First Approved Home Use Trio Rapid Test for COVID-19 and Flu

The first 'trio home rapid test' kit, approved in late 2024, allows for simultaneous testing of COVID-19, Influenza A, and Influenza B from a single nasal swab. It is expected to be available in pharmacies by the end of May. Previously, trio rapid tests and single flu rapid tests were for professional use only, requiring operation in medical facilities. The Ministry of Health and Welfare approved the home-use 'Novel Coronavirus and Influenza A, B Virus Antigen' trio rapid test kit in November 2024. The test requires only inserting the swab about 2 cm into the nostril, making it user-friendly. The FDA has established technical standards for influenza virus antigen rapid tests and novel coronavirus antigen tests, as well as guidelines for the registration of home-use in vitro diagnostic medical devices. During the review process, the FDA requires products to demonstrate sensitivity and specificity, and for home-use kits, manufacturers must verify that general users can correctly collect samples and interpret results using only the instructions, ensuring expected monitoring quality for home use. The FDA advises that rapid test kits are preliminary screening aids and individuals with worsening symptoms should seek prompt medical attention for diagnosis and timely treatment.