A Covid-19 breathalyzer test with the ability to provide diagnostic results in three minutes has won emergency-use authorization from the U.S. Food and Drug Administration, the agency announced Thursday.
The test, made by Frisco, Texas-based InspectIR Systems, is authorized for those 18 and older and in settings where samples are both collected and analyzed, such as doctor’s offices, hospitals or mobile testing sites. The device is about the size of a piece of carry-on luggage, the FDA said, and works by detecting chemical compounds in breath samples associated with SARS-CoV-2 infection.
The agency said the test was validated in a study of 2,409 people, where it correctly identified 91.2% of positive samples and 99.3% of negative samples. It performed similarly in follow-up tests focused on the omicron variant. The breathalyzer’s sensitivity is comparable to that of rapid antigen tests, studies show.
“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 the statement. The FDA is also supporting the development of more testing capabilities, he said.
The company, which focuses on portable opioid and cannabis detection tools, expects to be able to produce approximately 100 of the devices each week, which can be used to evaluate about 160 samples per day. On its website, the company says the breathalyzer is the first such device available for commercial use.
The FDA said the test can only be administered by qualified, trained operators under the supervision of health care professionals with state authorization to prescribe tests.
InspectIR Systems did not immediately respond to requests for additional information regarding the device’s cost or the expected level of demand.