30-Minute COVID-19 Rapid Test Authorized

The U.S. Food and Drug Administration (FDA) reissued an emergency use authorization (EUA) for the OraSure Technologies InteliSwab COVID-19 Rapid Test on November 1, 2021.

The InteliSwab COVID-19 Rapid Test gives results in 30 minutes.

The FDA authorized the InteliSwab COVID-19 Rapid 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 and as a single-use test with a prescription for symptomatic people suspected of COVID-19 by their healthcare provider.

Indications: Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 with:

• Self-collected anterior nasal (nares) swab samples from individuals aged 18 years or older with symptoms of COVID-19 within the first seven days of symptom onset.
• Adult-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first seven days of symptom onset.
• Self-collected anterior nasal (nares) swab samples from individuals aged 18 years or older, or adult collected anterior nasal swab samples from individuals aged 15 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 FDA is committed to helping increase the availability of accurate and reliable at-home COVID-19 diagnostic tests and facilitating consumer access to these tests.

As of early November 2021, the FDA authorized 421 tests and sample collection devices under EUAs.

These include 293 molecular tests and sample collection devices, 90 antibody and other immune response tests, and 38 antigen tests. In addition, there are 66 molecular authorizations and one antibody authorization that can be used with home-collected samples.

Also, there is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, nine EUAs for antigen over-the-counter (OTC) at-home tests, and three EUAs for molecular OTC at-home tests.

The FDA has also authorized 672 revisions to test EUA authorizations.