FDA Authorizes Prescription-Free COVID-19 and Flu Home Test

The Food and Drug Administration has authorized a COVID-19 and flu test that can be used without a prescription. The authorization, announced Monday, uses a nasal swab to detect proteins from SARS-CoV-2 and Influenza A and B.

The test was developed by Healgen Scientific LLC, a Houston-based medical equipment manufacturer. This news follows the U.S. Department of Health and Human Services announcement that households nationwide can obtain four free COVID-19 tests, with flu season expected to start in October.

“As we enter this year’s annual flu season with respiratory illnesses such as COVID-19 on many of our minds, our ability to detect these pathogens effectively and efficiently can be impactful on our daily lives,” said Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, in a statement.

“[Monday]’s authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home,” Tarver added.

Key Details About the COVID-19 and Flu At-Home Test

Free COVID-19 Tests

Free COVID-19 tests are now available. Learn how to get them.

Usage

The nasal swab test can be used independently by anyone 14 years or older, and with adult supervision for those 2 years and older, the FDA said.

“Getting accurate, timely diagnostic information in the safety, comfort and convenience of your own home can provide substantial benefits—including facilitating the speed for possible physician diagnosis and treatment," said Dr. Archelle Georgiou, past chair of the Board of Directors at Children’s Hospital and Clinics of Minnesota, in a statement to USA TODAY.

Study Results

• COVID-19 (SARS-CoV-2 virus): 99% of negative and 92% of positive samples.
• Flu (Influenza A and B): 99.9% of negative; 92.5% and 90.5% of positive Flu A and Flu B samples, respectively.

Result Time

Results are expected within 15 minutes after the test is administered.

When to Test

The FDA suggests testing for anyone experiencing respiratory symptoms.

Availability

Tests will be available to the public and healthcare providers soon, aiming for U.S. availability by Thanksgiving.

Purchase Locations

• Amazon
• CVS
• Other retail outlets

Healthcare providers can purchase tests from their distributors.

Manufacturer Statement

“This De Novo authorization represents a significant milestone for Healgen," said Bryan Fang, Healgen's president. "With our existing state-of-art manufacturing facility, we plan to scale up production to meet global demand for the upcoming fall respiratory season.”

Ahjané Forbes is a reporter on the National Trending Team at USA TODAY. Email her at aforbes@gannett.com. Follow her on Instagram, Threads, and X (Twitter) @forbesfineest.