An emergency use authorization (EUA) was granted by the U.S. Food and Drug Administration (FDA) for a COVID-19 diagnostic tool that searches for chemical components in breath samples that are linked to SARS-CoV-2 infection.
How Does The Breathalyzer Work?
This new FDA-approved test employs gas chromatography gas mass-spectrometry (GC/MS) to discover compounds in our breath associated with SARS-CoV-2 illness.
GC/MS separates and detects chemical mixtures at the molecular level (the M.S. component). It's one of the greatest instruments for identifying sample compounds. When a combination is heated, the distinct constituents separate. Heated gases are pushed via a column with inert gas (such as helium).
Mass spectrometry is a trustworthy analytical detector. Once separated, chemicals move into the MS. Mass spectrometry names compounds based on analyte molecule mass.
Mass spectra of sample molecules are compared to a library of known spectra. GC/MS isolates and detects five volatile organic compounds (VOCs) in exhaled breath connected to SARS-CoV-2 illness.
High-vapor-pressure, low-water-solubility solids, and liquids release VOCs as gases. The five VOCs are aldehyde and ketone-based. If the test reveals SARS-CoV-2 VOC markers, it's positive and should be confirmed molecularly.
Several clinical studies have looked into the possible role and frequency of these types of compounds in COVID-19 patients. Similar studies of metabolites are also being done for other kinds of diagnostics, even outside of the field of infectious diseases.
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What Is The Accuracy?
In a group where just 4.2 percent of people tested positive for the virus, the research found that the test was 99.6 percent accurate in predicting someone did not have the virus. People who get a negative test result in locations with low illness rates are likely to be healthy. The study's findings are as follows:
- 91.2% sensitivity (The percent positive samples the test correctly identifies)
- 99.3% specificity (The percent negative samples the test correctly identifies)
Even though the data on sensitivity and specificity look good, there are still some things to keep in mind. Despite a negative test result, a patient's recent exposure, history, and the existence of clinical signs or symptoms that are compatible with COVID-19 do not rule out the possibility of an infection.
InspectIR COVID-19 Breathalyzer users should not eat, drink, or smoke anything for 15 minutes prior to blowing into the device to avoid false positives. On top of that, there are a number of things that might impair the test's accuracy since it is looking for minor changes in the volume of gas exhaled. As a result, InspectIR offers extensive documentation on how to administer the test.
Is This Available For Everyone?
Only those 18 and above are permitted to use the COVID-19 Breathalyzer. It was tested on 2409 people, some of whom had symptoms and others who did not. Roughly 100 devices a week will be produced, each capable of testing about 160 samples daily.
The testing kit is a suitcase-sized gadget that may be carried anywhere. It is appropriate for both short-term and long-term clinical settings.
The findings are made available to the patient and their family within three minutes after taking a breath sample of 0.25 liters. The total number of samples that may be tested each month should increase by 64,000 as a result of the use of this instrument.
Which Is Easier & More Efficient, Swabbing For COVID-19 Or Breathing It?
PCR-based testing has the drawback of allowing for human error at various stages of the procedure. It's essential to have multiple testing options since PCR-based procedures may result in false negatives, even though this seldom happens. Several factors to consider include sample quality, sample handling, and processing time.
