Immensa lab: month delay before incorrect Covid tests stopped
The government’s health watchdog knew about anomalous tests at a private laboratory that gave at least 43,000 people potentially false negative Covid results almost a month before it took action, it emerged.
The UK Health Security Agency (UKHSA) was alerted on 14 September this year to “an unusual spike” in the numbers of people testing positive on lateral flow tests, but negative on supposedly more accurate PCR tests processed by the Wolverhampton lab Immensa, court papers have shown.
According to a government response to a pre-legal action letter from the Good Law Project, the decision to stop the lab processing tests then only happened on 12 October.
NHS test and trace suspended testing operations at the Wolverhampton centre after investigating the anomalous results.
Test and trace said about 400,000 samples had been processed through the lab, the vast majority of which were negative results, but an estimated 43,000 people may have been given incorrect negative PCR test results, mostly in south-west England.
The UKHSA, the successor body to Public Health England, is considering legal action against Immensa. But separately, the Good Law Project has filed judicial review proceedings to, it said, “ensure the government addresses the multiple failures in their oversight of the Immensa lab”.
The organisation argues the lack of a proper system to monitor the accuracy of tests at such labs breached the Department of Health and Social Care’s duty to protect life, and the human rights of those affected.
Responding to the pre-action letter, the government legal department set out the background to the accreditation of testers, and the chronology for the Immensa site.
On 14 September, it said, UKHSA “was alerted to an unusual spike in the number of people testing positive
on lateral flow devices but negative on PCR tests”, and looked at possible causes including potentially faulty lateral flows and “any link to school-age children”, an apparent reference to the efforts by some students to create artificially false test results.
However, it was only on 12 October when “it was determined that the likely cause was a technical issue at the Immensa laboratory, and the laboratory ceased processing samples”.
Part of the Good Law Project’s judicial review effort is to seek better safety checks at private labs, arguing that the false negative results contributed to the spread of Covid in the south-west and put people in danger.
Jo Maugham, the director of Good Law Project, said: “A box-fresh unaccredited testing company was given a huge public contract; it then delivered tens of thousands of false negative test results.
“Ministers have failed to provide an account of what happened and to implement proper safety checks at private labs to prevent this ever happening again. With a tidal wave of Omicron sweeping the country people need to know that test and trace won’t fail to protect them and their families and friends again.”
Dr Will Welfare, the incident director for Covid at the UKHSA, said: “A full investigation remains ongoing and we will provide an update in due course; we 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.”