FDA Approves Home Test for COVID and Flu Amid Rising Respiratory Illnesses

With respiratory illnesses on the rise across the United States, including COVID-19 and flu, the recent announcement from the U.S. Food and Drug Administration (FDA) comes as a welcome relief to those concerned about their health. The FDA has authorized a home test designed to distinguish between COVID-19 and flu, allowing individuals to determine their health status without the need for a prescription.

In the final week of 2024, reports indicated high levels of illness in 40 states, indicative of prevalent respiratory viruses. To address the confusion surrounding flu and COVID-19 symptoms, the FDA has approved the Healgen Rapid Check COVID-19/Flu A&B Antigen Test.

The Healgen test screens for both Influenza A and B, as well as the COVID-19 virus, making it a comprehensive option for those experiencing symptoms. The test is suitable for anyone aged 14 and older to self-administer, and can also be used for younger children with adult supervision.

Unlike other tests that were only authorized under emergency use, this approval marks the first significant endorsement following standard FDA processes, potentially paving the way for a broader market for at-home testing options.

The FDA reported that the test demonstrated high accuracy, identifying 99% of negative COVID and 92% of positive COVID samples during testing. For flu samples, the test successfully detected 99.9% of negative Flu A and B samples. This accuracy offers reassurances for individuals seeking reliable results from the comfort of their home.

A spokesperson for Healgen mentioned that tests will be available over the counter by Thanksgiving 2024, priced approximately between $13 and $16 each, making it an accessible option for many Americans.

This new testing solution aims to empower individuals to take control of their health, especially during upcoming cold and flu seasons. As notable respiratory illnesses continue to circulate, residents are encouraged to monitor their symptoms and follow health guidelines diligently.