Dear USET/USET SPF Family,
On April 14, 2022, the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that can be performed using breath samples. The InspectIR COVID-19 Breathalyzer uses gas chromatography technology to identify certain compounds in exhaled breath that are associated with a SARS-CoV-2 infection. In a large study of almost 2,500 individuals, the InspectIR Breathalyzer performed extremely well: accurately detecting 91% of confirmed positive samples and 99% of confirmed negative samples. After a presumptive positive test result, InspectIR recommends that the result is confirmed with a molecular COVID-19 test, such as a PCR.
Like similar breathalyzer technology, COVID-19 testing by the InspectIR Breathalyzer can be performed simply by breathing into the diagnostic equipment, and analysis can be completed in less than three minutes. In addition to being much less invasive than other COVID-19 testing methods, this quick and convenient analysis will likely make this a great candidate for mobile testing sites. Currently, InspectIR is planning to produce about 100 instruments a week, each with a capacity of 160 samples per day, for a monthly testing capacity of approximately 64,00 samples. While the InspectIR Breathalyzers are not yet available for use, one estimate points to their release in about 10-12 weeks.
The USET TEC does not currently have specific information on when the InspectIR COVID-19 Breathalyzers will be available for purchase or distribution through the IHS, but will issue an updated alert as soon as that information is available to us. If you have any questions in the meantime, please do not hesitate to contact us at usetepi@usetinc.org.
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