The FDA Authorizes First COVID-19 Breath Test—Here’s What You Need to Know

The non-invasive testing method provides results in less than three minutes.

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  • The FDA authorized the use of the first COVID-19 breath test.
  • A device called the InspectIR Covid-19 Breathalyzer detects chemical compounds in breath samples associated with the virus.
  • The device is the size of carry-on luggage and is permitted for use at hospitals, doctor’s offices, and testing sites. Results can be available in less than three minutes.

    At this point, over two years into the pandemic, you’ve probably endured the discomfort of swabbing your nose a time or two to test for COVID-19. Although testing has come a long way since 2020, a new milestone is here: The Food and Drug Administration (FDA) just authorized the use of the first COVID-19 breath test, called the InspectIR Covid-19 Breathalyzer.

    According to a statement released by the agency, the test, performed by a device about the size of carry-on luggage, detects chemical compounds in breath samples associated with a SARS-CoV-2 (the virus that causes COVID-19) infection. The FDA issued emergency use authorization for the device, permitting its operation by trained professionals and health care providers in doctors’ offices, hospitals, and mobile testing sites. From start to finish, test results can be available in less than three minutes.

    “Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health said in the statement. “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.”

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    How effective is the COVID-19 breath test?

    The efficacy of the innovative machine was studied among 2,409 individuals, including those with and without symptoms. The breathalyzer was shown 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).

    The study also showed promising results in preventing false negative tests—in a population with only 4.2% of individuals who were positive for the virus, it had a negative predictive value of 99.6%, meaning those who tested negative were likely truly negative in areas of low disease prevalence. Similar overall results were garnered in a follow-up study that examined the omicron variant.

    How does the COVID-19 breath test work?

    A video demonstration released by InspectIR displays the non-invasive breath testing process. Using the amount of air it takes to inflate a small balloon, patients blow through a single-use sanitary straw, and the results are then displayed on a small touch screen. The device stores no biological materials, as the breath particles are heated and ionized after each use.

    According to the FDA press release, the device uses a technique called gas chromatography gas mass-spectrometry (GC-MS) to separate and identify chemical mixtures and rapidly detect five Volatile Organic Compounds (VOCs) associated with SARS-CoV-2 infection in exhaled breath. When the InspectIR COVID-19 Breathalyzer finds the presence of VOC markers of the virus that causes COVID-19, a presumptive (unconfirmed) positive test result is returned and should be confirmed with a molecular test (like a PCR test). Officials warn that negative results should be considered in the context of a patient’s recent exposures, history, and symptoms consistent with coronavirus infection, as they do not rule out infection and should not be used as the only basis for treatment or decisions.

    The FDA says that, moving forward, InspectIR expects to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day. Such output will increase testing capacity by around 64,000 samples per month.

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