The Food and Drug Administration on Thursday authorized the first test that can detect COVID-19 in breath samples.

What You Need To Know

  • The FDA on Thursday authorized the first COVID-19 test that can detect the virus in breath samples

  • The InspectIR COVID-19 Breathalyzer is about the size of a piece of carry-on luggage and can provide results in less than three minutes

  • The FDA said the device was 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples

  • Other COVID-19 tests typically use saliva or nasal swabs

The InspectIR COVID-19 Breathalyzer is about the size of a piece of carry-on luggage, the FDA said, and can be used in doctor’s offices, hospitals and mobile testing sites. The test, which can provide results in less than three minutes, must be carried out under the supervision of a licensed health care provider.

Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, called the device “yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.”

"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," Shuren added.

The FDA said the device was 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples.

“InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day,” the agency said. “At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.”

Other COVID-19 tests typically use saliva or nasal swabs.