Lucira Well being
The Meals and Drug Administration issued an emergency use authorization on Friday for the primary at-home take a look at that may concurrently detect each COVID-19 and the flu.
With a shallow nasal swab, the single-use package can present outcomes inside half-hour indicating whether or not an individual is constructive or damaging for COVID, in addition to influenza A and influenza B, that are two widespread strains of the flu.
Folks 14 and older can typically carry out the take a look at on themselves, the FDA says. These between the ages of two and 13 can get outcomes with the assistance of an grownup.
Dr. Jeff Shuren, the director of the FDA’s Middle for Units and Radiological Well being, referred to as the take a look at as a “main milestone.”
“We’re wanting to proceed advancing higher entry to at-home infectious illness testing to finest help public well being wants,” Shuren stated in an announcement.
The take a look at was developed by Lucira Well being, a California-based firm that was additionally the primary to obtain FDA approval for at-home fast COVID checks again in 2020.
In line with the FDA, in individuals exhibiting signs, the Lucira dwelling package precisely detected 88.3% of COVID infections and 90.1% of influenza A infections. The take a look at can determine influenza B in lab research, the FDA stated. However as a result of there aren’t sufficient circumstances of the virus circulating in real-world settings, additional testing shall be required, officers stated.
The FDA additionally warned that, just like all fast diagnostic checks, there’s a danger of false constructive and false damaging outcomes. The company says people who take a look at constructive for COVID or the flu ought to take applicable precautions and follow-up with a well being care supplier, whereas individuals who obtain a damaging results of both COVID or influenza B ought to affirm it with a molecular take a look at preformed in a lab.
People who take a look at damaging however proceed to expertise signs of fever, cough or shortness of breath must also comply with up with their well being care supplier in case of different respiratory viruses, the FDA stated.
The twin-purposed take a look at comes after a surge of COVID, the flu and respiratory syncytial virus — or RSV — that strained hospitals throughout the nation final fall.
“The collective impression of COVID-19, flu and RSV underscore the significance of diagnostic checks for respiratory viruses,” the FDA stated in an announcement.
Over the previous few weeks, COVID-related deaths and hospitalizations have begun to fall, in keeping with the newest knowledge from the Facilities for Illness Management and Prevention. Equally, charges of flu and RSV-related hospitalizations have been taking place, the CDC discovered.