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UK Government Suspends SARS-CoV-2 PCR Testing at Laboratory Due to Potential Erroneous Results

NEW YORK ─ The UK government has suspended testing by Immensa Health Clinic at its laboratory in Wolverhampton, following an investigation into reports of people receiving a negative PCR test result after they had previously tested positive using a lateral flow device, or LFD.

The vast majority of about 400,000 samples processed through the lab tested negative, according to estimates by the government's NHS Test and Trace program, but an estimated 43,000 people may have been given incorrect negative PCR test results between Sept. 8 and Oct. 12, mostly in the Southwest of England, prompting the suspension of testing.

Investigations are underway into the precise cause of the problem.

"We have recently seen a rising number of positive LFD results subsequently testing negative on PCR," Will Welfare, public health incident director of the UK Health Security Agency, said in a statement, adding, "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."

The agency is working with NHS Test and Trace and Immensa to identify lab-based technical issues that led to inaccurate PCR results, he said.

Immensa Health Clinic is not the only UK company to be investigated by the government over SARS-CoV-2 testing. In September, the UK's Competition and Markets Authority said it has opened an investigation into a company following complaints that it did not provide COVID-19 test results in a timely manner or at all.

The government is also cracking down on potential price gouging and substandard delivery of domestic PCR-based testing services for SARS-CoV-2.

Meanwhile, the UK government has also been criticized over its management of SARS-CoV-2 testing. In June, the National Audit Office, a UK public spending watchdog, released a follow-up report that heavily criticized the region's test-and-trace program for COVID-19, saying that only a small proportion of distributed lateral flow tests have been registered as used. Also in June, Bedford, UK-based diagnostic test developer Mologic announced that it had sued the UK government over the validation of its rapid antigen test for SARS-CoV-2.