© InspectIR Systems
A new testing pathway for COVID-19 was opened last week, with Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA) for the InspectIR COVID-19 breathalyzer. 19, a diagnostic capable of detecting SARS-CoV-2 infection from breath samples.
In less than three minutes, the InspectIR test has proven capable of providing results in medical offices, hospitals, and mobile testing sites. However, it is not self-executing: it must be issued by a trained operator under the supervision of a licensed/authorized healthcare provider. Yet in a study of 2,409 participants with and without symptoms, the test offered a sensitivity of 91.2% – or the percentage of correctly identified positive samples – and a specificity of 99.3% – the percentage of negative samples. correctly identified.
It also worked the same on the omicron variant as it did on the original strain.
“Today’s clearance is another example of the rapid innovation happening 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 new COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the United States for the next public health emergency.”
InspectIR is expected to produce approximately 100 breathalyzers per week, each capable of evaluating approximately 160 samples per day. This means the company could increase its testing capacity by around 64,000 samples per month.
The test works by gas chromatography-mass spectrometry (GC-MS) to separate and identify chemical mixtures and quickly detect certain compounds associated with SARS-CoV-2 infection in each exhaled breath. Once detected, the test provides a presumptive positive result, and users are encouraged to confirm with molecular testing.