From the FDA go-ahead to the first do-it-yourself test capable of distinguishing Covid from the flu

The Lucira Covid-19 & Flu Home Test is a single-use test for individuals with signs and symptoms compatible with a respiratory tract infection, including Covid. The test can be purchased without a prescription and performed completely at home using self-collected nasal swab samples from individuals 14 years of age and older or collected by an adult for individuals 2 years of age and older.

25 FEB – The US Food and Drug Administration has issued an Emergency Use Authorization (EUA) for the first over-the-counter (OTC) home diagnostic test that can differentiate and detect influenza A and B, commonly known as influenza , and Sars-CoV-2, the virus that causes Covid. The Lucira Covid-19 & Flu Home Test is a single-use kit that provides results from self-collected nasal swab samples in approximately 30 minutes.

“Today’s authorization of the first OTC test capable of detecting influenza A and B, along with SARS-CoV-2, represents an important milestone in ensuring consumers have greater access to diagnostic tests that can be performed entirely at home,” he said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health -. The FDA strongly supports innovation in test development, and we look forward to continuing to promote greater access to home-based infectious disease testing to better address public health needs. We remain committed to working with test developers to support the common goal of providing more accurate and reliable tests to the Americans who need them.”

The Lucira Covid-19 & Flu Home Test is a single-use test for individuals with signs and symptoms compatible with a respiratory tract infection, including Covid. The test can be purchased without a prescription and performed completely at home using self-collected nasal swab samples from individuals 14 years of age and older or collected by an adult for individuals 2 years of age and older.

The test works by swirling the sample swab in a vial which is inserted into the test unit. In 30 minutes or less, the test unit displays results indicating whether a person is positive or negative for each of the following: Influenza A, Influenza B, and Covid. Individuals should report all results obtained to their healthcare professional for public health reporting and to receive appropriate medical care.

In subjects 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 samples and 88.3 % of Covid positive and 99.9% of Influenza B negative samples. As there are currently not enough Influenza B cases circulating to be included in a clinical trial, validation confirmed that the test is able to identify the virus in artificial samples, and the EUA expects Lucira to 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 the flu or for Covid should take precautions to avoid spreading the virus and should see their doctor or healthcare professional for a follow-up, as further tests may be needed. Negative results for SARS-CoV-2 and influenza B should be confirmed, if necessary for patient management, with a licensed or licensed molecular test performed in a CLIA certified laboratory that meets the requirements for performing high or moderate complexity. Individuals who test negative and who continue to experience symptoms of fever, cough and/or shortness of breath may still be suffering from a respiratory infection and should contact their health care provider.

February 25, 2023
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