FDA Authorizes Breath Test for COVID-19 Diagnosis
The breathalyzer is the size of a piece of carry-on luggage.
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The US Food and Drug Administration on Thursday issued emergency use authorization for a COVID-19 diagnostic test using breath samples. The InspectIR COVID-19 Breathalyzer test detects five chemical compounds found in the exhaled breath of COVID patients.
The test is conducted using an instrument the size of "a piece of carry-on luggage" in hospitals, clinics and testing sites, the FDA said in a press release. Each instrument can be used to test 160 samples per day.
"Today's authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19," said Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health.
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The InspectIR COVID-19 Breathalyzer was found to accurately identify positive COVID cases 91.2% of the time in a study of 2,409 people. It was 99.3% accurate when correctly identifying negative samples.
Positive results should be confirmed with molecular tests, the FDA said.