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FDA authorizes over-the-counter screening tests for COVID-19

Posted by skybrian
Tags: usa, fda, coronaviruses.covid19, testing.covid
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-advance-over-counter-and-other-screening-test-development

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Title
Coronavirus (COVID-19) Update: FDA Continues to Advance Over-the Counter and Other Screening Test Development
Published
Mar 31 2021
Word count
552 words

1 comment

  1. skybrian
    (edited )
    Link
    From the article: Via Michael Mina. At least some of these are apparently paper-strip antigen tests.

    From the article:

    In total, the FDA has authorized three tests with serial screening claims (testing asymptomatic individuals multiple times on a routine basis). Specific tests authorized this week:

    • Quidel QuickVue At-Home OTC COVID-19 test - authorized for OTC at-home serial screening
    • Abbott BinaxNOW (multiple configurations)
      • Abbott BinaxNOW COVID-19 Antigen Self Test – authorized for OTC at-home serial screening
      • Abbott BinaxNOW COVID-19 Ag Card 2 Home Test - authorized for OTC at-home serial screening with telehealth proctor
      • Abbott BinaxNOW COVID-19 Ag 2 Card – authorized for POC serial screening without a prescription
    • BD Veritor System for Rapid Detection of SARS-CoV-2 – authorized for POC serial screening with a prescription

    These tests had been previously authorized by the agency (some under different names) to test those with COVID-19 symptoms, but the actions this week authorize testing of asymptomatic individuals when used for serial testing.

    Via Michael Mina. At least some of these are apparently paper-strip antigen tests.

    1 vote