An at-home test for flu and COVID can be marketed directly to consumers, the U.S. Food and Drug Administration said Monday.

Healgen’s Rapid Check COVID-19/Flu A&B Antigen Test can be used without a prescription and is the first over-the-counter test capable of detecting COVID-19 and the flu to be marketed without an emergency use declaration.

What You Need To Know

  • Healgen’s Rapid Check COVID-19/Flu A&B Antigen Test can be marketed to consumers, the U.S. Food and Drug Administration said this week

  • It's the first over-the-counter test capable of detecting COVID-19 and the flu to be marketed wthout an emergency use declaration

  • The nasal swab test can be used by people who are at least 14 years old who can collect and test their own sample or by people at least two years old, if the sample is taken and tested by an adult

  • The FDA said the test correctly identified 99% of negative and 92% of positive COVID samples; it correctly identified 99.9% of negative flu samples

Intended for people who are experiencing flu-like symptoms, the test uses a nasal swab sample to detect the virus that causes COVID or the viruses that cause flu. It takes about 15 minutes to get a result.

“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,” FDA Center for Devices and Radiological Health Acting Director Michelle Tarver said in a statement.

She said the FDA’s approval “expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home.”

Other over-the-counter flu and COVID tests are available, but only through an emergency use authorization.

The Healgen test can be used by people who are at least 14 years old who can collect and test their own sample or by people at least two years old, if the sample is taken and tested by an adult. 

The FDA said the test correctly identified 99% of negative and 92% of positive COVID samples. It correctly identified 99.9% of negative flu samples.