FDA authorizes emergency use of first Covid-19 Breathalyzer

(Eagle News) The U.S. Food and Drug Administration issued today an emergency use authorization for the first ever test that detects breath samples for Covid-19.

According to a statement released by the FDA, the diagnostic test would detect chemical compounds in the breath associated with a SARS-CoV-2 infection.

The samples are analyzed with an instrument about the size of a carry-on luggage and the collection of the sample as well as the analysis can be done in doctor’s offices, hospitals and mobile testings sites.

“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeff Shuren, M.D., J.D., director of the FDA’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 FDA said the InspectIR COVID-19 Breathalyzer was validated in a large study of 2,409 individuals, including those with and without symptoms.

“In the study, 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),” said the FDA release.

The estimated 100 instruments per week expected to be produced can be used to evaluate approximately 160 samples a day or 64,000 samples per month.z

(Eagle News Service)