First At-Home COVID-19 And Flu Test Kit Gets FDA Approval

The first combination COVID-19 and flu test designed for home-collected samples has been authorized by the FDA, meaning a single swab can be used to detect up to three different potential infections. The Quest Diagnostics test kit doesn't require users to go to their doctor, a hospital, or a test site in order to be tested, though the system doesn't give an instant result.

Instead, the Quest Diagnostics RC COVID-19 +Flu RT-PCR Test is designed to allow for a sample to be taken at home, and then that swab be sent off to a lab for processing. It arrives as flu season becomes an increasing concern for healthcare providers, given capacities in hospitals are already facing overwhelming numbers of patients during the coronavirus pandemic.

Indeed the coexisting of COVID-19 and influenza has long been a topic of worry for those responsible for healthcare services. In the 2018-2019 season, for example, the US CDC estimates that 35.5 million people were sick with flu, of which 16.5 million went to a healthcare provider because of it. It was responsible for over 490,000 hospitalizations, and more than 32,000 deaths.

The fear is that a widespread influenza season this year could create a perfect storm of sickness when combined with COVID-19. Healthcare officials have been recommending people get the flu vaccine for several months now, in an attempt to curtail infections and reduce the potential hit on already-overwhelmed hospitals.

This new US Food and Drug Administration emergency use authorization paves the way for more efficient testing. Using Quest Diagnostics' Self-Collection Kit for COVID-19 +Flu, it's a single nasal swab that is designed to be carried out at home and then packaged up to ship to the company's labs.

"With the authorization of this test," FDA Commissioner Stephen M. Hahn, M.D. said of the EUA, "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 of Americans."

While Quest Diagnostics does offer COVID-19 tests for sale directly, this new combination coronavirus and flu test isn't among them. Instead, it requires a prescription from a healthcare provider, who believes the patient shows signs of a respiratory viral infection consistent with COVID-19. The test results will cover both COVID-19 and influenza A and B.

Widespread access to testing has proved a controversial topic in the US amid the COVID-19 pandemic. Even today, many months after the first cases were identified, the ability to go and quickly get tested is far from ubiquitous. In its stead, the CDC has recommended that those who believe they may have been exposed to coronavirus self-isolate, though given the absence of symptoms in many cases that has proved a patchy solution.