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USA: The FDA approved the first breath test to detect coronavirus

The US Food and Drug Administration (FDA) has issued an emergency license for the “Covid-19 breathalyzer” from InspectIR Systems, the first approved device capable of detecting coronavirus infections in patients’ breath, according to Forbes.

The device correctly recognized 91.2% of the positive samples in a study of 2,409 people and also performed well in a later study that evaluated its effectiveness against the Omicron mutation, according to an FDA announcement.

The breath test provides results in less than three minutes and can be administered to either health care facilities or mobile coronavirus test units using an instrument about the size of a hand luggage, the agency said.

InspectIR predicts it will eventually be able to produce about 100 Covid-19 breath tests a week, each of which will be able to perform about 160 tests a day, the FDA said.

With InspectIR’s current production levels, it will boost U.S. control capacity by about 64,000 samples each month, the agency said.

Source: Capital

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