FDA approves three-minute COVID breath test
The FDA said the test showed that people who receive a negative result are likely to be truly negative.
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The U.S. Food and Drug Administration on Thursday gave its first emergency use authorization to a COVID-19 test that can detect the virus in a person's breath in minutes.
The InspectIR COVID-19 Breathalyzer test detects chemical compounds in the breath samples and uses "an instrument about the size of a piece of carry-on luggage," according to the FDA.
A qualified healthcare provider will administer the test and provide the results within three minutes. One machine is expected to be able to evaluate about 160 samples per day, and InspectIR plans to produce about 100 breathalyzers each week.
"Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19," FDA official Dr. Jeff Shuren said in a press release. "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."
The FDA said the test showed that people who receive a negative result are likely to be truly negative when they are tested in an area with low disease prevalence. The results also held up when tested against the Omicron variant of COVID-19.
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