FDA Grants EUA for a Combined COVID-19 and Flu Home Testing Kit

The FDA has issued an emergency use authorization for a combined home collection kit that can simultaneously detect COVID-19 and influenza A/B in individuals aged 2 years and older.

The kit is made by Labcorp and will be available at a no-upfront cost for individuals who meet clinical guidelines, including symptoms, exposure to COVID-19, or getting tested by a health care provider.

“Our newest home collection kit makes it convenient for individuals, including children over the age of 2, to take the test in the safety of their homes,” Brian Caveney, MD, chief medical officer, and president of Labcorp Diagnostics, said in a statement. “In time for flu season, the single test helps doctors and individuals make more informed treatment decisions given that symptoms of COVID-19 and flu are similar.”

Because COVID-19 and the flu have similar symptoms, the kit helps individuals get tested for both viruses at home, without the risk of spreading either.

The kit comprises a short nasal swab that is inserted into the lower nostril, so it is easy to collect samples at home. Results average 1 to 2 days after Labcorp receives the collection kit.

Individuals aged 18 years or older or parents of children aged 2 through 17 years, can request a kit through Pixel by Labcorp, or a physician can order the collection kit via an electronic medical record system.

The home kit is shipped priority overnight and includes a prepaid resent envelope. Results can be accessed through the Pixel by Labcorp account or from the physician who ordered the test.

Reference

Labcorp receives emergency use authorization for at home collection kit for combined COVID-19 and flu detection. Business Wire. News release. October 1, 2021. Accessed on October 4, 2021. https://www.businesswire.com/news/home/20211001005498/en