Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 and Flu Combination Test for use with home-collected samples - FDA.gov

Food and Drug Administration 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 health care 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.

“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.