If you have been looking forward to a new kind of COVID-19 test, one which doesn’t involve any sort of implement being scrubbed around inside your nasal passages, you can stop holding your breath. In mid-April, the Food and Drug Administration granted emergency use authorization (EUA) to the InspectIR COVID-19 breathalyzer test. But don’t toss those rapid antigen tests (RATs) just yet.
The initial utility of the breath test is limited. The breathalyzer machine itself is about the size of a piece of carry-on luggage and requires trained personnel to supervise its operation. Therefore, while it will be a welcome addition to the existing rapid diagnostic tests in health care settings and mobile test sites, it won’t be for home use.
Now that they have received FDA authorization, InspectIR Systems is expected to bring their COVID-19 breathalyzers to market in ~ 10-12 weeks and will produce 100 devices per week. Each device can run approximately 160 samples per day. In the company’s study of ~ 2,400 asymptomatic people, the breathalyzer correctly identified 91% of positive infections and 99% of negative infections (PCR was used as the gold standard).
The sample—a breath of air—is blown into a straw attached to an analyzer called a gas chromatograph-mass spectrometer (GC-MS). Within 3 minutes, the GC-MS can identify whether the breath contains a mixture of volatile organic compounds (VOCs) which are associated with SARS-CoV-2 infection. It’s important to note that certain foods and substances can affect the breath test; the testing instructions specify to avoid eating, drinking, and tobacco products in the 15 minutes prior to taking the test. The FDA recommends positive breath tests be confirmed with a molecular test.
No doubt more breath tests are on the way to development and approval. It remains to be seen how they will change the COVID-19 testing landscape.