The US Food and Drug Administration (FDA) has announced that it has granted emergency use approval for the first test device that can detect COVID-19 by breathing.
In a statement, the FDA reported that the device called InspectIR COVID-19 Breath Meter is the size of a small suitcase that can be taken inside an airplane cabin and can be used in doctor’s offices, hospitals and mobile testing centers. The test, which yields results in less than three minutes, must be administered under the supervision of licensed healthcare providers.
Director of the FDA’s Center for Devices and Radiology Health, Dr. Jeff Shuren described the device as “another example of rapid innovation in testing used to diagnose COVID-19.”
According to FDA officials, the accuracy rate of the device in detecting positive test results is 91.2 percent, and this rate is 99.3 percent in negative tests.
“InspectIR plans to manufacture 100 devices per week. Each of them can evaluate 160 samples per day,” said the FDA, “At this production level, the test capacity using the InspectIR COVID-19 Breather will increase by 64 thousand samples per month.”