FDA authorizes first COVID-19 and flu combo test for use with home-collected samples

Dec. 7, 2020

The U.S. Food and Drug Administration (FDA) authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu).

The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s healthcare provider.

Under a healthcare provider’s order, patients 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.

FDA has the release

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