FDA Authorizes 3 OTC COVID-19 Tests

11/23/21 — 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. These tests are:

• 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, or a serial test for people without symptoms, meaning the test is done two times over three days.
• 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, or as a serial test for people without COVID-19 symptoms, meaning the test must be done twice over three days.
• BD Veritor At-Home COVID-19 Test gives results in 15 minutes. The test can be used as a single test for people with COVDI-19 symptoms, or as a serial test for people without COVID-19 symptoms, meaning the test must be done twice over three days.

Read the FDA announcement.