India Pharma Outlook Team | Monday, 27 February 2023
The US Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test capable of distinguishing and detecting influenza A and B, also known as the flu, and SARS-CoV-2, the virus that produces Covid-19. The Lucira Covid-19 & Flu Home Test is a single-use at-home test kit that gives results in about 30 minutes from self-collected nasal swab samples. "Today's approval of the first OTC test capable of detecting Influenza A and B, as well as SARS-CoV-2, is a significant step towards increasing 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.
"The FDA firmly supports innovation in test development, and we are eager to continue promoting greater access to at-home infectious disease testing to best support public health needs. We remain dedicated to collaborating with test developers to achieve our common goal of providing more accurate and reliable tests to Americans in need." The Lucira Covid-19 & Flu Home Test is a one-time use test for people who have indications and symptoms of a respiratory tract infection, including Covid-19. The test is available without a prescription and can be completed entirely at home using nasal swab samples collected by people 14 years of age or older or collected by an adult for individuals 2 years of age or older.
The test works by swirling the sample swab in a vial that is placed in the test unit. In 30 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. Individuals should report all results obtained to their healthcare provider for public health reporting and to receive appropriate medical care. 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. Since there are currently not enough cases of Influenza B circulating to include in a clinical study, validation confirmed that the test can identify the virus in contrived specimens, and the EUA 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. Individuals who test positive for either flu or Covid-19 should take appropriate precautions to avoid spreading the virus and should 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 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 and should seek follow up care with their healthcare provider.
The collective impact of Covid-19, flu and RSV underscore the importance of diagnostic tests for respiratory viruses, and the FDA recognizes the benefits that home testing can provide. The agency will 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 FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements.
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