FDA Approves First Over-the-Counter Combo Flu and COVID Test Outside of Emergency Use

The U.S. Food and Drug Administration (FDA) has authorized the first over-the-counter combination COVID-19 and influenza test, the Healgen Rapid Check COVID-19/Flu A&B Antigen Test, outside of emergency use. The test is for use by people 14 and older who can take their own sample, or those 2 and older who can have a sample taken by an adult, who are experiencing respiratory symptoms. It is available without a prescription.

Healgen’s test detects proteins from both SARS-CoV-2, which is the virus that causes COVID-19, and influenza A and B, which are the viruses that cause flu.

Data reviewed by FDA found the test correctly identified 99 percent of negative and 92 percent of positive COVID samples. Additionally, the test correctly identified 99.9 percent of negative flu samples, and 92.5 percent and 90.5 percent of positive flu samples, respectively. Like other over-the-counter COVID-19 antigen tests, FDA says a positive test result likely means a patient is positive while a negative rest result may require a confirmation test. However, people who test negative and continue to experience symptoms, including cough, fever and shortness of breath, should follow up with their healthcare provider. Similarly, FDA says those who test positive should take appropriate precautions to avoid spreading either virus and should also follow up with their healthcare provider.

“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 Michelle Tarver, MD, PhD, acting director of the FDA’s Center for Devices and Radiological Health. “Today’s authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home.”