The Food and Drug Administration has issued an emergency use authorization for the first coronavirus diagnostic test that detects chemical compounds of the virus in a person’s breath.
The breath test, known as the InspectIR COVID-19 Breathalyzer, can be performed in doctor’s offices, hospitals, and mobile testing sites, using an instrument the size of carry-on luggage. The test should be administered by a trained health professional licensed by state law.
Results from the breath test can be reported three minutes after its administration.
“The authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeff Shuren, director of the agency’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 performance of the breath test was validated by a study of 2,409 people who had coronavirus symptoms and those who didn’t. The study showed 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).
Additionally, the test performed with similar sensitivity in a follow-up clinical study that dealt with the omicron variant. InspectIR wants to produce about 100 instruments per week, which translates to nearly 160 samples per day.