The Food and Drug Administration issued the first breath test device to detect COVID-19 infection. The InspectIR COVID-19 Breathalyzer can be used in doctor’s offices, hospitals and mobile testing sites due to its small size.
InspectIR COVID-19 Breathalyzer utilizes a technique called gas chromatography gas mass spectrometry (GC-MS) to separate and identify chemical combinations and quickly detect five volatile organic compounds (VOCs) associated with SARS-CoV-2 infection in exhaled breath.
The agency said, “InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day”. It further added that with this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by 64,000 samples per month.
According to FDA, the test can provide the result in less than three minutes. However, the test should be provided under the supervision of a licenced care provider.
The director of the FDA’s Centre for Devices and Radiological Health Dr Jeff Shuren said the device is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19. On April 14, the FDA announced, “the device is identified 91.2% of positive test samples correctly and 99.3% of negative test samples correctly”.