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FDA Authorizes Non-Prescription At-Home Test for COVID-19, Flu, and RSV

The test will be available direct to consumers without a prescription.

The FDA has authorized the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test for use by consumers without a prescription. The test can be used by individuals who have respiratory viral infection symptoms consistent with those outlined for COVID-19. The test is the first non-prescription multianalyte COVID-19 test that has been authorized by the federal authority.

The home sample collection will be available either for purchase in a store or online. Samples can be self-collected by those aged 18 years and older; with adult supervision for those aged 14 to 17 years; or collected by an adult in children aged 2 to 13 years. Individuals can use the test to self-collect a nasal swab sample in their home and then send the specimen to Labcorp for testing. The test is able to identify not only COVID-19, but also influenza A and B as well as respiratory syncytial virus (RSV). Test results are provided by an online portal, and results that are either positive or invalid will trigger a follow-up with a health care provider.

In the release announcing the authorization, Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health said, “This is the first test authorized for flu and RSV, along with COVID-19, where an individual can self-identify their need for a test, order it, collect their sample and send it to the lab for testing, without consulting a health care professional. The rapid advances being made in consumer access to diagnostic tests, including the ability to collect your sample at home for flu and RSV without a prescription, brings us one step closer to tests for these viruses that could be performed entirely at home.”

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Reference

Coronavirus (COVID-19) update: FDA authorizes first COVID-19 test available without a prescription that also detects flu and RSV. News release. FDA. Published May 16, 2022. Accessed May 19, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-test-available-without-prescription-also


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