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FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples
The FDA recently announced it had issued an emergency use authorization for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with SARS-CoV-2 infection.
©MohamadFaisal/AdobeStock
The US Food and Drug Administration (FDA) recently issued an emergency use authorization for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with SARS-CoV-2 infection.
The InspectIR COVID-19 Breathalyzer test (InspectIR Systems) provides results in under 3 minutes, according to the April 14, 2022, FDA press release.
The authorization “is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, in the press release. “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 agency’s decision was based on a study of 2409 persons with and without symptoms of COVID-19. Results showed the test performed with 91.2% sensitivity, 99.3% specificity, and a negative predictive value of 99.6%. The test yielded similar sensitivity in a follow-up trial that focused on the omicron variant, according to the FDA.
The InspectIR COVID-19 Breathalyzer uses gas chromatography gas mass-spectrometry to separate and identify chemical mixtures and quickly detect 5 volatile organic compounds associated with SARS-CoV-2 infection in exhaled breath.
The FDA said that the test is not meant to be used as “the sole basis for treatment or patient management decisions.” Positive results should be confirmed with molecular testing, and negative results should be considered in the context of a patient’s recent exposure, history, and the presence of signs and symptoms of COVID-19, the agency said.
The manufacturer expects to be able to produce approximately 100 testing instruments per week, which each can be used to evaluate about 160 breath samples per day, according to the FDA. At this level of production, testing capacity is expected to increase by about 64 000 samples per month.
