covid-19 /

FDA Authorizes First Breathalyzer to Detect COVID-19

Dr. Jeff Shuren said this would 'better position the US for the next public health emergency'


On Thursday, the Food and Drug Administration (FDA) granted emergency use authorization to a new COVID-19 test that uses a sample of a patient’s breath, providing results in less than three minutes. 

The FDA stated the newly authorized InspectIR COVID-19 Breathalyzer would only be available for testing with “a qualified, trained operator under the supervision of a health care provider.” 

In a statement announcing the authorization, the FDA’s top COVID-19 testing official, Dr. Jeff Shuren, said, “The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the U.S. for the next public health emergency.”

The machine was developed in a joint venture between InspectIR Systems LLC (InspectIR) and the University of North Texas College of Science. The innovative technology is housed in a box about the size of a piece of carry-on luggage and was designed to be used in hospitals, doctors’ offices, or mobile testing sites. 

According to the statement of authorization, the FDA said that InspectIR would be capable of producing about 100 instruments weekly. 

The FDA said each unit could evaluate around 160 samples every day, increasing testing by 64,000 every month. 

InspectIR’s technology analyzes a patient’s breath using “gas chromatography gas mass-spectrometry” to detect five compounds generally exhaled when SARS-CoV-2 infects a person. 

The FDA noted that the machines were tested in a study of 2,409 people. The sample group included patients with and without symptoms of the SARS-CoV-2 virus. According to the agency, the device could detect 91.2% of cases. They noted that the false positives occurred in less than 1% of the tests. 

According to the company’s website, InspectIR uses similar technology in other tests to detect drugs on people’s breath.

The federal government has also backed other variations of COVID-19 tests, including at-home kits that utilize a single swab to detect the flu and COVID-19. 

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