FDA greenlights combination at-home test for COVID and influenza in children as flu season approaches

With the school year now solidly underway and more people making their return to the workplace, the U.S. is once again facing a familiar wrinkle to dealing with the COVID-19 pandemic: the return of flu season.

Labcorp aims to tackle both infections with a single test following a new emergency authorization from the FDA for an at-home collection kit to gather samples from children as young as two years old.

The company said the combination test under its Pixel brand will be available at no upfront cost to people meeting certain clinical guidelines for screening, such as those who have been exposed to COVID-19 or currently have symptoms as well as those who have been directed to get a test by their healthcare provider.

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“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,” Labcorp’s chief medical officer and diagnostics president, Brian Caveney, M.D., said in a statement.

This can include fevers, runny noses and coughs. The test itself relies on a Roche cobas diagnostic for the coronavirus plus influenza A and B, while Labcorp’s at-home kit includes a short nasal swab designed for sweeping the lower nostril and a prepaid FedEx envelope for shipping the sample back to the lab. 

Labcorp estimates a turnaround time of 24 to 48 hours for results after the swab is delivered. To date, the company said it has performed more than 50 million PCR tests since the pandemic began spreading across the U.S. in March 2020 and that it can currently process up to 300,000 tests per day.

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Labcorp’s at-home collection kits started hitting virtual and in-store shelves this past April, following the FDA’s initial emergency green lights allowing it to be self-performed and without a prescription.