FDA approves first COVID-19 breath test for emergency use

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. 

“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 InspectIR COVID-19 Breathalyzer, which the FDA said was about the size of a piece of carry-on luggage, will be able to be used in places like mobile testing sites, hospitals and doctor’s offices, the agency said.

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.