May 17, 2022 – OraSure Technologies announced that its InteliSwab® COVID-19 rapid tests detect the Omicron BA.2, BA.2.12.1, BA.3 and BA.5 subvariants with similar levels of detection to the original SARS-CoV-2 strain and other previous variants of concern, including Delta, Alpha, Beta, Gamma and Omicron BA.1. The Omicron sublineage studies were conducted using live SARS-CoV-2 virus at an independent, third-party laboratory and showed InteliSwab® detected the Omicron variants at similar viral load levels, or limit of detection, as previous variants that were tested.
Testing with InteliSwab® is simple: users swab their lower nostrils with the test stick, swirl it in a pre-measured solution, and see their result on the test stick in 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.”
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.
This product has not been FDA cleared or approved, but it has been authorized by the FDA under an EUA. The emergency use of this product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.