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

• More rapid antigen tests approved (FDA)

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.