Over-the-counter coronavirus test gets FDA approval

WASHINGTON — The first home test for COVID-19 that doesn’t require a prescription will soon be on U.S. store shelves.

U.S. officials Tuesday authorized the rapid coronavirus test which can be done entirely at home. The announcement by the Food and Drug Administration represents another important — though incremental — step in U.S. efforts to expand testing options.

The agency’s action allows the test to be sold in places like drugstores “where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen Hahn, in a statement.

Regulators granted emergency use for a similar test last month, but that one requires a doctor’s prescription.

Initial supplies of the over-the-counter test will be limited. Australian manufacturer Ellume said it expects to produce 3 million tests next month before ramping up production over the first half of 2021.

A company spokesperson said the test will be priced around $30 and be available at pharmacies and online. The test connects to a digital app to help users interpret the results.

By MATTHEW PERRONE AP Health Writer

• • •

Tampa Bay Times coronavirus coverage

HOW CORONAVIRUS IS SPREADING IN FLORIDA: Find the latest numbers for your county, city or zip code.

VACCINES Q & A: Have coronavirus vaccine questions? We have answers, Florida.

FACE MASKS: Read the latest on guidelines, tips for comfort and long-term wear

GET THE DAYSTARTER MORNING UPDATE: Sign up to receive the most up-to-date information.

THE CORONAVIRUS SCRAPBOOK: We collected your stories, pictures, songs, recipes, journals and more to show what life has been like during the pandemic.

A TRIBUTE TO THE FLORIDIANS TAKEN BY THE CORONAVIRUS: They were parents and retirees, police officer and doctors, imperfect but loved deeply.

HAVE A TIP?: Send us confidential news tips

We’re working hard to bring you the latest news on the coronavirus in Florida. This effort takes a lot of resources to gather and update. If you haven’t already subscribed, please consider buying a print or digital subscription.