UK Clinical Laboratory Operations Suspended Following Reports of 43,000 False Negative COVID-19 PCR Test Results Over Five-Week Span
Medical laboratory company’s patients in Southwest England previously had tested positive for COVID-19 on a Lateral Flow Device
If providing accurate test results is key to maintaining trust with healthcare consumers, a private COVID-19 testing laboratory in the United Kingdom (UK) may have permanently damaged its reputation after reporting an estimated 43,000 false negative COVID-19 RT-PCR (polymerase chain reaction) test results over a five-week span between September 8, 2021, and October 12, 2021.
For now, Immensa Health Clinic Ltd., a subsidiary of DNA testing company Dante Labs, had its testing operations suspended on October 15 while the UK Health Security Agency (UKSA) investigates the cause of false negative PCR test results from the company’s lab in Wolverhampton, England. The test results went out to people who previously had tested positive for COVID-19 on a lateral flow device (LFD).
“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,” said Will Welfare, MBChB, Public Health Incident Director, UK Health Security Agency, in a UKHSA statement.
“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,” he added.
UK Government Officials Question How Lab Won Lucrative COVID-19 Testing Contracts
Immensa was awarded a £119 million (US$163.37 million) coronavirus testing contract by the British government in October 2020, just months after it was founded by Andrea Riposati, owner/CEO of Dante Labs, which has clinical laboratories in the UK, Italy, and the United Arab Emirates. The company’s corporate headquarters are in New York City while its scientific operations are based in the UK.
In “UK Ministers Face Questions over Firm Linked to Suspected COVID Test Errors,” The Guardian reported the private lab won an additional £50 million (US$68.6 million) contract from the UK Department of Health and Social Care (DHSC) last July.
NHS Test and Trace, the government program to track and help prevent the spread of COVID-19, has advised people who received the false test results, but who may still be infectious, to be retested.
In responding to the UKHSA’s action, Riposati pointed to Immensa’s track record and reiterated the laboratory’s emphasis on quality.
“We are fully collaborating with UKHSA on this matter. Quality is paramount for us,” Riposati said in the UKHSA statement. “We have proudly analyzed more than 2.5 million 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.”
Clinical Laboratories Not Accredited to Perform COVID-19 Testing
However, on October 18, 2021, The Guardian reported that the Immensa Health Clinic was not accredited by the UKAS, the UK’s independent accreditation service, before being appointed to perform COVID-19 testing. Dante Labs also has not been awarded UKAS accreditation, according to the newspaper report.
Government officials previously maintained that Immensa was “accredited to all of the appropriate standards.”
Immensa first made headlines in January 2021 when The Sun published an expose´ that included video of employees fighting, drinking, and bragging about watching porn while working at the clinical laboratory.
News of the testing failure at Immensa caused Tory MP Nigel Mills to tell The Sun, “This place should have been shut down for good when The Sun ran its [original] story. It is shocking it has been allowed to remain open and now there is an enormous mess.
“It’s a disgrace,” he added. “If shortcomings have emerged in the process here—which I strongly imagine they have—then heads should roll. The investigation should widen out and an audit should be carried out into other testing companies.”
Dante Labs Under Other Investigations
Immensa’s parent company, Dante Labs, is also under investigation in the UK due to concerns the company “may be treating its customers unfairly.”
A statement from the UK Competition and Markets Authority (CMA), outlined the UK government’s probe into Dante Labs. The statement cited the lab for:
- Potentially not delivering PCR tests and/or results on time or at all,
- Failing to respond to complaints or provide proper customer service,
- Refusing or delaying refunds when requested, and
- Providing terms and conditions that may unfairly limit consumers’ rights.
According to The Guardian, Dante Labs’ US operation also faced scrutiny in 2018 after the company admitting it had sent five used DNA test kits to people containing the saliva of other people. Dante Labs maintained its shipping company was the cause of the error.
US Labs Also Face Scrutiny over False Negative Test Results
Since the outbreak of SARS-CoV-2 in early 2020, there have been only a limited number of news accounts about clinical laboratories that reported a substantial number of inaccurate COVID-19 test results, either in the United States or the United Kingdom. In the US, there has been more news coverage of the federal Department of Justice (DOJ) prosecuting lab owners and related parties for submitting fraudulent claims for COVID-19 tests.
But the absence of those news accounts does not mean that there have been no incidents in the US where a lab testing company reported significant numbers of inaccurate COVID-19 test results.
In 2020, for example, Dark Daily reported on how Abbott Lab’s ID NOW COVID-19 rapid molecular test faced scrutiny over false negatives resulting in the FDA issuing a public warning about the point-of-care test’s accuracy after receiving 15 “adverse event reports” indicating some patients were receiving “false negative results.”
Then on June 22, 2020, KHN reported that the FDA had “received a total of 106 reports of adverse events for the Abbott test, a staggering increase. The agency has not received a single adverse event report for any other point-of-care tests meant to diagnose COVID-19.”
The UK lab’s failures are simply the latest example of how inaccurate test results erode the trust of healthcare consumers and draw the ire of politicians and government regulators. In this case, however, poor government oversight of a newly minted COVID-19 testing laboratory should face equal scrutiny.
—Andrea Downing Peck