FDA Authorizes New At-home Rapid Test for COVID-19

The U.S. Food and Drug Administration (FDA) has approved a new over-the-counter COVID-19 antigen test—the Flowflex COVID-19 Home Test from ACON Laboratories—to increase consumer access to testing during the pandemic. The Flowflex test comes with swabs, a chemical solution, and a testing strip, and it provides results in as little as 15 minutes.

Since March 2020, the FDA has authorized more than 400 COVID-19 tests and sample collection devices. However, this authorization is significant as it should boost the availability of rapid at-home tests and double at-home testing capacity in the United States. ACON Laboratories plans to produce 100 million at-home tests monthly and double that to 200 million each month by February 2022. ACON Laboratories has not yet stated how much the tests cost.

What’s an Antigen Test?

A COVID-19 antigen test detects specific proteins in the virus. At-home antigen tests allow people to collect their nasal fluid or saliva sample and receive results typically in less than 30 minutes. Most at-home antigen tests are also authorized for serial testing, which tests the same individual more than once within a few days.

Due to antigen tests’ sensitivity, health experts recommend them to people who have symptoms since there is likely a more significant amount of the virus in their bodies. Availability and pricing vary, so check your major local retailer for at-home COVID-19 tests.

To learn more about self-testing and reporting results, visit the Centers for Disease Control Prevention’s website.

What’s Next?

At-home diagnostic tests can play a critical role in the fight against COVID-19 in the United States. The market for home test kits will likely grow, so stay tuned for more details.