FDA Takes Action for Easier COVID-19 and Flu Testing at Home

The U.S. Food and Drug Administration (FDA) has officially authorized Healgen Scientific’s Rapid Check COVID-19/Flu A&B Antigen Test for over-the-counter (OTC) home use. This decision, announced on October 10, 2024, allows consumers to purchase and use the test without a prescription.

A Significant Move for Home Healthcare

While previous at-home combination tests for COVID-19 and the flu were only available under emergency use authorization, Healgen’s test is the first to be marketed outside of emergency use, marking a significant milestone in accessible healthcare. This home-use test can detect both SARS-CoV-2, the virus that causes COVID-19, and the two most common flu strains, Influenza A and B, within just 15 minutes using a simple nasal swab.

Accuracy and Application

The test is designed for self-use by individuals aged 14 years and older or administered by an adult for younger children aged 2 and up. FDA analysis showed that the test correctly identified 99% of negative and 92% of positive COVID-19 cases, as well as 99.9% of negative flu samples and over 90% of positive flu cases. However, the FDA noted that rapid antigen tests, like this one, may produce false negatives and advised follow-up with a healthcare provider if symptoms persist.

FDA’s Statement

Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, emphasized the importance of such tests during the upcoming flu season, stating, “Our ability to detect these pathogens effectively and efficiently can be impactful on our daily lives.” This authorization provides individuals with more options to manage their health from home, reducing the strain on healthcare facilities and minimizing the spread of infections.