The Food and Drug Administration (FDA) has approved the first over-the-counter home test to detect and differentiate between influenza (commonly known as the flu) and COVID-19.
The test, conducted by Lucira Health of California, works similarly to standard at-home COVID tests, in which users swirl a self-collected nasal swab in a vial and place it in a testing unit. After waiting 30 minutes, the results show whether the person is positive or negative for influenza A, influenza B, or COVID-19.
“Today’s approval of the first OTC test capable of detecting influenza A and B along with SARS-CoV-2 is an important milestone in giving consumers greater 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 Friday.
The announcement follows a spike in cases of COVID-19, influenza and respiratory syncytial virus (RSV) towards the end of 2022, fueling fears of a “triple disease”.
In November, the Centers for Disease Control and Prevention (CDC) reported that 5.8% of outpatient visits were due to respiratory illnesses with symptoms such as fever, cough and sore throat — a 2.5% increase from baseline.
“The collective impact of COVID-19, influenza, and RSV underscores the importance of diagnostic testing 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 tell 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, more testing is needed for influenza B because there are not 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 contact a medical provider for additional testing even if the results are negative.
“The agency will continue to use its agencies to increase the number of reasonably accurate and easy-to-use home tests available to the public,” the FDA said, “particularly tests that detect these highly contagious respiratory viruses.”