Infectious Disease

FDA authorizes first breath test for COVID-19

April 15, 2022

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The FDA recently announced that it has issued an emergency use authorization for the first diagnostic test that detects SARS-CoV-2 in breath samples.

The InspectIR COVID-19 Breathalyzer test (InspectIR Systems) provides results in under 3 minutes, according to an FDA press release.

The FDA has issued an emergency use authorization for the first diagnostic test that detects SARS-CoV-2 in breath samples. Source: Adobe Stock.

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

“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 US for the next public health emergency,” he said in the release.

The authorization was based on a study of more than 2,400 individuals with and without symptoms of COVID-19. In the study, 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 detect volatile organic compounds associated with SARS-CoV-2.

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 recent exposure, history and the presence of signs and symptoms of COVID-19, the agency said.

The manufacturer anticipates it will be able to produce approximately 100 testing instruments per week, each of which can be used to evaluate about 160 breath samples per day, the FDA said in the release. Testing capacity is expected to increase by about 64,000 samples per month.

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