FDA Approves First Breath Test for COVID-19
The test, which must be administered by a trained operator, demonstrates a high degree of accuracy
FRIDAY, April 15, 2022 (HealthDay News) -- People who suspect they may have COVID-19 could soon find out with a simple breath test that delivers results in three minutes.
On Thursday, the U.S. Food and Drug Administration granted an emergency use authorization for a device called the InspectIR Covid-19 Breathalyzer. The test, which must be administered by a trained operator, demonstrates a high degree of accuracy while taking up no more space than a piece of carry-on luggage.
"Today's authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19," Jeff Shuren, M.D., director of the FDA Center for Devices and Radiological Health, said in an agency news release announcing the approval. "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."
InspectIR can run 160 samples per day and may be used at mobile testing sites, hospitals, and doctors' offices. The company can produce about 100 of the machines a week. The test uses gas chromatography gas mass-spectrometry, a technique that separates and identifies chemical mixtures, to spot the presence of five compounds associated with COVID-19.
Its accuracy was confirmed in a large study of just over 2,400 people, including those with and without symptoms. In the end, the test was shown to have 91.2 percent sensitivity and 99.3 percent specificity. The test performed just as well in a follow-up study focused on the omicron variant.
A positive test should be confirmed through another testing method, such as a polymerase chain reaction lab test, the FDA stressed. The agency warned that negative tests "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" and "should not be used as the sole basis for treatment or patient management decisions, including infection control decisions."