The U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the first ever COVID-19 diagnostic test using breath samples.
Through the InspectIR COVID-19 Breathalyzer, the test “can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals and mobile testing sites, using an instrument about the size of a piece of carry-on luggage,” the drug agency said in a release.
“The test is performed by a qualified, trained operator under the supervision of a health care provider licensed or authorized by state law to prescribe tests and can provide results in less than three minutes,” it added.
Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health, said the authorization is 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,” he said.
The InspectIR COVID-19 Breathalyzer uses a technique called gas chromatography gas mass-spectrometry (GC-MS) to separate and identify chemical mixtures.
