The Food and Drug Administration has granted an emergency use authorization for the first breath test to detect COVID-19. The breathalyzer is made by InspectIR Systems and can provide results within just three minutes.
The breathalyzer is the size of a small suitcase and can be easily transported for use at mobile testing sites or medical offices. The machine can identify five compounds associated with COVID-19 and has an accuracy rating of 91% for positive tests and nearly 100% for negative tests.
"Accuracy has been an issue with COVID-19 testing since the beginning of the crisis. Our device is specifically designed for trace detection in the high part-per-trillion. We believe it will provide the most accurate results on the market. There are few viable non-invasive detection tools available today," said InspectIR Systems COO John Redmond.
The FDA said that positive results should still be confirmed with a PCR test.
"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."
InspectIR Systems said the machine can conduct about 160 tests per day and could boost testing capacity in the United States by about 64,000 tests per month.