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Medical News in Brief
March 8, 2023

FDA Approves First Over-the-counter Combined COVID-19 and Flu Test

JAMA. 2023;329(12):968. doi:10.1001/jama.2023.3192

In late February, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization to an at-home diagnostic test that identifies SARS-CoV-2, the virus that causes COVID-19, as well as influenza strains A and B. The test detected 100% of negative and 88.3% of positive COVID-19 samples, 99.3% of negative and 90% of positive influenza A samples, and 99.9% of negative influenza B samples.

iStock.com/Courtney Hale

The single-use test, developed by the company Lucira, uses nasal swabs self-collected by people aged 14 years or older, or collected by an adult for those aged 2 years or older. Patients should report their results to their physician to obtain follow-up care, if needed, and for public health reporting, the FDA said.

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Article Information

Published Online: March 8, 2023. doi:10.1001/jama.2023.3192

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