US grants emergency use authorization for COVID-19 breath test

This method allows to detect chemical compounds in the breath, which appear when the body is infected with the SARS-CoV-2 virus.

“Testing can be performed in any environment such as clinics, hospitals and mobile testing sites, collecting and analyzing specimens at the same time, using an instrument the size of a piece of luggage. Addiction testing should be performed by a qualified, trained person, under the supervision of a health care provider authorized or authorized by law,” the FDA wrote in the announcement.

The FDA said that the department breath test for COVID-19 About the size of a carry-on suitcase, it can be used in clinics and mobile testing sites. This test kit can give results in less than 3 minutes.

This test method separates and identifies chemical mixtures to detect 5 chemical compounds related to the SARS-CoV-2 virus.

Many manufacturers have launched COVID-19 breathalyzers, but this is the first time the FDA has approved one. (Artwork: The Times of Israel)

The COVID-19 breath test has been shown to be effective in a large study of more than 2,000 participants, including people with the disease with and without symptoms. The meter gives results with a sensitivity of up to 91.2% (percentage of positive samples that the test correctly identifies) and a specificity of 99.3% (percentage of negative samples correctly identified).

A similar incidence was also observed in a study focusing on the Omicron variant. However, according to the FDA, a positive result still needs to be confirmed through a PCR test.

FDA assessment, this authorization represents breakthrough advances in the development of testing methods for the virus that causes COVID-19.

Machine maker VerifyIR expects to be able to produce about 100 devices per week, each of which can evaluate 160 samples per day, creating a testing capacity of 64,000 samples per month.

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