COVID or flu? FDA approves first at-home test for both
MONDAY, Feb. 27, 2023 (HealthDay News) — A new at-home test will help people suffering from upper respiratory symptoms know if they have COVID-19 or the flu.
The US Food and Drug Administration (FDA) approved Lucira on Friday under an emergency use authorization (EUA).
“Today’s authorization of the first non-prescription test that can detect influenza A and influenza B, along with SARS-CoV-2, is an important milestone in providing greater consumer access to diagnostic tests that can be performed completely at home,” he said in an FDA news release on Dr. Jeff Shuren, director of the agency’s Center for Devices and Radiological Health. “FDA strongly supports innovation in test development, and we look forward to continuing to advance greater access to home infectious disease testing to better support public health needs.”
Those who have symptoms of a respiratory tract infection can collect a sample from their nose with a nasal swab, and then mix it in a vial of test solution. After 30 minutes, the test shows if someone has a positive COVID or flu result.
The test will be sold without a prescription. Anyone 14 years and older can use it, or an adult can give it to a child 2 years and older.
The FDA notes that Lucira was 99.3 percent accurate on negative samples and 90.1 percent accurate on influenza A positive samples, and 100 percent accurate on negative samples and 88.3 percent accurate on influenza A positive samples. covid. It was 99.9 percent accurate on negative influenza B samples, but there was not enough virus in circulation to determine its accuracy on positive samples.
The study did confirm that the test can identify influence B in pooled specimens, according to the FDA. The EUA requires that Lucira continue to collect samples to study the ability of the test to detect influenza B in the real world.
People who test positive should share this information with their doctor, the FDA said. They should also take precautionary measures to prevent the spread of the virus, and see a doctor for follow-up care.
Negative results for SARS-CoV-2 and influenza B, if necessary for patient management, must be confirmed by an authorized molecular test performed at an approved laboratory, the FDA emphasized.
People who have a fever, cough or shortness of breath even after a negative test may still have a respiratory infection, the FDA noted. They should see their health care provider for follow-up care.
The impact of the flu, COVID and RSV have underscored the importance of testing for various respiratory viruses, the FDA said. The agency plans to continue to increase the number of easy-to-use at-home tests available to the public.
Lucira Health, the company that makes the test, has filed for bankruptcy, so it’s unclear what its manufacturing capacity will be at this point, or what the possible prices of the tests would be, the report reported. New York Times.
The company was “very excited” about the clearance, Erik Engelson, Lucira’s chief executive officer, said in a statement Friday. Times.
“I can’t thank our employees and partners enough for sticking with it all the way, and of course, for the FDA recognition,” Engelson said.
Lucira had said she was anticipating the EUA in August, before the start of the flu season, but the FDA process “got long,” the report reported. Times.
More information
The US Centers for Disease Control and Prevention (CDC) has more about COVID-19 tests.
Article by HealthDay, translated by HolaDoctor.com
FUENTE: U.S. Food and Drug Administration, news release, Feb. 24, 2023; New York Times
