On Nov. 22, 2021, the U.S. Food and Drug Administration (FDA) authorized another over-the-counter (OTC) COVID-19 antigen test. 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.

This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.

The SARS-CoV-2 nucleocapsid protein antigen is generally detectable in anterior nasal (nares) swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with your product should self-isolate and seek follow up care with their physician or healthcare provider as additional testing may be necessary.