The Food and Drug Administration authorized the first over-the-counter test that can detect COVID-19, both strains of influenza, and respiratory syncytial virus using a single nasal swab.
The test is available to people with symptoms consistent with COVID-19, which often mirror those of other respiratory viruses, the FDA said Monday. People can order the tests online, collect a sample at home using a nasal swab, much like the common home COVID-19 test, and send the sample to Labcorp for results delivered online. The test has been authorized for children as young as 2 years old.
COVID-19 DEATHS IN US EXCEED 1 MILLION, CDC SAYS
“While the FDA has now authorized many COVID-19 tests without a prescription, this is the first test authorized for flu and RSV, along with COVID-19, where an individual can self-identify their need for a test, order it, collect their sample and send it to the lab for testing, without consulting a health care professional,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
Monday’s authorization marks a big step forward for the agency, which struggled early in the pandemic to bring accurate tests to market. For instance, the first rapid at-home COVID-19 test was not granted emergency use authorization until November 2020.
“The rapid advances being made in consumer access to diagnostic tests, including the ability to collect your sample at home for flu and RSV without a prescription, brings us one step closer to tests for these viruses that could be performed entirely at home,” Shuren said.
CLICK HERE TO READ MORE FROM THE WASHINGTON EXAMINER
The test’s ability to detect multiple respiratory viruses will be especially helpful starting in the fall, when flu season generally begins. The test is also likely to be a source of comfort for parents sending their children back to school in person, where they are at heightened risk of being exposed. Respiratory syncytial virus is typically seen in children with underlying health conditions and compromised immune systems. It is also the most common cause of pneumonia and bronchiolitis, or inflammation of the lungs' airways, in infants.