FDA Authorizes Additional Indication for OTC COVID-19 Test

The Access Bio CareStart COVID-19 OTC Antigen Test can be used without a prescription; gives results in 10 minutes

If your email program has trouble displaying this email, view as a webpage. FDA Authorizes Additional Indication for Access Bio COVID-19 Over-the-Counter Antigen Test The U.S. Food and Drug Administration (FDA) reissued the emergency use authorization (EUA) for the Access Bio CareStart COVID-19 Antigen Home Test. The CareStart COVID-19 Antigen Home Test gives results in 10 minutes and can be used: Without a prescription. 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. For people 14 years of age and older with a self-collected nasal swab sample or 2 years of age and older when an adult collects the nasal swab sample. 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 FDA is committed to increasing the availability of appropriately accurate and reliable at-home COVID-19 diagnostic tests, and to facilitating consumer access to these tests. Read More Questions? If you have questions about OTC COVID-19 tests, see Coronavirus Disease 2019 Testing Basics.

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