FDA Approves At-Home COVID-19 & Flu Test: Your Tax Dollars At Work!

In a move that's got both hypochondriacs and preppers rejoicing, the Food and Drug Administration has given the thumbs up to a COVID-19 and flu test that you can use without a prescription. That's right, folks, no more waiting in line with the sniffles, you can now DIY your diagnosis!

The test, created by Healgen Scientific LLC (a fine bunch of folks down in Houston, Texas), uses a nasal swab to detect the proteins from SARS-CoV-2 and Influenza A and B. This comes hot on the heels of the U.S. Department of Health and Human Services announcing free COVID-19 tests for all, just in time for flu season.

Dr. Michelle Tarver, the acting director of the FDA’s Center for Devices and Radiological Health, said in a statement, "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." She added, "(Monday)’s authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home."

Who Can Use This Test?

Anyone 14 years or older can use it independently, and those as young as 2 years can use it with adult supervision. Dr. Archelle Georgiou, former chair of the Board of Directors at Children’s Hospital and Clinics of Minnesota, called it a win for reducing ER visits and strain on the medical system.

How Accurate Is It?

The test identified:

• 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.

When Will Results Be Ready?

Results will be ready in just 15 minutes. Perfect for those who can't wait to know if they're sick or just dramatic.

When Should You Take the Test?

Got respiratory symptoms? Take the test. Simple as that.

Availability

Healgen says the tests will be available to the public and healthcare providers by Thanksgiving. You can find them at:

• Amazon
• CVS
• Other retail outlets

Healthcare providers can buy them from their distributors.

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