US health agency gives lateral flow Covid tests scathing report

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Sumary of US health agency gives lateral flow Covid tests scathing report:

  • The US Food and Drug Agency (FDA) has raised significant concerns about the rapid Covid test on which the UK government has based its multibillion-pound mass-testing programme..
  • In a scathing review, the US health agency suggested the performance of the test had not been established, presenting a risk to health, and that the tests should be thrown in the bin or returned to its California-based manufacturer Innova..
  • In the UK, these lateral flow Innova tests form the cornerstone of Operation Moonshot, the mass-testing scheme championed by the prime minister former chief adviser..
  • Given the tests have been offered free to millions in England, for use at home or at test centres, workplaces and schools, with the aim of detecting more cases, breaking chains of transmission and saving lives since April – the FDA announcement is particularly damning..
  • The US agency has not authorised the use of the Innova test in the US, although the manufacturer has submitted a request for authorisation..
  • But when the FDA discovered the Innova test was being distributed for US use regardless, it conducted an inspection of Innova medical device operations between March and April 2021..
  • The FDA also highlighted that the clinical study data submitted by Innova as part of its request for US authorisation was identical to data previously provided by other manufacturers in separate requests..
  • The accuracy of the Innova tests also falls dramatically when administered by self-trained, non-healthcare workers versus lab scientists….

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