The US FDA Approved First Breathalyzer to Detect COVID-19
Shots:
- The US FDA has granted EUA for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection and can deliver results within 3min
- The approval was based on the study of 2,409 individuals, including those with and without symptoms. The test showed 91.2% sensitivity and 99.3% specificity. The test performed with similar sensitivity in a follow-up clinical study focused on the omicron variant
- InspectIR expects to make ~100 instruments/week, each of which can be used to evaluate around 160 samples/day. At that production rate, testing capacity using the breathalyzer is estimated to increase by ~64K samples/mos.
Ref: The US FDA | Image: The US FDA
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