The FDA said the InspectIR Covid-19 hand luggage tester could be used in medical offices and mobile testing sites. It can give results in less than three minutes.
The system separated and identified chemical mixtures to detect five compounds associated with SARS-CoV-2 infection.
An InspectIR Breathalyzer study found that it accurately identified more than 91% of positive samples and almost 100% of negative samples. Similar susceptibility was found in another study focusing on the Omicron coronavirus variant. However, a positive result must be confirmed by PCR test, the FDA said.
“Today’s authorization is another example of the rapid innovation that is happening with diagnostic tests for COVID-19,” said Dr. Jeff Schuren, director of the FDA’s Center for Devices and Radiological Health. “The FDA continues to support the development of new tests for COVID-19 to improve technologies that can help address the current pandemic and better position the United States for the next public health emergency.”
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