The FDA authorized the Healgen Rapid Check COVID-19/Flu A&B Antigen Test for over-the-counter use, the first combination test to receive approval outside of an emergency context, ABC News reported Oct. 8.
Here are four things to know:
- The at-home test provides results for both COVID-19 and influenza A and B within approximately 15 minutes, using a nasal swab sample.
- The test is designed for people 14 and older who can self-administer it, while children 2 and older are able to use the test with assistance from an adult.
- The FDA reported that the test accurately identified 99% of negative COVID-19 samples and 92% of positive samples. For the flu, the test showed 99.9% accuracy for negative samples and 92.5% and 90.5% accuracy for positive samples of influenza A and influenza B, respectively.
- A positive result suggests the presence of either virus, while a negative result may need further confirmation.