First COVID-19 and Flu Combination Self Collection Test Authorized by FDA

The FDA has authorized a COVID-19 + Flu combination PCR test developed by Quest Diagnostics for at-home collection of respiratory samples.  This will only be available by prescription for patients with respiratory viral infection symptoms.

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Today’s authorization for a COVID-19 plus flu test using samples collected at home is a significant step toward FDA’s nationwide response to COVID-19. With the authorization of this test, the FDA is helping to address the ongoing fight against COVID-19 while in the middle of the flu season, which is important for many, including the most vulnerable of Americans. This is another example of the FDA working with test developers to bring important diagnostics to Americans,” said FDA Commissioner Stephen M. Hahn, M.D. “With just one swab or sample, combination tests that are authorized for use with home-collected samples can be used to get answers to Americans faster, in the comfort and relative safety of their home, which allows patients to continue to quarantine while awaiting results. This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-and-flu-combination-test-use-home?utm_medium=email&utm_source=govdelivery