Before COVID-19, I don’t remember reading about the U.S. Food and Drug Administration’s (FDA) emergency use authorization (EUA). After the nearly two and half years of pandemic response, EUA is now common parlance in the health tech industry. The FDA granted EUA hurry-up approvals to personal protective device (PPD) masks and vaccines in order to speed access. EUA status doesn’t indicate FDA scrutiny is over; full FDA clearance still requires the FDA’s regular testing protocols and approvals. On April 14, 2022, the FDA issued an EUA for Inspect-IR’s portable COVID-19 diagnostic screening device.
Inspect-IR’s methodology is a miniature mass spectrometer that analyzes breath samples directly. Unlike other current testing, the InspectIR technology doesn’t store biologic material to check cross reactivity. There’s also minimal waiting time for results. After a subject exhales by mouth through a tube into the Inspect-IR COVID-19 Breathalyzer, the device captures and measures the chemistry in the breath, identifies and quantifies existing COVID-19 markers and spectrometry, and finally analyzes and displays the results. The entire process takes approximately three minutes.
Inspect-IR tested the system in multiple clinical trials. The FDA EUA validation test was a large study of 2,409 persons with and without COVID-19 symptoms. The tests results showed 91.2% sensitivity (true positives) and 99.3% specificity (true negatives). A follow-up clinical study that focused on the COVID-19 omicron variant had similar results.
The Inspect-IR COVID-19 Breathalyzer identifies chemical mixtures using gas chromatography gas mass-spectrometry (GC-MS). This process separates and identifies volatile organic compounds (VOCs). The test screens for five VOCs associated with SARS-CoV-2 infection. You may recall hearing about mass spectrometry from frequent references to a large machine used by the character Abby Sciutto in a forensic lab in the television series NCIS.
The Inspect-IR won’t make a significant difference in COVID-19 detection anytime soon. The device isn’t portable in the sense that you could put one in your vehicle, drive to a new location, set it up quickly and begin testing. The device is approximately the size of carry-on luggage. The test can only be administered by qualified, trained operators supervised by a licensed health care provider. Each machine can evaluate about 160 samples per day and Inspect-IR plans to produce about 100 devices each week.
Jeff Shuren, director the FDA’s Center for Devices and Radiological Health indicated the greater potential to make a difference during future pandemics. “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,” Shuren said in a news release about EUA issuance for the the Inspect-IR. If we can get smaller, more mobile, low-cost devices that can analyze breath for COVID infections, it could make screening for this (and possibly future) disease more broadly available.
