The First COVID-19 Breathalyzer Test Just Got FDA Approval

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COVID-19 testing has been developed quite a bit by researchers around the world. They have worked has to make COVID-19 testing more convenient and accessible each time. However, these tests have been restricted to nose, saliva, and throat samples. Until now!

Finding new ways to detect the virus has a huge impact on containment efforts, which is why it’s very exciting that the first COVID-19 breath test has been approved by the Food and Drug Administration (FDA) on April 14.

The Birth of an Innovative COVID-19 Test

This COVID-19 breath test has been designed as a screening tool to determine if a person might be affected in less than 3 minutes. That means it’s not meant to provide a confirmed diagnosis. So, if the breath test shows that the person is positive, the diagnosis would have to be confirmed with a PCR test.

Developed by InspectIR System, the breathalyzer test must be used by trained operators. What the test does is recognize 5 volatile organic compounds (VOCs) that are linked to the SARS-CoV-2 virus. This is accomplished by using the gas chromatography technique provided by a portable system, which analyzes the gases present in one’s breath, and a quadrupole mass spectrometer. 

Chemistry professor Guido Verbeck and his scientific team are responsible for the discovery of the SARS-CoV-2 breath print that gave way to the development of this breath-based test. They discovered it by comparing chemical profiles of breath samples from subjects with COVID-19 and subjects without the virus. 

The Basis for FDA Approval

The FDA based its approval on a study conducted by InspectIR System of over 2,400 people, some of whom were asymptomatic and some who weren’t. In the study, the breath-based test accomplished a specificity of 99.3 percent and a sensitivity of 91.2 percent compared to the PCR test. 

The FDA approved the use of the breathalyzer COVID-19 test for emergency use, but it advised against its use as the only basis for decisions concerning proper treatment.

During the study, the breath test delivered 17 false positives and 9 false positives, which is likely why it’s not used as a diagnostic test and why a PCR test is required if the breathalyzer comes out positive. 

It’s also worth noting that the study took place during the spread of the omicron variant, so InspectIR conducted a trial in February on 12 asymptomatic subjects to determine if there are any concerns about omicron detection. The results showed that there weren’t. 

How the COVID-19 Breathalyzer Works

The innovative device is the size of your average carry-on and it must be used by a trained operator while being supervised by a healthcare provider. The test is very simple; the patient only has to blow into the instrument’s straw, which is made of cardboard. 

The sample must be 0.25L, which is achieved in about 10 seconds. Once the breath is inside the machine, it interacts with the patented preconcentrator. This will gather and concentrate the 5 VOC targets. 

Once that happens, the VOCs will be exposed by the residual gas analyzer and the built-in algorithm will identify whether the mix points to COVID-19. After that, the software will notify the operator and let them know the results of the sample. If the sample is positive, a PCR test is required for confirmation.

Final Words

Now that InspectIR has FDA approval, they plan on producing 100 of these instruments per weak. Each of them can evaluate 160 samples per day, which according to the FDA, could increase testing capacity in the U.S. by as much as 64,000 monthly samples.

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