ISRAEL AT WAR - DAY 55

search

In first, US authorities authorize COVID breathalyzer test

FDA says InspectIR device can provide results in less than 3 minutes, has over 90 percent accuracy in identifying samples as negative or positive

A sign for the Food and Drug Administration is seen in Silver Spring, Maryland, on December 10, 2020. (AP Photo/Manuel Balce Ceneta)
A sign for the Food and Drug Administration is seen in Silver Spring, Maryland, on December 10, 2020. (AP Photo/Manuel Balce Ceneta)

WASHINGTON — The Food and Drug Administration on Thursday issued an emergency use authorization for what it said is the first device that can detect COVID-19 in breath samples.

The InspectIR COVID-19 Breathalyzer is about the size of a piece of carry-on luggage, the FDA said, and can be used in doctor’s offices, hospitals and mobile testing sites. The test, which can provide results in less than three minutes, must be carried out under the supervision of a licensed health care provider.

Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, called the device “yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.”

The FDA said the device was 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples.

“InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day,” the agency said. “At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.”

read more:
Never miss breaking news on Israel
Get notifications to stay updated
You're subscribed
image
Register for free
and continue reading
Registering also lets you comment on articles and helps us improve your experience. It takes just a few seconds.
Already registered? Enter your email to sign in.
Please use the following structure: example@domain.com
Or Continue with
By registering you agree to the terms and conditions. Once registered, you’ll receive our Daily Edition email for free.
Register to continue
Or Continue with
Log in to continue
Sign in or Register
Or Continue with
check your email
Check your email
We sent an email to you at .
It has a link that will sign you in.