The FDA on April 14 issued the first emergency use authorization for a COVID-19 diagnostic test that can detect the coronavirus in breath samples within three minutes.
The InspectIR COVID-19 Breathalyzer test can be performed by trained operators in physicians' offices, hospitals and mobile testing sites, according to an FDA news release. It uses a technique called chromatography gas mass-spectrometry to separate and identify chemical mixtures to quickly detect five compounds associated with a COVID-19 infection in exhaled breath. The device used to analyze results is about the size of a piece of carry-on luggage and can analyze about 160 samples per day.
The test's performance was validated in a study of 2,409 people with and without symptoms. It displayed a 91.2 percent sensitivity, reflecting the percent of positive samples the test correctly identified, and 99.3 percent specificity, the percent of negative samples the test correctly identified.
InspectIR said it expects to produce 100 machines per week.