New Delhi: Nearly two years after the pandemic broke out, a device that can detect COVID-19 in breath samples was granted emergency use authorization by the Food and Drug Administration on Thursday.
What is the device about?
The InspectIR Covid-19 Breathalyzer carry-on is about the size of a piece of luggage, the FDA said, and can be used in places such as doctor’s offices, hospitals and mobile testing sites, according to an AP report.
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The test is said to provide results in less than three minutes and should be done 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 “another example of the rapid innovation that accompanies clinical trials for COVID-19”.
What is the accuracy of the device?
The FDA said the device was 91.2 percent accurate in identifying positive test samples and 99.3 percent 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 approximately 64,000 samples per month.” In the meantime, the FDA is also working on developing more testing capabilities, Shuren 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.
According to a Bloomberg report, the company’s website states that the breath analyzer is the first such device available for commercial use.