The US Food and Drug Administration has authorized a new at-home COVID and flu test called the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. This test screens for Influenza A and B viruses, which cause flu each season, as well as the virus that causes COVID-19. It is designed for individuals aged 14 and up who are able to take their own sample, or children as young as age 2 if an adult can take the sample for them. Unlike other combined COVID and flu tests authorized under emergency use authorization, this De Novo authorization is the first to receive FDA approval outside of pandemic-era marketing rules. This sets a precedent for future at-home tests to be cleared by the agency more easily, providing consumers with more choice and access to at-home testing options.
The FDA has stated that the Healgen test correctly identified 99% of negative and 92% of positive COVID samples, as well as 99.9% of negative Flu A and B samples and over 90% of positive flu samples. However, there is a risk of false negative results with rapid antigen tests, meaning that a negative result does not definitively rule out the presence of either the flu or COVID. It is important for individuals experiencing symptoms to follow updated guidance on what to do when displaying symptoms of a cold, flu, or COVID. Seeking medical care or consulting a doctor is especially crucial for those at higher risk of severe illness from these viruses, as timely treatment can help lessen the severity of symptoms.
According to a spokesperson for Healgen, the at-home tests are expected to be available over the counter by Thanksgiving at a list price of around $13 to $16 per test. They will be sold through retailers such as CVS and Amazon. This development expands testing options for individuals with respiratory symptoms, allowing them to receive crucial health information from the comfort of their homes. By supporting the development and availability of at-home tests for various medical conditions, the FDA aims to provide consumers with convenient and reliable testing solutions, ultimately enhancing public health and disease prevention efforts.
As the availability of at-home testing options increases, individuals should remain vigilant about following recommended protocols for managing symptoms and seeking medical care when necessary. The FDA continues to prioritize the development and approval of innovative testing solutions to empower individuals to proactively monitor their health and seek appropriate care when needed. By expanding access to at-home testing for COVID and flu, the FDA aims to enhance public health response efforts and improve outcomes for individuals by facilitating timely identification and management of respiratory illnesses.
