(Fighting against New Coronary Pneumonia) The US FDA approves the use of breath samples for new coronavirus testing for the first time
China News Agency, San Francisco, April 14th. On the 14th local time, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization, the first approval to use the exhaled breath of sampled people to detect the new coronavirus.
The FDA announced on its official website on the same day that the test method can detect five volatile organic compounds related to new coronavirus infection in the breath exhaled by the tested person.
The device that performs this test is the size of a suitcase and provides test results within 3 minutes.
Sample collection and analysis for this test can be done in the same environment, such as hospitals and other mobile testing sites, the FDA said.
The testing is performed by qualified and trained personnel under the supervision of a health care provider licensed or authorized by state law.
According to the FDA, a study of 2,409 people tested found that InspectIR's tester accurately identified 91.2 percent of positive samples and 99.3 percent of negative samples.
Similar data was obtained from another study on the Omicron virus.
However, positive results obtained by testing exhaled breath should be confirmed by molecular testing.
InspectIR expects to be able to manufacture about 100 of the detectors per week, with each instrument capable of testing about 160 samples per day, the FDA said.
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