FDA authorizes Quest's home test kit for the flu and COVID-19

man with thermometer in his mouth
According to the Centers for Disease Control and Prevention, fewer people are currently making doctor’s office visits for influenza-like illnesses than the typical baseline—however, this type of surveillance is almost certainly affected by the COVID-19 pandemic. (Claus Rebler/CC BY-SA 2.0)

While the seasonal flu is seeing lower activity than usual for this time of year in the U.S., daily counts of cases and deaths from COVID-19 are at an all-time high—and the FDA is continuing to prepare for the dangerous intersection of these two infectious diseases.

On Dec. 4, the agency granted its first emergency authorization to an at-home test kit capable of detecting COVID-19 as well as influenza A and B. 

Offered by Quest Diagnostics, people with signs of respiratory infection can collect a nasal sample on their own and then mail the swab to the company’s laboratories to tell the difference between the viruses and seek appropriate care.

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“With just one swab or sample, combination tests that are authorized for use with home-collected samples 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 Hahn, M.D., said in an agency statement.

Available with a prescription, the self-collection process is intended for users over the age of 18, while adolescents and children can be swabbed with adult supervision. 

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“This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment,” Hahn said. The PCR test itself is carried out using Roche’s combination coronavirus and influenza test, authorized in September for its cobas 6800/8800 systems.

According to the Centers for Disease Control and Prevention (CDC), fewer people are currently making doctor’s office visits for influenza-like illnesses than the typical baseline—however, this type of surveillance is almost certainly affected by the COVID-19 pandemic. The CDC is also urging people to get their annual flu vaccine and is warning the public that influenza activity may increase in the coming months.