Covid test failure in UK lab must be reported within days of coronavirus

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Leading scientists said health officials should have learned about major failures at a private Covid testing lab within days of the problem emerging, rather than taking weeks to shut down on-site operations.

About 43,000 people, mostly in south-west England, are believed to have been wrongly told they did not have the virus by the Immensa Health Clinic lab in Wolverhampton in a disaster described as one of the worst scandals in the UK’s Covid crisis.

Affected swabs were processed as of 2 September, but neither Immensa’s quality control operations nor oversight from the UK Health Security Agency (UKHSA) raised the alarm before a complaint from the concerned public was filed, prompting a formal investigation.

“In the long list of Covid disasters and scandals, this is very close to the top,” said Alan McNally, professor of microbial evolutionary genomics at the University of Birmingham, who helped set up the Lighthouse Covid testing laboratory in Milton Keynes.

You should not rely on anecdotal reports to identify a problem of this magnitude. That’s the unforgivable thing about this.” “I don’t think it would be an exaggeration to say that an absolute failure of quality in this lab would lead to very serious illnesses, perhaps hospitalization, and perhaps worse.”

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

The failure prompted calls for the government to publicize its contract with Immensa, divert as much testing as possible to the NHS and university labs, and establish stricter oversight of the hundreds of private companies that have rushed into the Covid testing field, often without action. Proven track record of delivering critical clinical tests.

One British researcher familiar with Covid testing, but not authorized to speak on the issue, said problems at Immensa were almost inevitable given the way private companies were brought in to build testing capabilities.

They said, “This commercial ability has spread in a very short time and that is because it was allowed and encouraged, and there was very little oversight.” “The technology is so routine now that almost anyone with lab experience can do it.

“The fact that you have companies under construction and doing potentially unreliable testing is not surprising because you created the market opportunity to make that happen.”

Tests that could have been sent to Immensa’s Wolverhampton Laboratory are being diverted to other companies, and individuals who received possible false negative results were advised to take the test again.

The sensitive PCR tests used to analyze Covid swabs have built-in controls that should indicate failed tests to the operator immediately. Results from PCR machines are usually interpreted by computer software, so good labs tend to manually check the data for unusual patterns such as long periods with no positives.

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

Dinan Pillay, a professor of virology at University College London and a member of the Sage Independent group, said the Department of Health and Social Care (DHSC) should publicize its contract with Immensa so that the quality control procedures written in the document could be scrutinized.

He said as much private testing as possible should be transferred to the NHS and university labs where quality control is built in, and lab chiefs are responsible for the reliability of the test.

“What really surprises me is that a problem like this was not detected in the lab around the same day,” he said. “If anything seems odd, even if the number of positive tests goes down, that’s a clear red flag.

“Errors always happen in labs. That is why you have a whole series of systems in place to quickly identify any problems.”

This week, a DHSC spokesperson claimed that Immensa’s lab was “fully accredited by the UK’s independent accreditation service (Ukas) prior to its appointment”, but Ukas quickly clarified that it has never accredited Immensa nor its sister company Dante Labs.

On Friday, the UKHSA said it had previously been wrong to say the problem started on September 8, and that it actually arose six days earlier.

“The consequences of a false negative result are very worrying. You become a danger to those around you, to the people you love,” said the researcher familiar with the Covid test. “I am sure there could have been obstacles to expanding NHS capacity, but I think this is the way to go, and would have pretty much avoided what we had, a free-for-all and a clear-cut effect on quality.

“What is the point of doing clinical tests if they are not robust, if they are not properly controlled? If this does not create a proper bad odor, what shall we say? Is it okay to run a whole load of tests that give results that are not worth undergoing?”

With UK cases on the rise, McNally said it might make sense to forego PCR testing in favor of lateral flow tests. “Why keep using this huge amount of taxpayer money to provide PCR tests for an infection that the government is doing nothing to control? It makes no sense,” he said. “We could use this massive testing budget for something that might make a difference, like supporting people who need isolation.”

Dr Will Welver, UKHSA’s Covid-19 incident manager, said the investigation into Immensa was continuing. “There is no evidence of any defects in the lateral flow devices or the PCR test kits themselves and the public should remain confident in their use and in other laboratory services currently available.”

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