The Omicron sub-lineage studies, carried out at an independent third-party laboratory, have shown that the test identified the Omicron variants at similar viral load levels as previous variants.
OraSure Diagnostics president Lisa Nibauer said: “The Covid-19 pandemic remains highly dynamic with new variants of the disease emerging frequently. OraSure is committed to ensuring our science remains robust as we continue to see rapid evolution of the virus over time.
“InteliSwab has performed remarkably well against all new variants of the Covid-19 virus to date, and we will continue to work to ensure that consumers can rely on the accuracy of our test.”
The InteliSwab Covid-19 rapid test is designed to offer results in 30 minutes.
The kit includes a test stick to collect a swab from the lower nostrils. Subsequently, the individual can swirl the test stick in a pre-measured solution to get results.
The test has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA ). It has also received authorisation for Over-the-Counter (OTC) use without a prescription.
Additionally, the FDA has approved the use of InteliSwab Covid-19 Rapid Test Pro for professional use in point of care (POC) clinical laboratory improvement amendments (CLIA)-waived settings as well as the InteliSwab Covid-19 Rapid Test Rx for Prescription Home Use.
Earlier this year, InteliSwab Covid-19 Rapid Tests were approved by the FDA for use in children aged two to 14 years.