The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the first over-the-counter home diagnostic test to detect and differentiate influenza A and B, commonly known as influenza, and SARS-CoV-2, the virus that causes COVID-19.
The Lucira COVID-19 & Flu Test, endorsed on February 24, is a single-use test kit that provides results from self-collected nasal swab samples in about 30 minutes.
“The authorization of the first over-the-counter test that can detect influenza A and B, along with SARS-CoV-2, is a major achievement in providing greater consumer access to diagnostic tests that can be done completely at home,” said Dr. Jeff Shuren , director of the FDA’s Center for Devices and Radiological Health.
The Lucira COVID-19 & Flu Test is a single-use test for people with signs and symptoms associated with a respiratory tract infection, including COVID-19. In the US it can be purchased without a prescription and can be performed at home for people aged 14 years and older to use on their own or samples can be collected by an adult from children aged 2 years and older.
The test works by rotating the sample nasal swab in a vial that is placed in the test unit. In 30 minutes or less, the test unit will display results showing whether a person is positive or negative for each of the following: influenza A, influenza B, and COVID-19.
Individuals should report all results obtained to their health care provider for public health reporting and receive appropriate medical care .
As reported by the FDA, in people with symptoms, Lucira COVID-19 & Flu Test correctly identified 99.3% of negative samples and 90.1% of positive samples of influenza A, 100% of negative samples and 88. 3% of positive COVID-19 samples and 99.9% of negative influenza B samples.
Since there are currently not enough cases of influenza B in circulation to include them in a clinical study, validation confirmed that the test can identify the virus in artificial samples, and the EUA requires that Lucira continue collecting 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. People who test positive for influenza or COVID-19 should take appropriate precautions to prevent the spread of the virus and should seek follow-up care with their doctor 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 a licensed or approved molecular test performed in a compliant Clinical Laboratory Improvement Amendments-certified laboratory. to perform tests of high or moderate complexity. People who test negative and continue to experience symptoms of fever, cough, or shortness of breath may still have a respiratory infection and should seek follow-up care from their healthcare provider.
