, the Food and Drugs Administration has given a scathing review to rapid Covid tests on which the UK government has based its mass-testing programme. It said the test by California-based manufacturer Innova was not accurate enough.
In the UK, these lateral-flow Innova tests form the cornerstone of Operation Moonshot, the mass-testing scheme championed by the UK prime minister’s former chief adviserThe idea was that the ability to deliver results within 30 minutes – without the need for processing in a laboratory – provided a cheap, pragmatic and efficient way to identify people who had caught the virus but not fallen ill. But critics have raised concerns about accuracy.
The FDA said it has “ significant concerns that the performance of the test has not been adequately established, presenting a risk to health. In addition, labelling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests.
“ Finally, the test has not been authorised, cleared or approved by the FDA for commercial distribution or use in the United States, as required by law.”Meanwhile in Northern Ireland, the Department of Health has recorded a further 107 confirmed cases of Covid-19 in the last 24 hours, while no more Covid-related deaths were reported.Topics:
Isn't it weird with all the craic its been going on in dublin and other places for the past few weeks and the cases still ticking in below 500 i wonder why🤔
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