NEWS: First COVID-19 Breath Test Authorized By the FDA

To ensure we are equipping our readers with all the information they need, we will continue to report on all travel, safety, and COVID-related news that could impact a Disney Parks visit.

The situation with COVID-19 continues to change and develop, and certain rules, regulations, and testing procedures get introduced or changed along with those developments.

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Recently, we’ve shared how the Centers for Disease Control and Prevention has extended the face mask mandate on planes and more in the U.S., and how levels of the BA.2 COVID-19 subvariant are increasing in the wastewater in areas near Disney World. But now we’ve got another update related to COVID-19, specifically in regard to COVID-19 testing.

According to a press release shared on the website for the U.S. Food and Drug Administration (“FDA”), the FDA has granted “emergency use authorization” for the first COVID-19 breath test. The test is able to identify “chemical compounds in breath samples” that are associated with the COVID-19 infection.

For now, the test can be performed in places where the patient specimen is both collected and analyzed. The FDA specifies that this would include doctor’s offices, hospitals, and mobile testing sites.

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The test is authorized to be performed by a “qualified, trained operator under the supervision of a health care provider licensed or authorized by state law to prescribe tests.”

Just how big is the equipment that is used for this test? According to the FDA, it is about the size of a piece of carry-on luggage. The test can provide results in a pretty quick manner — in less than 3 minutes.

InspectIR Covid-19 Breathalyzer | Image Obtained via CNN

Jeff Shuren, M.D., J.D., who is the director of the FDA’s Center for Devices and Radiological Health, has 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 breath test uses equipment known as the “InspectIR COVID-19 Breathalyzer.” Its performance was validated in a study that featured over 2,000 people, including people with symptoms and people without symptoms. The study showed this breathalyzer to have “91.2% sensitivity (the percent of positive samples the test correctly identified) and 99.3% specificity (the percent of negative samples the test correctly identified). ”

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According to the FDA, the breathalyzer uses a technique to separate and identify certain chemical mixtures, and then quickly detect 5 organic compounds associated with COVID-19. When the breathalyzer detects the presence of certain volatile organic compounds associated with COVID-19, a presumptive positive test is returned and it should be “confirmed with a molecular test.”

InspectIR is expected to produce about 100 instruments per week, and those can be used to evaluate about 160 samples each day.