FDA Authorizes InBios COVID-19 Over-the-Counter Antigen Test The U.S. Food and Drug Administration (FDA) authorized another over-the-counter (OTC) COVID-19 antigen test. 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. The FDA issued an emergency use authorization (EUA) for the InBios SCoV-2 Ag Detect Rapid Self-Test, an OTC COVID-19 antigen diagnostic test that 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 test can be used for people: - Age 14 years or older with a self-collected nasal swab sample.
- Age 2 years or older when an adult collects the nasal swab sample.
Questions? If you have questions about OTC COVID-19 tests, see Coronavirus Disease 2019 Testing Basics. |
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