The test can be used in medical offices and mobile testing sites to identify chemical compounds associated with COVID-19 in less than three minutes, the report said.
The device is about the size of a piece of carry-on luggage, the report said. A study found it accurately identified more than 91 percent of positive samples and nearly 100 percent of negative samples.
“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” Jeff Shuren, MD, 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.”
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