FDA approves 1st combination COVID-flu test: 4 things to know

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: 

1. The at-home test provides results for both COVID-19 and influenza A and B within approximately 15 minutes, using a nasal swab sample. 
   
   
2. 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. 
   
   
3. 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. 
   
   
4. A positive result suggests the presence of either virus, while a negative result may need further confirmation.