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More rapid antigen tests approved (FDA) (November 23, 2021)

(2021-11-27 13:25:29) 下一個

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-november-23-2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • On Nov. 22, the FDA authorized three over-the-counter (OTC) COVID-19 antigen diagnostic tests for people age 14 years or older with a self-collected nasal swab sample or people age 2 years or older when an adult collects the nasal swab sample.
    • The InBios SCoV-2 Ag Detect Rapid Self-Test delivers results in about 20 minutes. The test can be used as:
      • A single test for people with COVID-19 symptoms within the first five days of symptom onset.
      • A serial test for people without symptoms, meaning the test is done two times over three days.
    • The Access Bio CareStart COVID-19 Antigen Home Test gives results in 10 minutes. The test can be used:
      • As a single test for people with COVID-19 symptoms.
      • As a serial test for people without COVID-19 symptoms, meaning the test must be done twice over three days.

      The FDA reissued the EUA to authorize use of CareStart COVID-19 Antigen Home Test as a single test without a prescription for people with COVID-19 symptoms. The test was already authorized for use as a serial test without a prescription by people with or without symptoms.
    • The Becton, Dickinson and Company BD Veritor At-Home COVID-19 Test gives results in 15 minutes. The test can be used:
      • As a single test for people with COVID-19 symptoms.
      • As a serial test for people without COVID-19 symptoms, meaning the test must be done twice over three days.

      The FDA reissued the EUA to authorize use of the BD Veritor At-Home COVID-19 Test as a single test without a prescription for people with COVID-19 symptoms. The test was already authorized for use as a serial test without a prescription by people with or without COVID-19 symptoms.
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