FDA Authorizes First Home Combo Flu & COVID-19 Test
By Sam Brusco, Associate Editor | 02.27.23
Lucira's test can distinguish between influenza A and B, as well as SARS-CoV-2 in about 30 minutes.
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the first over-the-counter (OTC), at-home diagnostic test that can distinguish between influenza A and B, as well as SARS-CoV-2.
The Lucira COVID-19 & flu home-test is a single-use, home test kit that generates results from self-collected nasal swab samples in about half an hour.
“[This] 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, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, told the press. “The FDA strongly supports innovation in test development, and we are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs. We remain committed to working with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them.”
The test can be bought without a prescription and administered completely at home via nasal swab samples self-collected by people 14 years or older, or collected by an adult for those two and older.
The user simply swirls the sample swab in a vial that is then placed in the test unit. In about 30 minutes, the test unit will display results showing whether the individual if positive or negative for influenza A, influenza B, and COVID-19.
Lucira’s test correctly identified 99.3% of negative and 90.1% of positive Influenza A samples, 100% of negative and 88.3% of positive COVID-19 samples and 99.9% of negative Influenza B samples.
As with all rapid diagnostic tests, there’s a potential risk of false positive and false negative results. Test results should be confirmed if necessary through molecular testing performed in a CLIA-certified lab.
The Lucira COVID-19 & flu home-test is a single-use, home test kit that generates results from self-collected nasal swab samples in about half an hour.
“[This] 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, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, told the press. “The FDA strongly supports innovation in test development, and we are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs. We remain committed to working with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them.”
The test can be bought without a prescription and administered completely at home via nasal swab samples self-collected by people 14 years or older, or collected by an adult for those two and older.
The user simply swirls the sample swab in a vial that is then placed in the test unit. In about 30 minutes, the test unit will display results showing whether the individual if positive or negative for influenza A, influenza B, and COVID-19.
Lucira’s test correctly identified 99.3% of negative and 90.1% of positive Influenza A samples, 100% of negative and 88.3% of positive COVID-19 samples and 99.9% of negative Influenza B samples.
As with all rapid diagnostic tests, there’s a potential risk of false positive and false negative results. Test results should be confirmed if necessary through molecular testing performed in a CLIA-certified lab.
