On Nov. 2, 2021, OraSure Technologies announced that the EUA for its InteliSwab™ COVID-19 rapid tests has been amended by the U.S. Food and Drug Administration (FDA) to only require one test for individuals with symptoms of COVID-19. Previously, the at-home test was authorized for over-the-counter use in people with or without symptoms when tested twice with at least 24 hours but not more than 36 hours between tests, which is called serial testing. Now, people with symptoms only need to test once; people without symptoms should still perform serial testing if they get a negative result on their first test.

In addition, OraSure conducted studies using live SARS-CoV-2 virus at independent laboratories which showed detection of all variants of concern, including the Delta variant. The FDA reviewed the data submitted by OraSure regarding the detection of the SARS-CoV-2 Delta variant and indicated that the data was adequate, and that no further data is required.

OraSure has received Emergency Use Authorizations (EUA) from the FDA for its InteliSwab™ COVID-19 rapid tests. The FDA has authorized the InteliSwab™ COVID-19 Rapid Test for Over-the-Counter (OTC) use without a prescription. The FDA has also authorized the InteliSwab™ COVID-19 Rapid Test Pro for professional use in point of care (POC) CLIA-waived settings, and the InteliSwab™ COVID-19 Rapid Test Rx for Prescription Home Use. These remarkably simple COVID-19 lateral flow tests use samples self-collected from the lower nostrils. InteliSwab™’s unique design incorporates a built-in swab fully integrated into the end of the test stick. After users swab their lower nostrils, the test stick is swirled in a pre-measured buffer solution, and the result appears right on the test stick within 30 minutes, with no instruments, batteries, smartphone, or laboratory analysis needed to see the result. With less than one minute of “hands-on time,” it is as simple as “Swab, Swirl, and See.”