FDA authorizes first at-home COVID-19 and flu combination test

US & World

CHICAGO (NewsNation Now) — The Food and Drug Administration approved the first at-home diagnostic test for both COVID-19 and the flu Friday.

The agency authorized the test kit by Quest Diagnostics. A health care provider must prescribe the test for patients. Patients then can collect a sample at home and ship it to a Quest Diagnostics laboratory for analysis following the instructions included with the self-collection kit.

The FDA says the at-home test allows patients to safely test from the comfort of their own home while they continue quarantining as they await results.

“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. 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.”

FDA Commissioner Stephen M. Hahn, M.D.

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