Clinic is owned by Dante Labs, which offers day-two and day-eight tests to people arriving in the UK.
It is currently under investigation after regulators were told it was failing to deliver Covid tests to customers and issue refunds.
‘We will be contacting by text message, by email… and will recommend they have another test,’ she said.
But others will still be contacted because ‘we clearly want to acknowledge that there has been a problem with that lab and just let them know’.
She warned a ‘few thousand’ people who were missed in the blunder were likely still infectious.
‘The period of real infectivity is probably only reaching back about six or seven days… so I think it will only be a few thousand people who will have positive tests in that total number,’ she said.
‘It is very difficult to estimate. So we are obviously being cautious and just sending a message to all of them.’
Dr Harries explained officials were able to spot the issue because of the geography of the false negatives and the timing, allowing them to zoom in on the lab.
Asked when they became aware of the issue, Dr Harries said there had been ‘some feedback and some queries coming through over the last two or three weeks’.
‘But it is only in the last few days when we have dug right down into both the geography and the different type of tests coming back through and the different prevalence rates that’s allowed us to pinpoint exactly what it is.
‘About half of these cases are coming from the South West, and that has allowed us to locate the laboratory.’
Speaking at a visit to a Rolls Royce factory in Bristol, Mr Johnson said: ‘We’re looking into what went wrong with that particular testing centre, but it doesn’t affect overall numbers.
‘Overall, the picture in the South West in the Bristol area and the rest of the country, remains very much where it has been for some time now.
‘We are just getting along in a state of, more or less, an equilibrium.’
Mr Johnson added that while infection rates were high, particularly in school children, it ‘isn’t really feeding through into the older generations in the way that we saw in previous spikes’.
‘There’s no doubt that the wall of vaccination that the country has built is very high and very effective.’
Professor McNally expressed his amazement at tens of thousands of tests being possibly wrongly diagnosed.
He told the BBC: ‘If you do that test properly with all the appropriate controls then there is no way you should have missed the sheer volume of false negative results we are talking about here. You should have see if you have this level of systematic failure.’
He added: ‘I cannot fathom the failings that would lead to this level of false negative results.’
Dr Will Welfare, the public health incident director at the UKHSA, said the lab had been investigated following concerns over its test results.
He said: ‘We have recently seen a rising number of positive LFD results subsequently testing negative on PCR.
‘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.
‘We have immediately suspended testing at this laboratory while we continue the investigation.’
He added: ‘There is no evidence of any faults with LFD or PCR test kits themselves and the public should remain confident in using them and in other laboratory services currently provided.
Harvard Business School-educated CEO of Immensa Health Clinic Andrea Riposati (pictured) said he was fully co-operating with authorities and that ‘quality is paramount’. He is also the head of Dante Labs, which owns Immensa
Immensa labs are located at Wolverhampton University’s science park. The university confirmed in a statement that the company operates from the location
Pictured is a Covid testing centre next to the science park at Wolverhampton University
Who IS Andrea Riposati? The Harvard-educated Italian CEO of Dante labs and Immensa
Andrea Riposati is chief executive of Dante Labs
Andrea Riposati is the man behind Dante Labs, which owns Immensa.
Details of his past are scarce but he started his career in management consultancy and only became involved in genomic sequencing five years ago.
Graduating from Harvard Business School in 2009, the Italian, now 40, joined Amazon as a product manager in the company’s business-to-business arm in 2011.
In 2013 he became head of 3D-printing at the company before leaving the following year.
He joined data analytics firm Muse Technologies as chairman in 2014 and became chief executive of Dante Labs in 2016.
He founded the genome-sequencing company with a friend — Mattia Capulli, who is now the firm’s chief scientific officer.
It had previously specialised in sequencing ‘100 per cent of your DNA’ to help highlight vulnerabilities to genetic diseases.
The company, based in L’Aquila, Italy, has analysed 2.5million Covid PCR tests via its Immensa platform, it says.
But Immensa Health Clinic, the firm behind the wrong 45,000 tests that received a £119million grant last year, has only existed since March 2020.
It is not clear whether Mr Riposati has links to Matt Hancock or any other Government minister.
‘If you get a positive LFD test, it’s important to make sure that you then get a follow up PCR test to confirm you have Covid. If you have symptoms of Covid, self-isolate and take a PCR test.’
