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FDA issues emergency use authorization for first COVID-19 breath test


WASHINGTON — The U.S. Food and Drug Administration has granted emergency use authorization for the first Covid-19 test that detects chemical compounds associated with the coronavirus in the breath, the agency announced Thursday.

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.

“Today’s clearance is 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.”

The-CNN-Wire
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