First Over-the-Counter Covid-19 Test Gets FDA Clearance

The U.S. Food and Drug Administration on Tuesday authorized a Covid-19 test that can be administered and processed at home, the first such test allowed to be sold over-the-counter at drugstores or other retail locations without a prescription.

The antigen test, made by Ellume USA LLC, is a single-use, disposable test that searches for pieces of virus proteins and returns results in about 15 minutes. It is the second to be authorized for at-home use.

Ellume’s test is expected to cost around $30 and requires a smartphone, the company says. The test is authorized to be used by people both with and without symptoms. It can also be used on children as young as 2 years old.

“Today’s authorization is a major milestone in diagnostic testing,” FDA Commissioner Stephen Hahn said. “By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes.”

Ellume, based in Australia, aims to ship 100,000 tests a day in January, said Sean Parsons, the company’s founder and chief executive officer. In October, the company received $30 million from the U.S. federal government through the Rapid Acceleration of Diagnostics initiative at the National Institutes of Health, and the U.S. is the company’s primary market.

To run the test, a person swabs themselves with a nasal swab and inserts their sample into the analyzer. The test’s results are then transmitted to the person’s phone via Bluetooth, where the person can choose to share the results with a health-care provider. The result can’t be accessed without downloading the app, the company says.

The mobile application requires users to input their Zip Codes and dates of birth. Names and email addresses are optional. The information is sent to public-health authorities.

Clinical studies of the test were conducted with 198 participants across five U.S. states. The test’s accuracy was compared with that of the gold standard, laboratory-based PCR test. Ellume’s test correctly identified 96% of positive samples and 100% of negative samples among people with symptoms. The test fared slightly worse among people without symptoms. It correctly flagged 91% of positive samples and 96% of negative samples.

For people without symptoms, a positive on the test should be treated as presumptive and confirmed by another test, the FDA said. People with Covid-19-like symptoms who receive a negative test result should follow up with their health-care provider, the agency said.