Food and Drug Administration (FDA) authorised the first over-the-counter home test that detects and differentiates between 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, in which users twist a self-collected nasal swab into a vial and place it in a testing unit. After waiting 30 minutes, 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 an important milestone in bringing greater consumer access to diagnostic tests that can be done entirely at home.” Jeff Shuren, Director of the Department. The FDA’s Center for Devices and Radiological Health said in a statement Friday.
The announcement comes after a spike in cases of COVID-19, influenza and respiratory syncytial virus (RSV) in late 2022, fueling fears of “triplemia.”
In November, the Centers for Disease Control and Prevention (CDC) reported that 5.8% of outpatient visits were due to respiratory problems with symptoms of fever, cough and sore throat, an increase from baseline of 2.5%.
“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 influenza – have overlapping symptomsmaking them difficult for people determine what disease they have. But the FDA’s new test can tell the difference between the flu and COVID.
Second FDA, the test correctly identified 99.3% of negative influenza A samples and 90.1% of positive influenza A samples. It also identified 100% of negative samples and 88.3% of positive samples for COVID-19 and 99.9% of negative samples for influenza B. However, additional testing for influenza B will be required as there is no enough cases in the real world.
The agency still encourages people to take precautions if they test positive for the flu or COVID-19 and to follow up with a health care professional for further testing, even if the results are negative.
“The agency will continue to use its authority to increase the number of publicly accessible and easy-to-use at-home tests,” the FDA said, “especially tests that detect these highly contagious respiratory viruses.”
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