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The Food and Drug Administration (FDA) issued an emergency use authorization for the InspectIR COVID-19 Breathalyzer, which can be used in doctor’s offices, hospitals, and mobile testing sites to quickly identify the virus.
According to officials, the device is 91.2 percent accurate at identifying positive test samples and 99.3 percent accurate at diagnosing negative samples.
The FDA said that the instrument is approximately the size of a piece of carry-on luggage, and the test can be performed by a qualified, trained operator under the supervision of a health care provider licensed or authorized by state law to prescribe tests.
Results can be made available within three minutes.
According to Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health, the device is “yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.”
“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” he added.
"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.”
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