The first device that can detect COVID-19 in breath samples has been granted 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. AP report good.
Notably, the test can provide results in less than three minutes and should be done under the supervision of a licensed health care provider. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, called the device “another example of the rapid innovation that accompanies clinical trials for diagnosis.” COVID-19,
The FDA said the device was 91.2% accurate in identifying positive test samples and 99.3% accurate in identifying negative test samples, “The inspector expects to be able to produce about 100 instruments per week, which can be used to evaluate approximately 160 samples per day,” the agency said.
“At this stage of production, the testing capacity using the InspectIR Covid-19 Breathalyzer is expected to increase to around 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 about 100 devices each week, which can be used to evaluate about 160 samples per day. On its website, the company states that the breath analyzer is the first tool available for commercial use, according to bloomberg report good.
The FDA said the test can only be administered by qualified, trained operators under the supervision of health care professionals with state authority to prescribing tests. InspectIR Systems did not immediately respond to requests for additional information about the cost of the device or the expected level of demand.
(with inputs from agencies)