FDA approves Lucira Flu home test for upper respiratory tract infection diagnosis

People experiencing upper respiratory symptoms may now determine if they have the flu or COVID-19 with a new at-home test. On Friday, Lucira COVID-19 and Flu Home Test received approval from the U.S. Food and Drug Administration (FDA) under an emergency use authorization (EUA).

A nasal swab can be used to take a sample from the nose and is then swirled in a vial of sample solution for those who have respiratory infection symptoms. The test device will reveal whether someone is COVID-19 or flu positive after 30 minutes. The test will be sold over the counter. Anybody over the age of 14 or an adult or a youngster over the age of two may use it.

According to the FDA, Lucira was accurate in 100% of negative samples and 100% of positive samples for COVID-19 and 99.3% of negative samples and 90.1% of positive samples for influenza A. It was 99.9% accurate for influenza B samples that were negative, but there wasn't enough virus in circulation to tell how accurate it was for samples that were positive. The study did support the ability of the test to detect influenza B in fabricated samples. The EUA mandates that Lucira keep gathering samples in order to research how well the test can identify influenza B in actual environments.

False positive and false negative outcomes are a possibility with any fast diagnostic tests. Those who test positive for either the flu or COVID-19 should take the proper precautions to prevent the virus from spreading and should follow up with their doctor or healthcare provider as further testing may be required. If it is required for patient treatment, negative findings for SARS-CoV-2 and influenza B should be verified using an approved or cleared molecular test carried out in a CLIA-certified laboratory that satisfies the standards for high or moderate complexity testing. Those who test negative but still have fever, a cough, or shortness of breath may still have a respiratory infection, so they should contact their doctor for follow-up care.

In conclusion, the combined effects of COVID-19, the flu, and RSV highlight the necessity of respiratory viral diagnostic tests, and the FDA is aware of the advantages that at-home testing may offer. The organization will continue to use its legal rights in order to make more relevant, user-friendly, at-home tests available to the general public, particularly those that identify these highly dangerous respiratory viruses.

Reference:

FDA authorizes first over-the-counter at-home test to detect both influenza and COVID-19 viruses. (n.d.). U.S. Food and Drug Administration; FDA. Retrieved March 6, 2023, https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-home-test-detect-both-influenza-and-covid-19-viruses