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FDA Issues EUA for Combined Influenza-COVID-19 Diagnostic


The EUA is the third for diagnostics designed for detection and differentiation of the viruses that cause COVID-19 and the flu.

Testing for COVID-19

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The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for a third diagnostic test that detects and differentiates the viruses that cause influenza and COVID-19.

According to an agency press release, the three combination tests use a single patient sample to test for multiple respiratory diseases, such as seasonal flu and COVID-19, which can exhibit similar symptoms but would require different responses. The important advantages to the test include avoiding the need for multiple samplings which can be uncomfortable for patients and expediting resutls that are more comprehensive.

The combination tests also reduce use of supplies (eg, swabs, PPE) and as well as the burden on the supply chain for testing reagents.

“With the authorization of these tests, the FDA is helping address concerns in anticipation of this upcoming flu season during the COVID-19 pandemic, which might be especially worrying for some Americans," said FDA commissioner Stephen M Hahn, MD, in the press release. “With just one swab or sample, combination tests can be used to get answers to Americans faster. This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”

The FDA is encouraging more companies to collaborate with the agency on developing combination tests that will help preserve critical testing resources during the first influenza season during the COVID-19 pandemic. Updates to the Molecular Diagnostic EUA templates add information on the tests which will facilitate the preparation, submission, and authorization of the EUAs, the release says.

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