FDA authorizes first combination COVID-19, flu test that uses home-collected samples

The FDA announced it authorized the first combination test that allows patients to collect saliva samples at home and have them analyzed at a laboratory for the presence of COVID-19, influenza A and influenza B.

The use of RC COVID-19 +Flu RT-PCR Test (Quest Diagnostics) in tandem with Self-Collection Kit for COVID-19 +Flu (Quest Diagnostics) is intended for those with a respiratory viral infection “consistent with COVID-19” and for whom home collection is “determined to be appropriate” by a health care provider, the agency said.

The combination tests “can be used to get answers to Americans faster, in the comfort and relative safety of their home, which allows patients to continue to quarantine while awaiting results,” FDA Commissioner Stephen M. Hahn, MD, said in a press release. “This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”

On its website, Quest Diagnostics indicated that it takes approximately 2 to 3 days for all patients and 2 days for “priority patients” (eg, hospitalized patients) to receive antibody and molecular diagnostic test results.