The U.S. Food and Drug Administration issued an emergency use authorization for the first Covid-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection.
The test can be performed in hospitals, doctors’ office of mobile testing sites using an instrument about the size of a piece of carry-on luggage, and can provide results in less than three minutes.
“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,” said Jeff Shuren, Director of the FDA’s Center for Devices and Radiological Health.
The performance of the InspectIR Covid-19 Breathalyzer was validated after a study of 2,409 individuals. The FDA said that the test was shown to have 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). Also, the test performed “with similar sensitivity in a follow-up clinical study focused on the omicron variant”.
InspectIR expects to produce approximately 100 instruments per week and each be used to evaluate approximately 160 samples per day. At this level of production, testing capacity is expected to increase by approximately 64,000 samples per month.