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    FDA Authorizes 3-Minute COVID Breathalyzer Test

    • Published
    • 15 April 2022
    • Category
    • News

    The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) today for the InspectIR COVID-19 Breathalyzer, making it the first authorized diagnostic test that detects SARS-CoV-2 in breath samples. The test can be performed in doctor’s offices, clinics, hospitals, mobile testing units and similar sites using an instrument about the size of a piece of carry-on luggage.

    The test must be performed by a qualified, trained operator under the supervision of a health care provider licensed or authorized by state law to prescribe tests. It can provide results in less than three minutes. With the authorization, InspectIR reportedly expects to produce about 100 instruments per week. Each unit can evaluate approximately 160 samples per day. At this level of production, testing capacity using the breathalyzer is expected to increase by approximately 64,000 samples per month.

    “Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “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 breathalyzer’s performance was validated in a study of 2,409 individuals, including those with and without symptoms. The test was shown to have 91.2 percent sensitivity (the percent of positive samples the test correctly identified) and 99.3 percent specificity (the percent of negative samples the test correctly identified). In a population with 4.2 percent of individuals who tested positive for the virus, the test had a negative predictive value of 99.6 percent. This result indicates that people who receive a negative test result are likely truly negative in areas of low disease prevalence. The test performed with similar sensitivity in a follow-up clinical study focused on the Omicron variant.

    The breathalyzer uses a technique called gas chromatography-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 breathalyzer detects the presence of VOC markers of SARS-CoV-2, a presumptive (unconfirmed) positive test result is returned and should be confirmed with a molecular test, such as a PCR test. According to the FDA, negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. Negative results do not rule out infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.

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