OraSure’s Easy and Intuitive ‘Swab, Swirl and See’ COVID-19 Tests Granted FDA Emergency Use Authorization

OraSure Technologies, Inc. (Bethlehem, PA, USA) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its InteliSwab COVID-19 rapid antigen tests which detect active COVID-19 infection.

The FDA has authorized the InteliSwab COVID-19 Rapid Test for Over-the-Counter (OTC) use without a prescription. 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.

InteliSwab COVID-19 Rapid Test is an OTC home test for use without a prescription in individuals 15 years or older (with or without symptoms) when tested twice over two or three days with at least 24 and no more than 36 hours between tests. InteliSwab COVID-19 Rapid Test Pro is a professional test, which is packaged in bulk configurations, and is authorized for use at the point of care in healthcare settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation, for individuals 15 years or older who are suspected of COVID-19 by their healthcare provider within seven days of symptom onset or for individuals without symptoms when tested twice over two or three days with at least 24 hours and no more than 36 hours between tests. The InteliSwab COVID-19 Rapid Test Rx is a prescription home test which is authorized for prescription home use with self-collection (unobserved) of anterior nasal samples from individuals 18 years or older or adult collected samples from individuals age 15 years or older who are suspected of COVID-19 infection by their healthcare provider within the first seven days of symptom onset.

The unique design of InteliSwab incorporates a built-in swab that is fully integrated into the test stick, simplifying the entire testing process. Use of this integrated swab also helps ensure supply continuity, as InteliSwab does not require sourcing scarce nasal swabs. 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. Using InteliSwab to test for COVID-19 requires less than one minute of “hands-on” time. In a clinical study at five independent US sites, InteliSwab had strong performance, with positive results agreeing with highly sensitive FDA-authorized PCR tests 84% of the time, and negative results agreeing 98% of the time. In addition, 98% of consumers in the clinical trial found InteliSwab easy-to-use.

“OraSure is on a mission to make COVID-19 testing dramatically simpler. We believe that this easy and intuitive ‘swab, swirl and see’ test will be one of the simplest COVID-19 tests on the market. We expect that InteliSwab’s™ simplicity and accuracy will give users peace of mind that they performed the test correctly and can rely on the results,” said OraSure President and CEO Stephen Tang, Ph.D. “Simple and accessible at-home tests, like InteliSwab, make it easier for individuals to know if they are infectious and to quickly self-isolate if they test positive. With InteliSwab, we believe OraSure will play an even larger role in safely reopening – and keeping open – workplaces, schools and other places where people congregate.”