First US Covid breath test authorized by FDA
Posted by  badge  on Apr 17
The company expects to be able to manufacture 100 of the breathalyzer machines a week (Picture: InspectIR Systems/Youtube)

Americans soon will be able to take a breathalyzer test to determine if they have Covid-19, the Food and Drug Administration announced Thursday.

The FDA granted emergency use authorization for the test, produced by InspectIR Systems, that uses breath samples to identify chemical compounds associated with the coronavirus.

The InspectIR Covid-19 Breathalyzer, which is about the size of a carry-on suitcase, can be used in doctor’s offices, hospitals or mobile testing sites. The test provides results in less than three minutes, according to the FDA.

A study done on the breathalyzer on 2,409 people both with and without symptoms of the virus found that it accurately identified over 91% of positive Covid samples and nearly 100% of negative samples. Similar results were seen in a follow-up study focused on the Omicron variant of the coronavirus.

The test detects chemicals associated with the virus that causes the disease in a breath sample. If the test is positive, it should be followed up by a molecular test, the FDA said in a .

‘Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,’ Dr Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

‘The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the U.S. for the next public health emergency.’

The announcement comes as the BA.2 Omicron subvariant has become the largest strand of the virus in the US, making up for about 86 percent of cases, according to the Centers for Disease Control and Prevention.

InspectIR says they should be able to produce about 100 testing instruments per week, according to the FDA. Each of the breathalyzer machines can be used to evaluate approximately 160 samples a day.

At this level of production, testing capacity is expected to increase by approximately 64,000 samples a month.


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