The U.S. Food and Drug Administration on Thursday granted an emergency use authorization for the first COVID-19 test that can detect the virus in breath samples within minutes.
In a news release, the FDA said the InspectIR COVID-19 Breathalyzer was “about the size of a piece of carry-on luggage.”
“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 a statement.
Today, FDA issued an EUA for the first #COVID19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection. https://t.co/xW2ls1a7mg pic.twitter.com/jqsNmrcIXQ
— U.S. FDA (@US_FDA) April 14, 2022
The instrument can be used in a doctor’s office, hospitals and mobile testing sites, The New York Times reported. A single machine can analyze about 160 samples per day, according to the newspaper.
The test, which can provide results in less than three minutes, must be carried out under the supervision of a licensed health care provider, the FDA said.
The FDA said the device was 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples, according to The Associated Press.
The system separates and identifies chemical mixtures to detect five compounds associated with the SARS-CoV-2 infection, CNN reported.
The FDA cautioned in its news release that negative tests “should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19″ because they do not completely rule out an infection, and noted that the device “should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.”
InspectIR expects to be able to produce about 100 machines per week, the Times reported.
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