On April 14, the Food and Drug Administration (FDA) issued emergency authorization for a new COVID-19 testing device developed by a Texas company. Known as the “InspectIR COVID-19 Breathalyzer,” it is the first diagnostic device that detects chemical compounds in the breath that are associated with COVID-19.
The device can give accurate results in 3 minutes and will only be available under the supervision of a licensed medical provider.
“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 accuracy of the InspectIR device has reportedly been proven by a research study and in peer-reviewed literature. The InspectIR device had a 91.2% success rate in identifying positive cases. Negative cases fared even better in the research studies, with a success rate of more than 99.3%.
The breath test device derives from technology initially designed to detect drugs and is currently approved for use in medical offices and hospitals. However, the future may see broader use of the InspectIR breathalyzers.
According to Yahoo News, the company behind the device, InspectIR LLC, believes it could play a role in keeping workplaces safe and healthy. Screening workers as they arrive onsite for work could limit widespread outbreaks in businesses.
The approval for the InspectIR device comes as medical experts are concerned about rising COVID-19 cases.
According to the Johns Hopkins Coronavirus Resource Center, April 14 saw 54,543 new COVID-19 cases in the U.S., most densely concentrated along the East Coast. New York had the highest number of new cases with 12,736.
“InspectIR expects to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day,” the FDA reports. “At this level of production, testing capacity using the InspectIR Covid-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.”
InspectIR LLC is based in Frisco, Texas.
