FDA authorizes first COVID-19 breath test

The Food and Drug Administration (FDA) authorized the first test to detect COVID-19 through breath for emergency use.


The InspectIR COVID-19 Breathalyzer — which is about the size of a carry-on piece of luggage — is able to identify five volatile organic compounds tied to the coronavirus in a person’s breath using a technique known as gas chromatography gas mass-spectrometry, delivering results within 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.


About 100 of the InspectIR COVID-19 Breathalyzers, each of which the FDA said can be used to test roughly 160 samples per day, are anticipated to be made each week.