FDA Authorizes First COVID-19 and Flu Combination Test for Use with Home-collected Samples

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US Food and Drug Administration

COVID-19 Update: FDA Issues First Emergency Use Authorization for a COVID-19 and Flu Combination Test for Use with Home-Collected Samples 

Today, the U.S. Food and Drug Administration (FDA) authorized the first diagnostic test for use with home- collected 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 health care provider’s order, patients can self-collect a nasal sample at home and then ship it to Quest Diagnostics for analysis, using the instructions in the collection kit. 

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