The Food and Drug Administration on Thursday issued an emergency use authorization for what it said is the first device that can detect COVID-19 in breath samples.
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. 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% 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.”
A Montana judge on Monday sided with young environmental activists who said state agencies were violating their constitutional right to a clean and healthful environment by permitting fossil fuel development without considering its effect on the climate.
Alzheimer’s mainly affects the elderly, who are eligible for Medicare, but people under 65 — even, rarely, as young as their 30s — also can get diagnosed. They are more likely to have commercial coverage.
Some doctors say the drug should be held for three weeks before sedation to accommodate the delayed emptying of the stomach, which can cause patients to inhale food and liquid into their lungs.
