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FDA Authorizes First Combined Flu/COVID-19 Test

The US Food and Drug Administration (FDA) has authorized the first combined at-home test

Screen Shot 2023-04-01 at 9.09.36 AM

The US Food and Drug Administration (FDA) has authorized the first combined at-home test for flu and COVID-19. The over-the-counter test displays three separate positive/negative readings: influenza A, Influenza B and COVID-19. Similar to rapid antigen tests for COVID-19, samples are self-collected via nasal swabs. Results are available within 30 minutes. According to the FDA, the test is highly accurate. For COVID-19, the test correctly identified 100% of negative results (no false positives) and 88.3% of positive results. For Influenza A, it correctly identified 99.3% of negative samples and 90.1% of positive samples. For Influenza B, the test accurately identified 99.9% of negative samples. The test kit, manufactured by Lucira Health, is already sold in Europe and Canada. The version available in Europe also tests for RSV (respiratory syncytial virus). The single use test will require a prescription to purchase. The release date and price have not yet been announced, but some insurance plans could cover part of the cost.

Full Story: USA Today, Washington Post

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