Sat 16 April 2022:
The US Food and Drug Administration (FDA) granted emergency use authorization Thursday for the first ever COVID-19 diagnostic test using breath samples.
Through the InspectIR COVID-19 Breathalyzer, the test “can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals and mobile testing sites, using an instrument about the size of a piece of carry-on luggage,” the drug agency said in a release.
“The test is performed by a qualified, trained operator under the supervision of a health care provider licensed or authorized by state law to prescribe tests and can provide results in less than three minutes,” it added.
In a study of 2,409 people, the test correctly identified a positive COVID infection in 91.2% of cases and correctly identified negative samples 99.3% of the time, the FDA said in a release. A similar result was seen in a follow-up study focused on the contagious omicron variant of the coronavirus.
According to InspectIR, the test is performed by exhaling into a tube in a similar manner to blowing up a balloon and produces results within three minutes.
Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health, said the authorization is another example of the rapid innovation occurring with diagnostic tests for COVID-19.
“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,” he said.
The InspectIR COVID-19 Breathalyzer uses a technique called gas chromatography gas mass-spectrometry (GC-MS) to separate and identify chemical mixtures.
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