US authorises new COVID-19 breath test
Posted On April 15, 2022
The US Food and Drug Administration has issued an emergency use authorisation for what it said is the first device that can detect COVID-19 in breath samples.
The InspectIR COVID-19 Breathalyser 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.
The test, which can provide results in less than three minutes, 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 per cent accurate at identifying positive test samples and 99.3 per cent 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.”