First COVID breath test gets emergency clearance from FDA
Americans will be able to tell if they have COVID-19 through a breathalyzer, the Food and Drug Administration announced Thursday.
The FDA has granted emergency use authorization for a test produced by InspectIR Systems that collects a breath sample and analyzes chemical compounds associated with the coronavirus, the first of its kind to be cleared for use.
In a study of 2,409 people, the test correctly identified positive COVID infection in 91.2% of cases and correctly identified negative samples in 99.3% of cases, the FDA said in a statement. 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 similar to inflating a balloon and produces results in three minutes.
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The FDA said the test instrument was about the size of a carry-on and breath tests could be performed in doctor’s offices, hospitals and other testing sites.
“Today’s clearance is another example of the rapid innovation that is occurring with diagnostic tests for COVID-19,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “The FDA continues to support the development of new COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the United States for the next public health emergency.”
The FDA said a positive result obtained with the InspectIR COVID-19 breathalyzer should be confirmed by molecular testing.
USA Today
