Test will be sold without a prescription and can be used by anyone 14 years and older or by an adult on children ages 2 years and older<\/p>\n<\/h3>\n
By Physician\u2019s Briefing Staff HealthDay Reporter<\/b><\/p>\n
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MONDAY, Feb. 27, 2023 (HealthDay News) — 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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n