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Home / Health Conditions / COVID-19 / FDA Has Now Approved A Breathalyzer Test For COVID-19

FDA Has Now Approved A Breathalyzer Test For COVID-19

breathalyzer test
The InspectIR’s COVID-19 breathalyzer test in action. (Photo by InspectIR)

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.

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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.

RELATED: As Cases Rise, Here’s How to Protect Yourself From COVID BA.5

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:

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  • 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,

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