Discrepancies in Covid test results were spotted a month before testing was halted at one lab, court papers show.
More than 43,000 people received incorrect results after errors at the Immensa laboratory in Wolverhampton.
Many of those affected live in the south west of England.
Documents show the UK Health Security Agency (UKHSA) was alerted to the unusual figures on 14 September. Tests at the lab were suspended on 12 October and an investigation is ongoing.
The UKHSA said it “cannot comment on any information that could form part of these investigations before they are complete”.
“We suspended testing at the Immensa Wolverhampton laboratory following an ongoing investigation into positive LFD results subsequently testing negative on PCR.
“Those affected were contacted as soon as possible.”
Immensa said it was fully cooperating with the investigation.
“When did we become reliant upon citizens to check that box fresh companies, unaccredited with £120m of public contracts, are delivering?”
Test live samples
Concerns were raised when people with positive lateral flow test results received negative follow-up PCR results between 8 September and 12 October.
It is estimated that about 43,000 people may have been given incorrect results.
The errors led to people infected with Covid being mistakenly advised to stop isolating, increasing the risk of potentially infecting others.
The court documents showed Immensa was only required to routinely report tests that had produced no result, along with information about how fast the laboratory was turning tests around.
There were no checks to see how results compared with other laboratories – something that has since changed.
Andrew Preston, a microbiologist from the University of Bath said: “This is an issue that should have been flagged very soon after it started to arise, and then there should be procedures in place to at least know what’s going on – and say ‘hold on a minute’ and say ‘we need to go in’.
“And then in that case, if you have doubts over the veracity of your testing programme you cannot continue to test live samples if you are not convinced by the results.”
Campaign group The Good Law Project said many of the laboratory’s discrepancies had been discovered through social media.
It said: “When did we become reliant upon citizens to check that box fresh companies, unaccredited with £120m of public contracts, are delivering?”
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