FDA OKs first COVID-19 and flu combo test
Under a health care provider’s request, patients can now collect a home sample for combination COVID-19 and influenza testing and send it to Quest Diagnostic laboratory for analysis.
On Friday, FDA authorized the first diagnostic test for at-home collection of patient samples to detect COVID-19 and influenza A and B. The test, Quest Diagnostic RC COVID-19 + Flu RT-PCR Test, was cleared for prescription use with the Quest Diagnostic Self-Collection Kit for COVID-19 + Flu, by people suspected of having respiratory viral infection consistent with COVID-19 and when home collection is determined to be appropriate by a patient’s health care provider.
“With the authorization of this test, the FDA is helping to address the ongoing fight against COVID-19 while in the middle of the flu season, which is important for many, including the most vulnerable American,” said FDA Commissioner Stephen M. Hahn, MD, in a statement. “With just one swab or sample, combination tests that are authorized for use with home-collection samples can be used to get answers to Americans fast, in the comfort and relative safety of their home, which allows patients to continue to quarantine while awaiting results.”