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.”
Quick COVID breathalyzer could allow mass screening in public places
© 2022 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission.
FDA authorizes 1st breath test for COVID-19 infection (2022, April 15)
retrieved 15 April 2022
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no
part may be reproduced without the written permission. The content is provided for information purposes only.