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The first device that can detect Covid-19 in breath samples has been given an emergency use authorization by the Food and Drug Administration. The InspectIR Covid-19 Breathalyzer is about the size of a piece of carry-on luggage, the FDA said, and can be used in doctor's offices, hospitals and mobile testing sites, according to AP report.
Notably, the test can provide results in less than three minutes and must be carried out under the supervision of a licensed health care provider. Dr Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, called the device “yet another example of the rapid innovation occurring with diagnostic tests for Covid-19."
The FDA said the device was 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples. “InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day," the agency said.
“At this level of production, testing capacity using the InspectIR Covid-19 Breathalyzer is expected to increase by approximately 64,000 samples per month."
The FDA is also supporting the development of more testing capabilities, he said. The company, which focuses on portable opioid and cannabis detection tools, expects to be able to produce approximately 100 of the devices each week, which can be used to evaluate about 160 samples per day. On its website, the company says the breathalyzer is the first such device available for commercial use, according to Bloomberg report.
The FDA said the test can only be administered by qualified, trained operators under the supervision of health care professionals with state authorization to prescribe tests. InspectIR Systems did not immediately respond to requests for additional information regarding the device’s cost or the expected level of demand.
(With inputs from agencies)