Officials said some 400,000 tests had been processed by the lab since September 8 – the equivalent of around 12,000 every day.
But they said the majority of these would have tested negative.
Around 7 per cent of PCR tests carried out detect the virus, according to official figures.
And NHS Test and Trace officials claim around 800,000 PCR swabs are taken each day across the country.
The 43,000 people who may have been given an incorrect result will be contacted in the coming days to get a second test, officials said.
Samples that were headed for the lab are being redirected to other testing centres dotted across the country.
Britain has seven Lighthouse laboratories for analysing PCR tests, alongside dozens of other sites in universities, hospitals and private companies.
Immensa Health Clinic won a £119million Government contract in November last year to carry out PCR tests.
This was not put out to tender, meaning other companies did not have a chance to bid for the deal.
It was awarded a further £50million by the Government in a contract in July.
According to the Immensa website, the firm was new to Covid testing. It said: ‘In 2020, we adapted and evolved into Covid testing, taking advantage of our laboratory network, scientific expertise, and digital systems to deliver world-leading Covid testing solutions.’
Immensa is owned by Italy-based Dante Labs, which has operations in Wolverhampton and Cambridge as well as Dubai and Italy.
The company can carry out up to 50,000 Covid tests a day, Mr Riposati wrote on its social media.
It offers day-two and day-eight PCR tests for people who arrive in the UK, day-five test-to-release kits and ‘fit to fly’ swabs.
But the company is currently the subject of an investigation by the Competition and Markets Authority (CMA).
The CMA said it had received reports that the ‘popular’ business was failing to deliver PCR tests on time or at all, respond to customer complaints and to issue people with refunds.
The watchdog added Dante Labs may be using terms and conditions which unfairly limited consumers’ rights.
Government sources say that travel tests are thought to be unaffected by the blunder at the lab. They can still be bought from £39.
Undercover footage showed employees at the centre fighting, playing football, throwing snowballs and sleeping during their shifts in January.
A source told the Sun on Sunday: ‘Testing is the way out of this horrific situation the country finds itself in and it’s a disaster at that site.
‘The company has been handed a multi-million pound contract for the staff to just mess around and potentially ruin thousands of tests.’
The Department of Health said at the time it took evidence of misconduct ‘extremely seriously’ and would investigate. Immensa did not respond to requests for comment.
Transport Secretary Grant Shapps rules out lockdown over festive period as cases hit a three-month high
Grant Shapps has ruled out another Covid lockdown over Christmas as cases hit a three-month high.
The Transport Secretary said there will ‘be no issues’ with seeing loved ones around the festive period this year.
No10 introduced tough restrictions which stopped millions from seeing their families last December, despite Boris Johnson dismissing the possibility of Christmas being cancelled repeatedly before the move.
Scientists have warned the NHS could be overwhelmed again this winter, with cases reaching 45,066 yesterday, the highest new daily total since July 20.
Professor Chris Whitty yesterday claimed this winter will be ‘exceptionally difficult’ for the NHS even if there is not a surge of infections. He said he could not claim it will be ‘all be fantastic by Christmas’.
England’s chief medical officer warned of tough months ahead for the health service as it battles Covid, flu and other seasonal viruses which are enjoying a resurgence due to a lack of natural immunity during lockdowns.
But Mr Shapps dismissed concerns Britain could be plunged into another lockdown around Christmas again.
He told Sky News: ‘With Christmas last year we were worried about being able to see loved ones and families.
‘There will be no issues with that this year.
‘And we’ll make sure that the supply chain is doing what it should be doing, which is what these measures that we’re taking, including this alteration to this cabotage today is designed to do.’
Mr Riposati, who also leads Immensa labs, said: ‘We are fully collaborating with UKHSA on this matter. Quality is paramount for us.
‘We have proudly analyzed more than 2.5million samples for NHS Test and Trace, working closely with the great teams at DHSC and UKHSA.
‘We do not wish this matter or anything else to tarnish the amazing work done by the UK in this pandemic.’
A spokeswoman for Wolverhampton University said in a statement: ‘I can confirm Immensa Health Clinic is one of the tenants at the University of Wolverhampton Science Park.
‘The University of Wolverhampton and the University of Wolverhampton Science Park Ltd are not involved in the work of the company.’
