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First FDA-cleared Covid-19 breath test


The FDA said the InspectIR Covid-19 Breathalyzer, which is about the size of a carry-on, can be used in doctor’s offices and mobile testing sites. It can show results in less than three minutes.

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 looking at the Omicron coronavirus variant. However, a positive result must be confirmed with a PCR test, the FDA said.

“It’s another tool, and the FDA announcement suggests it’s reasonably accurate and relatively user-friendly,” said Dr. Emily Volk, president of the College of American Pathologists, board-certified anatomical and clinical pathologist, on Friday.

“He’s waiting to see how widely it gets adopted,” Volk said. “It could depend on its cost. »

In an email to CNN on Friday, InspectIR Systems said it was not disclosing the price of the machine or when it would be available.

The agency’s clearance “is yet another example of the rapid innovation happening with diagnostic tests for COVID-19,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. , in a press release. “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. »

CNN’s Jacqueline Howard and Nadia Kounang contributed to this report.

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