FDA Authorizes First COVID-19 Breath Test

The U.S. Food and Drug Administration (FDA) has issued a new emergency use authorization (EUA) for the InspectIR COVID-19 Breathalyzer. This new device, which was authorized on April 14, has been shown to produce highly accurate COVID-19 test results in a shorter timeframe than traditional PCR tests.

The InspectIR COVID-19 Breathalyzer was designed by InspectIR Systems, a company based in Frisco, Texas. The device uses a process known as gas chromatography gas mass-spectrometry in order to analyze a breath sample given by subjects. The InspectIR breathalyzer then searches the sample for five volatile organic compounds that are associated with the SARS-CoV-2 virus. Most of the volatile organic compounds being searched for belong to the ketone and aldehyde chemical families.

The InspectIR breathalyzer test can be administered in a number of convenient environments including physician’s offices, pop-up testing sites, hospitals, or other healthcare facilities. According to the device instructions, the device must be overseen by an authorized healthcare provider and operated by a trained operator. The device itself is non-invasive and can deliver results in as little as three minutes.

If the InspectIR device detects the volatile organic compounds in a sufficient ratio, it will signal a positive test result. This test result is an unconfirmed or “presumptive” test result that will require confirmation by a PCR test or other molecular test. The real benefit of the InspectIR test, however, is in the negative results.

In the initial study of the InspectIR COVID-19 Breathalyzer, 2,409 individuals were analyzed. Of those analyzed, the device correctly identified positive cases 91.2% of the time and the device correctly excluded negative cases 99.3% of the time. These results were later confirmed in a follow-up clinical study using the omicron variant.

This 99.3% detection rate was later supplemented by an additional test in areas of low concentrations of COVID-19 where the InspectIR COVID-19 Breathalyzer detected 99.6% of negative cases correctly. These results make the InspectIR device invaluable for ruling out negative cases, making it a candidate for future measures to rapidly screen for COVID-19 at large events such as galas, concerts, or theater productions.

Dr. Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said that the EUA for the inspectIR was, “yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.”

Dr. Shuren stated that the FDA is continuing to support the development of new tests for COVID-19 to address the current and future public health needs of the United States.




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