First COVID-19 test using breath samples authorized by U.S. FDA
CTV
The first COVID-19 diagnostic test, which identifies chemical components in breath samples unique to the coronavirus, received emergency use permission from the U.S. Food and Drug Administration (FDA) on Thursday.
According to the FDA, the test takes less than three minutes to get results and can be administered by a certified, trained operator under the supervision of a health-care physician who is licenced or permitted by state law to prescribe tests.
The test can be carried out at doctor's offices, hospitals, and mobile testing sites; where a patient’s samples can be both collected and analysed.
The InspectIR COVID-19 Breathalyzer is roughly the size of a carry-on bag and was used in an extensive study of 2,409 people, both with and without COVID-19 symptoms, to validate its performance.
The test was shown to have 91.2 per cent sensitivity (the per cent of positive samples accurately recognized by the test) and 99.3 per cent specificity in the research (the per cent of negative samples the test correctly identified).
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