- Food and Drug Administration has authorized the first COVID-19 diagnostic test that detects the virus in exhalation samples. InspectIR Systems’ COVID-19 Breathalyzer delivers results within three minutes.
- The test, designed for use by trained operators, detects five volatile organic compounds (VOCs) associated with SARS-CoV-2 infection using a portable gas chromatography system and a quadrupole mass spectrometer. The FDA expects the test to be run at doctors’ offices, hospitals and mobile test sites.
- IN a multi-site study of more than 2,000 asymptomatic individuals, the test achieved a sensitivity of 91.2% and specificity of 99.3% versus polymerase chain reaction (PCR)which led to the FDA granting an emergency use permit, but advises against using the breathalyzer as the sole basis for treatment decisions.
Researchers around the world began to take a closer look the potential to detect COVID-19 in respiration in the early weeks of the pandemic, leading to more authorizations in overseas territories. However, testing in the United States has remained limited to nose, throat and saliva samples. That changed late last week when the FDA granted an EUA to InspectIR.
The authorization includes an instrument the size of a piece of hand luggage. Under the supervision of a healthcare provider, a trained operator asks the person being tested to blow into a vacuum cleaner tube inserted into the side of the instrument. The individual should give a sample of 0.25 liters of exhaled breath, something most people will do in 10 seconds or less.
Inside the instrument, the exhalation sample interacts with InspectIR’s patented preconcentrator to collect and concentrate specific VOC targets.
The five VOCs that are in the ketone and aldehyde families are associated with the coronavirus infection. Once concentrated, VOCs are detected by a residual gas analyzer and an algorithm determines if the mixture is indicative of COVID-19. The software then tells the operator whether the sample is negative or presumably positive. All this happens in less than three minutes.
However, the “presumed positive” formulation points to a limitation of the test. People who test positive should take a molecular test such as a PCR to confirm if they are infected. Similarly, FDA advises healthcare professionals to consider adverse outcomes in light of “a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19.”
InspectIR generated data in support of EUA in a study of 2,409 asymptomatic individuals. PCR tests showed that 102 people were COVID-19 positive. The InspectIR test yielded nine false negatives and 17 false positives. When the study took place before the spread of omicron, InspectIR ran a trial in February to evaluate the test in 12 symptomatic subjects. The experiment found no concerns about the detection of omicron.
After securing the EUA, InspectIR plans to make about 100 instruments a week. Since each instrument can be used to evaluate about 160 samples a day, the FDA estimated that the EUA could increase US testing capacity by about 64,000 samples a month.