FDA Authorizes First At-Home Test That Can Detect Flu And COVID-19
The Food and Drug Administration (FDA) authorized the first over-the-counter at-home test to detect and differentiate influenza (commonly known as the flu) and COVID-19.
The test, made by California-based Lucira Health, works similarly to standard at-home COVID tests where users swirl a self-collected nasal swab in a vial and place it in a test unit. After a 30-minute wait, the results will show whether the individual is positive or negative for influenza A, influenza B or COVID-19.
“Today’s authorization of the first OTC test that can detect influenza A and B, along with SARS-CoV-2, is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement on Friday.
The announcement follows a surge in cases of COVID-19, flu and respiratory syncytial virus (RSV) towards the end of 2022, igniting fears of a ”tripledemic.”
In November, the Centers for Disease Control and Prevention (CDC) reported that 5.8% of outpatient visits were due to respiratory illnesses with symptoms of fever, cough and sore throat ― an increase from the baseline of 2.5%.
“The collective impact of COVID-19, flu and RSV underscore the importance of diagnostic tests for respiratory viruses, and the FDA recognizes the benefits that home testing can provide,” the FDA said in a statement.
The three respiratory viruses — RSV, COVID-19, and the flu — share overlapping symptoms, making it difficult for people to determine which illness they have. But the new FDA test can differentiate between the flu and COVID.
According to the FDA, the test correctly identified 99.3% of negative and 90.1% of positive influenza A samples. It also identified 100% of negative and 88.3% of positive COVID-19 samples and 99.9% of negative influenza B samples. However, further testing will be required for influenza B since there aren’t enough cases in real-world settings.
The agency still encourages people to take precautions if they test positive for the flu or COVID-19 and to follow up with a medical provider for additional testing even if results are negative.
“The agency will continue to use its authorities to increase the number of appropriately accurate and easy-to-use at-home tests available to the public,” the FDA stated, “especially tests that detect these highly contagious respiratory viruses.”
