WASHINGTON -- The US Food and Drug Administration has granted emergency use authorization to the first Covid-19 test that spots chemical compounds associated with the coronavirus in breath, the agency said Thursday.
The FDA said the InspectIR Covid-19 Breathalyzer, which is about the size of a piece of carry-on luggage, can be used in medical offices and mobile testing sites. It can give results in less than three minutes.
[Ads /]
The system separates and identifies chemical mixtures to detect five compounds associated with SARS-CoV-2 infection.
A study of the InspectIR Breathalyzer found it accurately identified more than 91% of positive samples and nearly 100% of negative samples. Similar sensitivity was found in another study that focused on the Omicron coronavirus variant. However, a positive result should be confirmed with a PCR test, the FDA said.
"Today's authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19," Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. "The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the U.S. for the next public health emergency."
[Ads /]
The-CNN-Wire
& 2022 Cable News Network, Inc., a WarnerMedia Company. All rights reserved.