JUST IN: The FDA has granted emergency use authorization to the first Covid-19 breath test.
The system separates and identifies chemical mixtures to detect five compounds associated with SARS-CoV-2 infection.A study of the InspectIR Breathalyzer found it accurately identified more than 91% of positive samples and nearly 100% of negative samples. Similar sensitivity was found in another study that focused on the Omicron coronavirus variant. However, a positive result should be confirmed with a PCR test, the FDA said.
“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “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.”The-CNN-Wire ™ & © 2022 Cable News Network, Inc.
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