FDA Grants Emergency Authorization For First COVID-19 Breathalyzer Test

FDA grants emergency authorization for first COVID breath test | KHQA

Source: USA Today, by Jeanine Santucci

Americans will be able to find out if they have COVID-19 with a breathalyzer test, the Food and Drug Administration announced Thursday.

The FDA granted an emergency use authorization to a test produced by InspectIR Systems that collects a breath sample and analyzes for chemical compounds associated with the coronavirus, the first of its kind to be authorized for use.

In a study of 2,409 people, the test correctly identified a positive COVID infection in 91.2% of cases and correctly identified negative samples 99.3% of the time, the FDA said in a release. A similar result was seen in a follow-up study focused on the contagious omicron variant of the coronavirus.

According to InspectIR, the test is performed by exhaling into a tube in a similar manner to blowing up a balloon and produces results within three minutes.

The FDA said the testing instrument is about the size of a piece of carry-on luggage, and that breath tests can be performed in doctor’s offices, hospitals, and other testing sites.

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

The FDA said a positive result yielded through the InspectIR COVID-19 breathalyzer should be confirmed with a molecular test.

Last Updated 05/25/2022

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