- For Immediate Release:
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Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the primary over-the-counter (OTC) at-home diagnostic take a look at that may differentiate and detect influenza A and B, generally referred to as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test is a single-use at-home take a look at equipment that gives outcomes from self-collected nasal swab samples in roughly half-hour.
“Today’s authorization of the primary OTC take a look at that may detect Influenza A and B, together with SARS-CoV-2, is a significant milestone in bringing larger client entry to diagnostic exams that may be carried out solely at house,” mentioned Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA strongly helps innovation in take a look at improvement, and we’re keen to proceed advancing larger entry to at-home infectious illness testing to finest assist public well being wants. We stay dedicated to working with take a look at builders to assist the shared objective of getting extra correct and dependable exams to Americans who want them.”
The Lucira COVID-19 & Flu Home Test is a single use take a look at for people with indicators and signs according to a respiratory tract an infection, together with COVID-19. The take a look at could be bought with out a prescription and carried out utterly at-home utilizing nasal swab samples self-collected by people ages 14 years or older or collected by an grownup for people 2 years of age or older.
The take a look at works by swirling the pattern swab in a vial that’s positioned within the take a look at unit. In half-hour or much less, the take a look at unit will show the outcomes that present whether or not an individual is optimistic or destructive for every of the next: Influenza A, Influenza B and COVID-19. Individuals ought to report all outcomes obtained to their healthcare supplier for public well being reporting and to obtain acceptable medical care.
In people with signs, the Lucira COVID-19 & Flu Home Test accurately recognized 99.3% of destructive and 90% of optimistic Influenza A samples, 100% of destructive and 88.3% of optimistic COVID-19 samples and 99.9% of destructive Influenza B samples. Since there are presently not sufficient instances of Influenza B circulating to embody in a scientific research, validation confirmed that the take a look at can determine the virus in contrived specimens, and the EUA requires Lucira to proceed to accumulate samples to research the take a look at’s means to detect Influenza B in real-world settings.
As with all speedy diagnostic exams, there’s a danger of false optimistic and false destructive outcomes. Individuals who take a look at optimistic for both flu or COVID-19 ought to take acceptable precautions to keep away from spreading the virus and ought to search follow-up care with their doctor or healthcare supplier as extra testing could also be essential. Negative outcomes for SARS-CoV-2 and influenza B needs to be confirmed, if essential for affected person administration, with a licensed or cleared molecular take a look at carried out in a CLIA-certified laboratory that meets necessities to carry out excessive or reasonable complexity exams. Individuals who take a look at destructive and proceed to expertise signs of fever, cough and/or shortness of breath should have a respiratory an infection and ought to search observe up care with their healthcare supplier.
The collective impression of COVID-19, flu and RSV underscore the significance of diagnostic exams for respiratory viruses, and the FDA acknowledges the advantages that house testing can present. The company will proceed to use its authorities to improve the variety of appropriately correct and straightforward to use at-home exams accessible to the general public, particularly exams that detect these extremely contagious respiratory viruses.
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The FDA, an company inside the U.S. Department of Health and Human Services, protects the general public well being by assuring the security, effectiveness, and safety of human and veterinary medication, vaccines and different organic merchandise for human use, and medical units. The company is also chargeable for the security and safety of our nation’s meals provide, cosmetics, dietary dietary supplements, merchandise that give off digital radiation, and for regulating tobacco merchandise.
