FDA grants emergency use authorization to COVID-19 Breathalyzer test

April 14 (UPI) -- The U.S. Food and Drug Administration on Thursday granted emergency use authorization to the first COVID-19 test to use breath samples.

The FDA approved the InspectIR COVID-19 Breathalyzer for use in medical facilities and mobile testing sites.

The device, which is about the size of a piece of carry-on luggage, uses a technique called gas chromatography gas mass-spectrometry to separate and identify chemical compounds associated with COVID-19 infections.

According to the FDA, InspectIR can produce 100 instruments per week to evaluate about 160 samples per day, providing results in less than 3 minutes.

In a study, the InspectIR Breathalyzer accurately identified 91.2% of positive tests and 99.3% of negative tests.

The FDA said that a positive test should be confirmed with a molecular PCR test.

"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."