OraSure Technologies said it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the company’s COVID-19 rapid antigen tests.
The FDA has authorized the InteliSwab COVID-19 Rapid Test for over-the-counter (OTC) use without a prescription, FDA has also authorized the 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.
OraSure said it plans to market three products:
· InteliSwab COVID-19 Rapid Test, which 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: The Professional Test, which is packaged in bulk configurations, 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 7 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.
· InteliSwab COVID-19 Rapid Test Rx, which is a prescription home test for 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 (7) days of symptom onset.