Scientists today appealed for Britons to continue to get PCR tests, pointing out that the UK’s Covid testing system was built at pace.
Professor Alexander Edwards, a biomedical technology scientist at Reading University, said: ‘Let’s not throw the baby out with the bathwater.
‘The vast majority of tests are correct, and it’s worth remembering that our testing system has been built up from almost nothing at the start of the pandemic.
‘I am genuinely amazed by this expansion of testing, and I applaud the hard work that has gone in on so many levels.
‘Many people dropped everything they were doing to focus fully on high-quality, scientifically sound testing, and following months of incredibly hard work have not received the same appreciation showered on vaccine workers.
‘Please let’s not assume all problems or failures mean that all testing is bad.’
But there are growing signs that Britons are now feeling uneasy about the accuracy of Covid tests.
Tim Barton, 48, from Swindon in the South West said he and his family got positive lateral flow tests after falling ill with Covid symptoms earlier this month.
But when they went for a PCR swab they all tested negative for the virus.
The client relationship director said he feared that issues at the Immensa laboratory may be behind the diagnosis.
He added: ‘My son, daughter and myself all had positive (lateral flow tests) — we then had PCR tests done at the test site in Swindon all of which came back negative.
‘This will undoubtedly impact people’s confidence in the accuracy of these types of tests… they could have cost lives.’
Concerns had been raised over the accuracy of lateral flow tests amid a surge in the number of secndary school children thought to be getting ‘false positives’.
This is when a child tests positive for the virus using the rapid swabs, but then gets a negative result from a PCR.
Test and Trace figures show that just six per cent of school children were getting false positives in the week to September 8, when schools returned.
But in the latest week some 13 per cent got false positives, almost double the original number.
Lateral flow tests are generally regarded as less accurate than gold-standard PCR tests.
Scientists have warned that the tests can produce the wrong results if they are not carried out correctly.
A man is pictured on the phone at the Covid testing centre next to Wolverhampton University science park, where Immensa labs are based
Meaghan Kill, an epidemiologist at the UKHSA, said on Twitter: ‘If you had a positive LFD between September 8 and October 12, you probably had Covid regardless of your PCR result.
‘No fault has been found in LFD test kits.
‘False positive LFDs are rare (3 in 10,000) especially when prevalence of Covid is high. Trust your LFD.’
West Berkshire council announced this morning it had been made aware of problems with Covid test results for swabs taken at one of its sites.
It said in a statement: ‘After receiving reports from local residents in recent weeks that there were concerns about the accuracy of test results from (Newbury Showground test site), we passed these concerns onto the DHSC for further investigation.
‘The DHSC has now confirmed that a number of sites nationally may have been affected by this issue, including the one at Newbury Showground.’
The Covid testing centre, based at the events venue on the outskirts of the historic market town, is run by the government.
Sites like this dish out the majority of PCR tests, with samples sent to labs for analysis before results are sent back by text or email.
Ministers aim to return all results within 24 hours, although in some cases it can take as long as 72 to get a diagnosis.
Councillor Graham Bridgman told the Sun: ‘We are aware there was an issue with some tests undertaken at Newbury Showground earlier this month, which has now been resolved.
‘We would urge any residents that are concerned about their results to book another test as soon as possible so we can continue to prevent the spread of the virus across the district.’
There have been reports across the South West of England of lateral flow tests giving them negative results before PCR tests say they are positive.
So why DID Immensa get awarded its huge health contract? Firm was only months old with no known connection to viral testing
Immensa Health Clinic was awarded the £119million contract in October last year to carry out coronavirus testing.
It was huge coup for the firm, which only came into existence back on May 18 that year.
The deal was never put out to tender so it is unclear as to why it was selected for such a lucrative contract.
Immensa’s only director is Andrea Riposati, 40, whose background is actually in businesses specialising in genome sequencing.
His previous jobs have included working in Artificial Intelligence at Amazon.
Immensa was awarded a further £50million by the Government in a contract in July
Immensa had previously said its address was at a co-working office space in London’s Victoria area, with not enough room to manufacture anything in large quantities.
But in August it registered a new address in Lansdowne House in Mayfair.
Even when it was first started up, it did not seem to have designs in virus testing.
The overview of the companies activities lists ‘Research and experimental development on biotechnology’ and ‘Other human health activities’.