The system separates and identifies chemical mixtures to detect five compounds associated with SARS-CoV-2 infection.
A study of the InspectIR Breathalyzer found that it accurately identified more than 91% of positive samples and nearly 100% of negative samples. Similar sensitivity was found in another study focused on the omicron coronavirus variant. With that said, a positive result must be confirmed with a PCR test, the Food and Drug Administration said.
“It’s another tool, and the FDA’s announcement indicates that it’s reasonably accurate and a relatively easy-to-use tool,” said Dr. Emily Falk, president of the College of American Pathologists, a board-certified anatomical and clinical pathologist.
“He is waiting to see to what extent this will be widely adopted,” Falk said. “It could depend on how expensive it is.”
In an email to CNN on Friday, InspectIR Systems said it will not announce the price of the device or when it will be available.
Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement that the agency’s mandate “is another example of the rapid innovation that is happening with diagnostic tests for COVID-19.” “The FDA continues to support the development of new COVID-19 tests with the goal of developing technologies that can help address the current pandemic and better position the United States in the next public health emergency.”
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