The Food and Drug Administration on Thursday announced the approval of the first breath-based test for COVID-19.
InspectIR COVID-19 Breathalyzer provides very accurate test results in approximately three minutes without the need for unpleasant inoculation or collection of hazardous samples. But before you start hoping for a handheld device that you can pull in when you walk out the door, it’s not that practical. The test requires a high-tech device the size of a carry-on suitcase – demo versions are literally housed in hard-to-roll hardboard cases – and require a trained technician to operate. To take the test, a person should sit next to that travel instrument and blow into it through a straw for about 10 seconds.
The instrument inside the baggage actually performs gas chromatography-mass spectrometry (GC-MS), which is a gold standard analytical technique for finely separating the components of a mixture. Generally, GC-MS samples are evaporated and mixed with an inert carrier gas before passing through a capillary column which separates components at their boiling point and polarity. These components are then ionized and fragmented and further separated by their mass-to-charge ratio. The final readings are different peaks on a gas chromatogram, where each peak has a unique mass spectrum, which allows for unique identification of specific compounds.
For the COVID-19 breathalyzer test, InspectIR looks for the GC-MS signatures of five volatile organic compounds associated with a SARS-CoV-2 infection. The detection of these signatures has proven to be 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 (test sensitivity) and correctly identified 99 percent of known negative samples as negative (test specificity). The FDA also noted that known positive samples came from individuals with and without COVID-19 symptoms and performed equally well in a follow-up study involving the omicron variant.
In addition, the study showed that the test could give reliable negative results in populations where the infection rate is low. That is, in a population where only 4.2 percent of people were infected, the test had a negative predictive value of nearly 97 percent. Although the FDA warns that “adverse outcomes 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, as they do not exclude SARS-CoV-2 infection and should not used as the sole basis for treatment or patient management decisions, including infection control decisions. “
The test maker, InspectIR Systems LLC, a Texas-based unit company, expects the breathalyzer to run into doctors’ offices, hospitals and mobile test sites, where each instrument can perform about 160 tests a day. Because it heats and ionizes each breath sample, there is no infectious or hazardous biological waste that requires cleaning or disposal afterwards. Test takers only need a single-use hygienic straw for sample submission.
But it is unlikely that it will appear in every corner pharmacy soon. InspectIR expects to be able to produce only about 100 instruments a week, the FDA notes. It is also unclear how expensive each test will be in different locations.
Still, the portable mini-GC-MS is an interesting – and potentially more accurate – rapid test for COVID-19 than the currently widely used antigen-based methods.
The FDA’s approval on Thursday “is another example of the rapid innovation happening with diagnostic tests for COVID-19,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement. “The FDA continues to support the development of new COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the United States for the next public health emergency.”