Current:Home > MyRobert Brown|FDA authorizes the first at-home test for COVID-19 and the flu -Elevate Profit Vision
Robert Brown|FDA authorizes the first at-home test for COVID-19 and the flu
EchoSense View
Date:2025-04-07 23:31:16
The Robert BrownFood and Drug Administration issued an emergency use authorization on Friday for the first at-home test that can simultaneously detect both COVID-19 and the flu.
With a shallow nasal swab, the single-use kit can provide results within 30 minutes indicating whether a person is positive or negative for COVID, as well as influenza A and influenza B, which are two common strains of the flu.
People 14 and older can generally perform the test on themselves, the FDA says. Those between the ages of 2 and 13 can get results with the help of an adult.
Dr. Jeff Shuren, the director of the FDA's Center for Devices and Radiological Health, called the test as a "major milestone."
"We are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs," Shuren said in a statement.
The test was developed by Lucira Health, a California-based company that was also the first to receive FDA approval for at-home rapid COVID tests back in 2020.
According to the FDA, in people showing symptoms, the Lucira home kit accurately detected 88.3% of COVID infections and 90.1% of influenza A infections. The test can identify influenza B in lab studies, the FDA said. But because there are not enough cases of the virus circulating in real-world settings, further testing will be required, officials said.
The FDA also warned that, similar to all rapid diagnostic tests, there is a risk of false positive and false negative results. The agency says individuals who test positive for COVID or the flu should take appropriate precautions and follow-up with a health care provider, while people who receive a negative result of either COVID or influenza B should confirm it with a molecular test preformed in a lab.
Individuals who test negative but continue to experience symptoms of fever, cough or shortness of breath should also follow up with their health care provider in case of other respiratory viruses, the FDA said.
The dual-purposed test comes after a surge of COVID, the flu and respiratory syncytial virus -- or RSV — that strained hospitals across the country last fall.
"The collective impact of COVID-19, flu and RSV underscore the importance of diagnostic tests for respiratory viruses," the FDA said in a statement.
Over the past few weeks, COVID-related deaths and hospitalizations have begun to fall, according to the latest data from the Centers for Disease Control and Prevention. Similarly, rates of flu and RSV-related hospitalizations have been going down, the CDC found.
veryGood! (77793)
Related
- US appeals court rejects Nasdaq’s diversity rules for company boards
- 2024 NFL draft rankings: Caleb Williams, Marvin Harrison Jr. lead top 50 players
- Get an Extra 20% off Kate Spade Outlet & Score This Chic $299 Crossbody for $65, Plus More Deals
- What to know about Elon Musk’s ‘free speech’ feud with a Brazilian judge
- Toyota to invest $922 million to build a new paint facility at its Kentucky complex
- Washington man pleads guilty to groping woman on San Diego to Seattle flight
- Ex-Shohei Ohtani interpreter negotiating guilty plea with federal authorities, per report
- Kansas City Chiefs Player Rashee Rice Turns Himself In to Police Over Lamborghini Car Crash
- Trump's 'stop
- Will John Legend and Chrissy Teigen Have Another Baby? They Say…
Ranking
- What do we know about the mysterious drones reported flying over New Jersey?
- Maryland 'Power couple' wins $2 million with 2 lucky tickets in the Powerball drawing
- 2024 NFL draft rankings: Caleb Williams, Marvin Harrison Jr. lead top 50 players
- MLB Misery Index: AL Central limping early with White Sox, Guardians injuries
- Paula Abdul settles lawsuit with former 'So You Think You Can Dance' co
- Key events in OJ Simpson’s fall from sports hero and movie star
- 10 Things to Remember about O.J. Simpson
- 1 killed, 5 injured in shooting in Northeast Washington DC, police search for suspects
Recommendation
'Squid Game' without subtitles? Duolingo, Netflix encourage fans to learn Korean
Canada at risk of another catastrophic wildfire season, government warns
Prince Harry and Duchess Meghan announce two new Netflix series, including a lifestyle show
Where are they now? Key players in the murder trial of O.J. Simpson
Man can't find second winning lottery ticket, sues over $394 million jackpot, lawsuit says
Robert De Niro and Tiffany Chen attend White House state dinner, Paul Simon performs: Photos
Ex-Shohei Ohtani interpreter negotiating guilty plea with federal authorities, per report
Caitlin Clark, Angel Reese, Cameron Brink headline invitees for 2024 WNBA draft