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. 

Advertisement

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. 

At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.

Register to Attend Webinar

The Performance Gap Your Pharmacy Training Metrics Can’t See

Monday, August 10
12:00 PM - 1:00 PM CDT

Presenters: Michael Alexander, AudirieDr. Tina Moen, PharmD, Colibri Healthcare

Advertisement

Next Up in Pharmacy

Advertisement

Comments are closed.