The company’s maker InspectIR (Frisco, Texas) expects to manufacture roughly 100 instruments per week, the FDA said in an announcement posted yesterday. The devices can each evaluate roughly 160 samples per day. Someone taking the test — under supervision at a doctor’s office, hospital or testing site — can receive a result in less than three minutes.
“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Dr. Jeff Shuren, 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 granted the emergency use authorization after a study involving 2,409 people, including those with and without symptoms. The study found the test had 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).
The InspectIR COVID-19 Breathalyzer uses gas chromatography gas mass-spectrometry to separate and identify chemical mixtures. It can rapidly detect five volatile organic compounds associated with SARS-CoV-2 infection in exhaled breath.