A breathalyzer device designed to detect COVID-19 in patients was granted emergency use authorization by the Food and Drug Administration on Thursday. The first breath test for the virus collects a sample in a manner similar to blowing up a balloon, and can be analyzed for results in under three minutes. “Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for Covid-19,” Jeff Shuren, the director of the F.D.A.’s Center for Devices and Radiological Health, said in a statement. The company behind the test, InspectIR, reported that, in a study of just under 2,500 people, it could correctly detect a COVID-19 infection 91.2 percent of the time. (The FDA noted that any positive results should then be “confirmed with a molecular test.”) Negative samples were correctly identified in 99.3 percent of cases. The testing apparatus, to be used only “by a qualified, trained operator under the supervision of a health care provider,” is “about the size of a piece of carry-on luggage,” the FDA said. InspectIR expects that a single machine can be used to evaluate roughly 160 test samples a day.
