FDA authorizes 1st over-the-counter combo flu and COVID test outside of emergency use
The U.S. Food and Drug Administration authorized the first over-the-counter combination COVID-19 and flu test outside of emergency use on Monday evening.
This means the Healgen Rapid Check COVID-19/Flu A&B Antigen Test is available without a prescription. The FDA said the test is for those who are experiencing respiratory symptoms.
While there are other over-the-counter combination tests currently available, this is the first to be marketed to consumers using the traditional approval pathway outside of a public health emergency.
The new combination test uses a nasal swab sample to deliver at-home results for COVID-19 and influenza in approximately 15 minutes.
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.
"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. "Today's authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home."
"The FDA continues to take actions that support the development and availability of at-home tests for a variety of medical conditions," the statement continued.
The test is for use by people 14 and older who can take their own sample, or those 2 and older, who have a sample taken by an adult, according to the federal health agency.
Data reviewed by the FDA found the test correctly identified 99% of negative and 92% of positive COVID samples. Additionally, the test correctly identified 99.9% of negative flu samples, and 92.5% and 90.5% of positive flu samples, respectively.
Like other over-the-counter COVID-19 antigen tests, the 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 health care provider, the FDA says. Similarity, the FDA says those who test positive should take appropriate precautions to avoid spreading either virus and should also follow up with their health care provider.
