The system separates and identifies chemical mixtures to detect five compounds associated with SARS-CoV-2 infection. A study by InspectIR Breathalyzer found that it accurately identified more than 91% of the positive samples and almost 100% of the negative samples. Similar sensitivity was found in another study focusing on the Omicron coronavirus variant. However, a positive result should be confirmed by a PCR test, the FDA said. “Today’s authorization is another example of the rapid innovation in COVID-19 diagnostic testing,” said Dr. Jeff Suren, director of the FDA’s Center for Apparatus and Radiology Health. “The FDA continues to support the development of new COVID-19 tests aimed at promoting technologies that can help address the current pandemic and better position the United States for the next public health emergency.”
