The US Food and Drug Administration said the “Inspect IR COVID-19 Breathalyzer” is the size of a piece of carry-on baggage and can be used in doctors’ offices, hospitals and mobile testing sites.
The test, which can provide results in less than three minutes, must be performed under the supervision of a licensed health care provider.
Dr. Jeff Shuren, director of the Food and Drug Administration’s Center for Devices and Radiological Health, described the device as “another example of the rapid innovation that is happening with diagnostic tests for 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 agency stated: “Inspect IR expects to be able to produce approximately 100 devices per week, each of which can be used to evaluate approximately 160 samples per day. At this level of production, testing capacity is expected to increase with the use of The new device received approximately 64,000 samples per month.
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