Meet the InspectIR COVID-19 Breathalyzer test just authorized by the FDA

The first breath-based test for COVID-19 was approved by the Food and Drug Administration.

The InspectIR COVID-19 Breathalyzer can give highly accurate test results in about three minutes, without the need for a collection of hazardous samples. You can huff into as you head out the door, but it is not convenient. The test requires a high-tech device about the size of a carry-on suitcase, and it requires a trained technician to operate. A person has to blow into a traveling instrument with a straw for about 10 seconds to take the test.

GC-MS is a gold-standard analytical technique that can be used to separate out components of a mixture. GC-MS samples are mixed with a carrier gas and then go through a capillary column to separate out components. The components are further separated by their mass-to-charge ratios. Each peak on a gas chromatogram has a unique mass spectrum that allows for the identification of specific compounds.

For the COVID-19 breathalyzer test, InspectIR looks for the GC-MS signatures of five volatile organic compounds that are associated with a disease. The detection of these signatures is very accurate. According to the FDA, a study involving 2,409 people found that the device correctly identified 91 percent of known-positive samples as positive and 99 percent of known-negative samples as negative. The FDA noted that samples from people with and without COVID-19 symptoms were known-positive and performed in a follow-up study.

Exhalant results

In addition, the study showed that the test could be used to produce negative results in populations with low infections. In a population where only 4.2 percent of people were infectious, the test had a negative predictive value of 97 percent. The FDA cautions that negative results should be considered in the context of a patient's recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19.

The maker of the breathalyzer expects it to be able to perform around 160 tests per day in doctors' offices, hospitals, and mobile testing sites. There is no infectious or hazardous biological waste that needs to be cleaned or discarded after the device has been used. Test takers only need a single-use straw.

It isn't likely to be seen at every corner pharmacy any time soon. According to the FDA, InspectIR expects to be able to produce 100 instruments per week. It is unclear how much each test will cost.

The portable mini-GC-MS is an interesting and potentially more accurate way to test for COVID-19 than the current methods that are widely used.

Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement that the FDA's authorization on Thursday is yet another example of the rapid innovation occurring with diagnostic tests.