WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration has granted marketing authorization for the first Flu and Covid-19 combination test that can be conducted at home, outside of Emergency Use Authorities.
The Healgen Rapid Check Covid-19/Flu A&B Antigen test, authorized for sale without a prescription, is for use by individuals experiencing respiratory symptoms. By using a nasal swab sample at-home, the suspect can get test results in approximately 15 minutes for Covid and influenza.
The test detects proteins from both SARS-CoV-2 - the virus that causes COVID-19 - and influenza A and B - the viruses that cause flu.
This is the first over-the-counter test that can detect influenza to be granted marketing authorization using a traditional pre-market review pathway, which enables the test to be marketed in the absence of an applicable emergency use declaration.
Other OTC flu/Covid tests are currently available under emergency use authorization.
The test is for use by individuals 14 years or older taking and testing their own sample, or individuals 2 years and older with a sample taken and tested by an adult.
FDA said it granted marketing authorization after reviewing data from a study of individuals with signs and symptoms of Covid-19 and influenza. The study showed that this test correctly identified 99 percent of negative and 92 percent of positive SARS-CoV-2 samples, 99.9 percent of negative Flu A and B samples, and 92.5 percent and 90.5 percent of positive Flu A and Flu B samples, respectively.
FDA cautioned that as with all rapid antigen tests, which generally have lower sensitivity than molecular tests, there is a risk of false negative test results.
Individuals who test negative and continue to experience symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2, flu or another respiratory infection and should seek follow up care with their health care provider, the federal agency said in a press release.
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