British Laboratory Covid Test Failures “Should Have Been Reported Within Days” | Coronavirus

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Health officials should have been aware of major failures of a private Covid testing lab within days of the problem occurring, rather than taking weeks to shut down operations at the site, according to senior scientists.

Around 43,000 people, mostly in the south-west of England, were reportedly falsely told they did not have the virus by the laboratory at Immensa Health Clinic in Wolverhampton in a debacle described as one of the UK Covid Crisis Worst Scandals.

The affected swabs were processed from September 2, but neither Immensa’s own quality control processes nor UK Health Safety Agency (UKHSA) oversight sounded the alarm before members concerned public did not complain, triggering a formal investigation.

“In the long list of Covid disasters and scandals, it’s pretty close to the top,” said Alan McNally, professor of evolutionary microbial genomics at the University of Birmingham, who helped set up the test lab. Lighthouse Covid in Milton Keynes.

“You shouldn’t rely on anecdotal reports to spot a problem of this magnitude. It’s the unforgivable thing about it, ”he added. “I don’t think it’s too much to say that an absolute failure of quality in this lab is going to lead to very serious illness, maybe hospitalizations, and maybe worse.”

The UKHSA suspended work at the Immensa lab on October 12, at least three weeks after academics and others raised concerns about discrepancies in regional data from Covid testing.

The failure prompted the government to publish its contract with Immensa, transfer as many tests as possible to the NHS and university labs, and establish tighter oversight of the hundreds of private companies that have rushed into the testing industry Covid, often without any experience in performing critical clinical tests.

A UK researcher who is familiar with Covid testing, but is not authorized to comment on the matter, said problems at Immensa were almost inevitable given how private companies have been asked to build capacity test.

“This commercial capacity has multiplied in a very short period of time and that’s because it was allowed and encouraged, and there was very little oversight,” they said. “The technology is so routine that almost anyone with a lab experience can do it.

“The fact that companies are being created and performing potentially unreliable testing is not surprising, because you created the market opportunity for it to happen. “

Tests that were said to have been sent to Immensa’s laboratory in Wolverhampton are being diverted to other companies, and people who have received potentially false negative results have been asked to test again.

Sensitive PCR tests used to analyze Covid swabs have built-in controls that should immediately report failed tests to the operator. Results from PCR machines are usually interpreted by computer software, so good labs tend to check data manually for unusual patterns such as prolonged periods without positive results.

“If it wasn’t collected internally, the only conclusion I can come to, after overseeing a million and a half of these tests, is that no one was looking at the data from the PCR machine,” McNally said.

Deenan Pillay, professor of virology at University College London and a member of the Independent Sage group, said the Department of Health and Welfare (DHSC) must publish its contract with Immensa so that the written quality control measures in the document can be reviewed.

He said as much of the private testing as possible should be shifted to the NHS and university labs where quality control is built in and lab heads take responsibility for the reliability of testing.

“What really amazes me is that a problem like this was not detected in the lab almost the same day,” he said. “If something seems strange, even though the number of positive tests is decreasing, then that’s a clear red flag.

“Mistakes always happen in laboratories. This is why you have put in place a whole series of systems to quickly identify any problem.

This week, a DHSC spokesperson claimed that the Immensa lab was “fully accredited by the UK’s Independent Accreditation Service (Ukas) prior to being appointed”, but Ukas was quick to make it clear that he didn’t had never accredited Immensa or its sister company, Dante Labs.

The UKHSA on Friday said it was previously incorrect to say that the problem started on September 8 and actually arose six days earlier.

“The consequences of a false negative result are very alarming. You become a danger to those around you, to the people you love, ”said the researcher familiar with Covid tests. ‘I’m sure there would have been obstacles to expanding the capacity of the NHS, but I think that was the way to go, and it would have greatly avoided what we got, which is complete freedom for all and an apparent blow. -on the effect on the quality.

“What is the point of doing clinical tests if they are not robust, if they are not well controlled? If that doesn’t create an appropriate stench, what do we say? That it’s okay to run a whole bunch of tests that give results that aren’t worth getting? “

With the high number of cases in the UK, McNally said it might make sense to ditch PCR testing in favor of lateral flow testing. “Why continue to use this huge amount of taxpayer money to provide PCR testing for an infection that the government is doing nothing to control? It makes no sense, ”he said. “We can use the huge testing budget for something that could make a difference, like supporting people who need to be isolated. “

Dr Will Welfare, director of incidents for Covid-19 at UKHSA, said the investigation into Immensa was ongoing. “There is no evidence of faults with the lateral flow devices or the PCR test kits themselves and the public should remain confident in their use and other laboratory services currently provided.”

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