COVID Test Using Breath Samples Gets Green Light

FDA authorizes first-ever breath test for COVID-19

(RxWiki News) The US Food and Drug Administration (FDA) has authorized the first-ever diagnostic breath test for COVID-19.

This test offers a novel approach for COVID testing because it does not require a nasal swab or saliva sample, which have been the only ways to test for COVID-19 up until now.

Instead, this new test option can detect chemical compounds in breath samples that are associated with a SARS-CoV-2 infection.

Found under the name InspectIR COVID-19 Breathalyzer, this newly authorized test offers results in less than three minutes.

This test is to be used in environments where the sample can be collected and analyzed, such as doctors' offices, hospitals and mobile testing sites.

“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,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a press release.

The FDA gave this test emergency use authorization after it was studied in 2,409 individuals. This test population included people with and without COVID-19 symptoms.

If the breath test returns a positive result, health officials recommend getting a confirmation with a molecular test (PCR test), which is considered the gold standard.

On the flip side, if the COVID breath test result is negative, it is not the final say on infection status. Health care providers should still consider the patient's recent exposure to COVID-19, history, and signs and symptoms.

InspectIR said it plans to lease test devices to places that need the ability to do mass screening, which may include nursing homes, prisons, cruise lines and maybe even schools.

Speak to your health care provider if you have any questions.