IN THE UNITED KINGDOM, A MASS COVID-19 TESTING PLAN called “Operation Moonshot” is on hold until at least the end of January. Under the plan, health ministers sought to increase daily SARS-CoV-2 testing from 430,000 to 10 million Englanders per day.
Inaccurate early results from a newly-launched, same-day, at-home COVID-19 lateral-flow test caused officials to postpone that plan, according to published reports. Called the Innova SARS-CoV-2 Antigen Rapid Qualitative Test, the self-administered assay provides results in 30 minutes. However, a pilot test program among university students showed that the test missed 30% of cases among those who had a high viral load, according to The Guardian newspaper.
On Dec. 23, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) authorized the Department of Health and Social Care (DHSC) to use the antigen test for detecting COVID-19 infections in asymptomatic individuals.
Just two days earlier, health experts had questioned the accuracy of the test. Jon Deeks, PhD, CStat, Professor of Biostatistics at the Institute of Applied Health Research at the University of Birmingham, said his researchers used polymerase chain reaction testing to retest 10% (710 of the 7,189 university students) who had tested negative with the Innova test.
The PCR tests found six false-negative cases, raising the rate to 60 per 100,000, the British Medical Journal (BMJ) reported. Deeks leads the institute’s Biostatistics, Evidence Synthesis and Test Evaluation Research Group.
“We found two positives in 7,189 students, which scales up to 30 per 100,000 and was shocking in itself, as Birmingham has a rate of 250 cases per 100,000,” Deeks said. “The government should not be proceeding with plans for schools testing until they have a proper evaluation of the test.”
Universities in Bath, Birmingham, Bristol, Durham, Leeds, Leicester, and other cities used the assay to test students for SARS-CoV-2 ahead of the Christmas break, the newspaper added. From his assessment, Deeks estimated that 58% of the antigen tests produced false positives. Also, he said, the test has a low sensitivity level of about 3%, leading to false negatives.
‘Not Fit for Purpose’
About the lateral flow tests, The Tab, a London newspaper for students, quoted Deeks saying, “They’re not ready. They’re not fit for purpose. I’d rather hang these tests on a Christmas tree in Trafalgar Square. That would be better.”
The Guardian wrote, “The development is a blow to the UK government’s 100 billion pound ‘Operation Moonshot’ mass-testing plan, which aims to increase the number of COVID-19 tests done each day from 430,000 to 10 million.”
A DHSC spokeswoman called the antigen tests accurate and reliable for identifying asymptomatic individuals who have COVID-19. “The country’s leading scientists rigorously evaluated the lateral flow test and confirmed the accuracy of the tests using a sample of over 8,500. Latest figures for similar settings [are] showing sensitivity of 57.5% generally and 84.3% in people with high viral loads,” she stated.