Test will be sold without a prescription and can be used by anyone 14 years and older or by an adult or children ages 2 years and older
A new at-home test will help people struggling with upper respiratory symptoms figure out whether they have COVID-19 or the flu. The U.S. Food and Drug Administration approved Lucira under an emergency use authorization (EUA) on Friday.
Those who have symptoms of a respiratory tract infection can collect a sample from their noses using a nasal swab and then swirling that in a vial of test solution. After 30 minutes, the test unit will show whether someone is positive for COVID-19 or flu. The test will be sold without a prescription. It can be used by anyone ages 14 years and older or by an adult on children ages 2 years and older.
The FDA notes that Lucira was accurate in 99.3 percent of negative samples and 90.1 percent of positive samples for influenza A and 100 percent of negative samples and 88.3 percent of positive samples for COVID-19. It was 99.9 percent accurate for negative influenza B samples, but there was not enough circulating virus to determine how accurate it was for positive samples.
The study did confirm that the test can identify influenza B in contrived specimens, according to the FDA. The EUA requires Lucira to continue collecting samples to study the test’s ability to detect influenza B in real-world settings.
People who have positive test results should share this information with their doctors, the FDA said. They should also take precautions to avoid spreading the virus and seek follow-up care with a physician. Negative results for severe acute respiratory syndrome coronavirus 2 and influenza B, if it is necessary for patient management, should be confirmed with an authorized molecular test performed in an approved laboratory, the FDA said.
The impacts of flu, COVID-19, and respiratory syncytial virus have underscored the importance of having tests for various respiratory viruses, the FDA said. The agency plans to continue increasing the number of easy-to-use, at-home tests available to the public.