The U.S. Food and Drug Administration (FDA) recently authorized the first over-the-counter (OTC) at-home diagnostic test to differentiate between flu viruses.
And this innovative test can detect the SARS-CoV-2 coronavirus that causes COVID-19, and results are produced in about thirty minutes.
Furthermore, the test can be purchased without a prescription ($99) and performed completely at-home.
“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,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, in a press release on February 24, 2023.
“The FDA strongly supports innovation in test development, and we are eager to continue advancing greater access to at-home infectious disease testing to support public health needs best.”
“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 Lucira COVID-19 & Flu Home Test is a single-use test for individuals with signs and symptoms consistent with a respiratory tract infection, including COVID-19.
Lucira conducts routine surveillance of emerging SARS-CoV-2 strains and will continue to monitor the situation with emerging variants. For the latest variant information, please visit https://www.lucirahealth.com/technical-brief.
The test works by swirling the sample swab in a vial placed in the test unit.
In thirty minutes or less, the test unit will display the results that show whether a person is positive or negative for each of the following: Influenza A, Influenza B, and COVID-19.
In individuals with symptoms, the Lucira COVID-19 & Flu Home 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.
The FDA’s authorization requires Lucira to continue to collect samples to study the test’s ability to detect Influenza B in real-world settings.
As with all rapid diagnostic tests, there is a risk of false positive and false negative results. Therefore, individuals who test positive for either flu or COVID-19 should take appropriate precautions to avoid spreading the virus and seek follow-up care with their physician or healthcare provider, as additional testing may be necessary.
Negative results for SARS-CoV-2 and influenza B should be confirmed, if necessary for patient management, with an authorized or cleared molecular test performed in a CLIA-certified laboratory that meets the requirements to perform high or moderate complexity tests.
Individuals who test negative and continue to experience symptoms of fever, cough, and/or shortness of breath may still have a respiratory infection. Therefore, they should seek care from their healthcare provider.
The FDA stated it would continue to use its authorities to increase the number of appropriately accurate and easy-to-use at-home tests available to the public, especially tests that detect these highly contagious respiratory viruses.
The U.S. Centers for Disease Control and Prevention (CDC) says several tests are available to detect flu viruses in respiratory specimens. The most common is called rapid influenza diagnostic tests.
Other flu tests called rapid molecular assays detect the genetic material of the flu virus. These tests produce results in 15-20 minutes and are generally accurate.
The FDA is an agency within the U.S. Department of Health and Human Services.