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First Covid-19 breath test approved by FDA

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eMediNexus    15 April 2022

The first Covid-19 breath test, the InspectIR Covid-19 Breathalyzer, received emergency use authorization from the US Food and Drug Administration. 

The Breathalyzer detects chemical components linked to the coronavirus in breath and was of roughly the size of a carry-on suitcase, which could be easily used in medical offices and mobile testing sites and provides results within three minutes. It detects five chemicals linked to SARS-CoV-2 infection by separating and identifying chemical combinations.

The accuracy was proved from the data which shows it correctly recognized more than 91% of positive samples and nearly 100% of negative samples in a trial. Similar sensitivity was observed in another study which death with the Omicron. According to the FDA, a positive result from the breath test should be validated with a PCR test. (Source: CNN, April 14, 2022)

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