FDA Grants Emergency Use Authorization To COVID-19 Breathalyzer Test

The Food and Drug Administration (FDA) announced on Thursday that it had authorized the first test to detect COVID-19 through breath for emergency use.

The InspectIR COVID-19 Breathalyzer is able to identify five volatile organic compounds tied to the coronavirus in a person’s breath by using a technique known as gas chromatography gas mass-spectrometry, delivering results in less than three minutes, according to the FDA.

The agency said that in a study of 2,409 people, which included both people with and without symptoms, the test had a 99.3 percent specificity rate, which measures the percent of correctly identified negative test samples.

The FDA also noted that the InspectIR COVID-19 Breathalyzer had a 91.2 percent sensitivity rate, which measures the percent of correctly identified positive test samples.

Still, the health agency said that a molecular test should be used to confirm positive test results returned by the COVID-19 breath test.

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

Bloomberg (4/14, Muller) reports, “A COVID-19 breathalyzer test with the ability to provide diagnostic results in three minutes has won emergency-use authorization from the U.S. Food and Drug Administration, the agency announced Thursday.” The test made by InspectIR Systems “is authorized for those 18 and older and in settings where samples are both collected and analyzed, such as doctor’s offices, hospitals or mobile testing sites.” The FDA “said the test was validated in a study of 2,409 people, where it correctly identified 91.2% of positive samples and 99.3% of negative samples.”

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