The FDA has approved a new device that can detect a SARS-CoV-2 infection through a person’s breath with high accuracy. The COVID-19 Breathalyzer, developed by InspectIR, is a miniaturized gas chromatograph with mass spectrometry coupling that can deliver reliable test results in just a few minutes. The device detects five volatile organic compounds (VOCs) that infected individuals exhale, which are then separated and identified in the mass spectrometer. The COVID-19 Breathalyzer has been tested on 2,409 subjects, including infected individuals with and without symptoms, and achieved a high sensitivity of 91.2% and a high specificity of 99.3%.

While the COVID-19 Breathalyzer cannot directly detect the virus in the air, it can provide a faster and more accurate alternative to traditional rapid tests. The device is about the size of a suitcase and can be used in places where many people need to be tested quickly, such as airports, hospitals, and large events. The cost of the test is not yet known, but experts predict it will be around $10-12 per test in a subscription model. However, the production capacity of the manufacturer, InspectIR, is currently limited to 100 COVID-19 Breathalyzers per week.

In the event of a positive test result, a PRC test is still required to verify the results. The COVID-19 Breathalyzer has the potential to revolutionize the way we test for the virus, providing a faster and more accurate alternative to traditional rapid tests. The device’s high sensitivity and specificity make it a valuable tool in the fight against the pandemic, especially in situations where many people need to be tested quickly.

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