FDA Authorizes COVID-19 Breathalyzer Test

4/14/22 — The FDA issued an emergency use authorization (EUA) to InspectIR Systems for their InspectIR COVID-19 Breathalyzer test. This is the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with SARS-CoV-2 infection. The test is authorized for people ages 18 and older without symptoms. It must be performed by a qualified, trained operator in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals, and mobile testing sites, using an instrument about the size of a piece of carry-on luggage.

Positive test results should be confirmed with a molecular test. Negative results do not rule out SARS-CoV-2 infection. Healthcare providers should consider negative test results along with a patient’s recent exposures, history, and presence of other clinical signs and symptoms consistent with COVID-19 and should perform follow up testing if necessary for patient management.

Read the FDA announcement.