FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Influenza and COVID-19 Viruses

For Immediate Release:

Right now, the U.S. Food items and Drug Administration issued an crisis use authorization (EUA) for the very first around-the-counter (OTC) at-house diagnostic test that can differentiate and detect influenza A and B, typically known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Residence Exam is a one-use at-property test package that offers final results from self-collected nasal swab samples in about 30 minutes. 

“Today’s authorization of the initial OTC exam that can detect Influenza A and B, along with SARS-CoV-2, is a key milestone in bringing bigger customer access to diagnostic assessments that can be performed totally at dwelling,” reported Jeff Shuren, M.D., J.D., director of the FDA’s Center for Equipment and Radiological Overall health. “The Fda strongly supports innovation in examination development, and we are keen to proceed advancing better obtain to at-home infectious ailment screening to best assist general public wellness requires. We keep on being dedicated to doing work with check developers to guidance the shared target of getting much more correct and trusted tests to Us citizens who need to have them.”

The Lucira COVID-19 & Flu Home Check is a solitary use take a look at for people with signs and signs or symptoms regular with a respiratory tract an infection, including COVID-19. The take a look at can be procured devoid of a prescription and executed entirely at-home utilizing nasal swab samples self-collected by individuals ages 14 a long time or more mature or collected by an grownup for individuals 2 a long time of age or more mature. 

The test will work by swirling the sample swab in a vial that is put in the examination unit. In 30 minutes or a lot less, the exam unit will screen the outcomes that display whether a person is good or adverse for every single of the pursuing: Influenza A, Influenza B and COVID-19. Individuals must report all effects acquired to their healthcare service provider for public health and fitness reporting and to receive appropriate health care care. 

In individuals with signs and symptoms, the Lucira COVID-19 & Flu Residence Take a look at properly identified 99.3{2c3a8711102f73ee058d83c6a8025dc7f37722aad075054eaafcf582b93871a0} of unfavorable and 90.1{2c3a8711102f73ee058d83c6a8025dc7f37722aad075054eaafcf582b93871a0} of positive Influenza A samples, 100{2c3a8711102f73ee058d83c6a8025dc7f37722aad075054eaafcf582b93871a0} of damaging and 88.3{2c3a8711102f73ee058d83c6a8025dc7f37722aad075054eaafcf582b93871a0} of constructive COVID-19 samples and 99.9{2c3a8711102f73ee058d83c6a8025dc7f37722aad075054eaafcf582b93871a0} of detrimental Influenza B samples. Considering the fact that there are at the moment not plenty of conditions of Influenza B circulating to include things like in a clinical analyze, validation confirmed that the check can determine the virus in contrived specimens, and the EUA requires Lucira to keep on to acquire samples to study the test’s skill to detect Influenza B in actual-planet settings.   

As with all swift diagnostic checks, there is a threat of fake favourable and phony unfavorable results. Folks who exam favourable for both flu or COVID-19 should acquire appropriate precautions to avoid spreading the virus and ought to search for observe-up care with their medical doctor or healthcare service provider as additional tests may perhaps be essential. Adverse effects for SARS-CoV-2 and influenza B ought to be confirmed, if required for individual management, with an authorized or cleared molecular check carried out in a CLIA-qualified laboratory that satisfies necessities to accomplish high or average complexity checks. Persons who examination adverse and keep on to knowledge signs and symptoms of fever, cough and/or shortness of breath may well continue to have a respiratory an infection and must request observe up care with their health care company.

The collective impact of COVID-19, flu and RSV underscore the value of diagnostic checks for respiratory viruses, and the Food and drug administration recognizes the advantages that home testing can provide. The company will keep on to use its authorities to boost the number of appropriately precise and uncomplicated to use at-household tests accessible to the general public, in particular checks that detect these remarkably contagious respiratory viruses.



The Fda, an agency within just the U.S. Department of Health and Human Providers, protects the general public wellbeing by assuring the protection, usefulness, and stability of human and veterinary medicines, vaccines and other biological solutions for human use, and professional medical gadgets. The company also is liable for the basic safety and security of our nation’s meals supply, cosmetics, nutritional nutritional supplements, items that give off electronic radiation, and for regulating tobacco items.