The Food and Drug Administration announced Thursday that Americans will be able to find out whether they have COVID-19 with a breathalyzer test.
The FDA granted an emergency use authorization for a test manufactured by InspectIR Systems that collects a breath sample and analyzes chemical compounds linked to 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 negative samples in 99.3% of cases, the FDA said in a release. A similar result was seen in a follow-up study focused on the infectious Omicron variant of the coronavirus.
According to InspectorIR, the test is performed by exhaling into a tube in a manner similar to blowing up a balloon and gives results within three minutes.
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The FDA said the test equipment is about the size of a piece of carry-on luggage, and that the breath test can be performed in doctor’s offices, hospitals and other testing sites.
“Today’s authorization is another example of the rapid innovation that is happening with clinical trials 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 America for the next public health emergency.”
The FDA said that a positive result obtained through the InspectIR COVID-19 respirator should be confirmed by molecular testing.
