A breath-based COVID-19 test was given Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) on Thursday.
The breathalyzer style test was manufactured by InspectIR Systems, taking breath samples from a patient and delivering results in as little as 3 minutes, from start to finish.
“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health said. “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 InspectIR PNY-1000 test is non-invasive and requires a patient to blow into a single-use sanitary straw for about 10 seconds. The breath is then analyzed by the machine, looking for “specific chemistry associated with COVID-19” and displaying immediate results, with similar accuracy as a PCR test, according to InspectIR.
The machine itself is about the size of carry-on luggage and is considered mobile. The technology for the test works with a process of “gas chromatography gas mass-spectrometry (GC-MS)” which identifies chemical mixtures and looks for five “Volatile Organic Compounds (VOCs)” that are consistent with COVID-19 and often found in the breath of infected patients.
With the EUA, InspectIR expects to make at least 100 devices per week and may soon be found in doctor’s offices, hospitals and mobile COVID-19 testing sites.
It is expected that each machine can produce 160 daily tests for an eventual 64,000 tests per month.
In a study of 2,409 individuals, with and without COVID-19 symptoms, the InspectIR test produced correctly identified 91.2% of positive COVID-19 samples and 99.3% of negative COVID-19 samples.