Tuesday, February 27, 2024
HomeHealthFDA authorizes the primary at-home take a look at for COVID and...

FDA authorizes the primary at-home take a look at for COVID and the flu : NPR

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Lucira Well being, which developed the dual-purposed diagnostic take a look at, stated it may possibly present a constructive outcome as quick as 11 minutes and a unfavorable lead to about half-hour.

Lucira Well being


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Lucira Well being


Lucira Well being, which developed the dual-purposed diagnostic take a look at, stated it may possibly present a constructive outcome as quick as 11 minutes and a unfavorable lead to about half-hour.

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 unfavorable for COVID, in addition to influenza A and influenza B, that are two frequent strains of the flu.

Individuals 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 Gadgets and Radiological Well being, known as the take a look at as a “main milestone.”

“We’re wanting to proceed advancing larger entry to at-home infectious illness testing to finest assist 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 speedy COVID exams again in 2020.

In response to the FDA, in individuals displaying signs, the Lucira residence 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 usually are not sufficient instances of the virus circulating in real-world settings, additional testing will likely be required, officers stated.

The FDA additionally warned that, much like all speedy diagnostic exams, there’s a threat of false constructive and false unfavorable outcomes. The company says people who take a look at constructive for COVID or the flu ought to take acceptable precautions and follow-up with a well being care supplier, whereas individuals who obtain a unfavorable results of both COVID or influenza B ought to verify it with a molecular take a look at preformed in a lab.

People who take a look at unfavorable however proceed to expertise signs of fever, cough or shortness of breath also needs to 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 affect of COVID-19, flu and RSV underscore the significance of diagnostic exams for respiratory viruses,” the FDA stated in an announcement.

Over the previous few weeks, COVID-related deaths and hospitalizations have begun to fall, based on the most recent information from the Facilities for Illness Management and Prevention. Equally, charges of flu and RSV-related hospitalizations have been happening, the CDC discovered.

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