A Valuable Public Health Tool with Limited Relevance to Individuals

/PMC7836413

  • #COVID-19 Antibody Tests : A Valuable Public Health Tool with Limited Relevance to Individuals
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7836413

    Entre autres raisons (aux #Etats-Unis) :

    Non seulement plusieurs tests restent autorisés par la #FDA malgré la preuve de leur mauvaise qualité…

    Independent validation studies indicated many tests were of poor quality, which led to media attention and Congressional hearings […]

    […]

    Inaccurate tests are still in use; yet, there have been no recalls. Though some major biotechnology companies have stopped selling tests following poor independent validation studies, the FDA issued guidance revoking Emergency Use Authorization (EUA) for just two tests

    … mais en plus plusieurs tests non autorisés sont utilisés !

    Some test manufacturers fraudulently claimed FDA approval for their tests. Independent research groups have led the way in monitoring evaluations of antibody tests [23., 24., 25., 26.]. The FDA now maintains a list of tests that have not received EUA and that should not be distributed, now including 155 serology tests, but this information is not prominently displayed [27]. The lack of clear messaging on FDA EUA status has led to the use of potentially inaccurate tests [28].

    #sérologie #sars-cov2 #tests #anticorps