FDA approves first breath test for the coronavirus

The Food and Drug Administration has authorized the first test that can detect the coronavirus in a person’s breath.

The InspectIR COVID-19 Breathalyzer uses technology that can detect chemical compounds from the virus in a breath sample.

Regulators said the device is the size of a piece of carry-on luggage and will likely be ideal for screening in doctor’s offices, hospitals and mobile testing sites. It received an emergency use authorization under a process that expedites the review of drugs and devices in a crisis.

“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “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 test is a notable advancement because of the ease of submitting a breath test compared to nasal swabs that have been panned as awkward or invasive.

However, the tests will take time to produce and the FDA said a positive test should be confirmed by a molecular test.

The FDA said the device was validated in a study of 2,409 people, including those with and without symptoms. It had a 91.2% sensitivity, meaning the percentage of positive samples that are correctly identified, and 99.3% specificity, or the percentage of negative samples that are correctly identified.

The FDA said InspectIR expects to produce about 100 of its instruments per week.

Each device can be used to evaluate approximately 160 samples per day, meaning the breathalyzer will increase overall testing capacity by approximately 64,000 samples per month.

For more information, visit The Washington Times COVID-19 resource page.