FDA Authorizes First 3 Minute COVID Breath Test

The US Food and Drug Administration (FDA) has authorized the first 3 minute COVID breath test publishing an emergency usage permission on Thursday for the very first equipment that can identify COVID-19 in breathing samples, according to the agency.

According to the FDA, the InspectIR COVID-19 Breathalyzer is roughly the size of a carry-on bag and can be utilized in doctor’s offices, hospitals, and mobile screening locations. The test, which has a turnaround time of less than three minutes, must be performed under the direction of a registered health care provider, reports AP News.

The technology is “yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” according to Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.

The device was 91.2 percent successful in detecting positive test samples and 99.3% effective in recognizing negative test samples, according to the FDA.

“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.”

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