The New COVID-19 Breath Test: Potential Uses, Limitations, and More

If you’ve ever been tested for COVID-19, you know how unpleasant the experience can be. For many people, the 30 seconds of nasal swabbing can’t go by fast enough. But what if you could skip the swabs altogether? And what if the process could be as simple as breathing?

Key takeaways:

• The FDA has authorized the first COVID-19 test that uses breath samples. It can be used by adults with or without symptoms of COVID-19.
• Instead of detecting the virus, the breath test looks for chemical compounds released by the body in response to infection by SARS-CoV-2, the virus that causes COVID-19.
• It takes less than 3 minutes to get results. But the testing instrument can only process one sample at a time (20 per hour). This might limit its use for wide scale testing.

The idea of using breath samples to detect medical conditions isn’t new. In fact, it’s been researched for a variety of respiratory infections and other conditions. That’s because certain germs have distinct chemical “signatures” that show up in your breath. The same appears to be true for SARS-CoV-2, the virus that causes COVID-19.

Last month, the FDA authorized the InspectIR COVID-19 Breathalyzer, the first COVID-19 test that uses breath samples. It can be used in adults with or without symptoms of COVID-19. With so many COVID-19 tests on the market, where does a breath test fit in? Keep reading to learn more.

How does the new COVID-19 breath test work?

The InspectIR COVID-19 Breathalyzer works by detecting five different volatile organic compounds (VOCs) in a breath sample. These VOCs are released by the body in response to a SARS-CoV-2 infection.

How are breath samples taken?

A trained healthcare professional will have you blow into a single-use straw that’s inserted into the testing instrument. You’ll typically need to blow for 10 seconds or less to provide an adequate sample. If necessary, the sample may be collected in more than one exhaled breath.

It’s important not to eat, drink, or smoke within 15 minutes of taking the test. This might affect your results.

How long does it take to get results?

Since you’re breathing directly into the testing instrument, no additional steps are needed for handling the sample. The instrument uses gas chromatography-mass spectrometry (GC-MS) to identify any VOCs in your breath. This process takes less than 3 minutes to complete.

You’ll get a positive result if the VOCs are found in your sample. Likewise, you’ll get a negative result if they’re not detected.

How accurate is the COVID-19 breath test?

According to the FDA announcement, this COVID-19 breath test was able to identify about 99% of negative samples correctly. This means there’s a low chance of a false positive result. A false positive is when you test positive, but you’re not actually infected.

The test was also able to identify about 91% of positive samples correctly. So, there may be a slightly higher chance of getting a false negative result. A false negative is when you test negative, but you actually have the virus. But in areas of low COVID-19 prevalence, most negative results are likely to be truly negative.

Remember: Symptoms and exposure to the virus should also be taken into account when you’re reviewing your results. If you test positive, you should confirm your result with a molecular test.

How does the COVID-19 breath test compare to other tests?

There are several different COVID-19 testing options available today. And it can be difficult keeping them all straight. For example, some require a prescription, while others can be purchased over-the-counter (OTC). In some cases, you’re able to collect your own sample at home or even perform the test yourself.

So, how does the COVID-19 breath test stack up to current testing options? We’ve highlighted a few notable differences below.

Keep in mind that each type of COVID-19 test has its place. For example, molecular tests are able to detect very small amounts of virus in a sample. They’re useful in helping to diagnose COVID-19 sooner and confirming results from other faster, but less accurate, tests. But they can also still show a positive result for a longer time after infection.

Antigen tests aren’t as sensitive as molecular tests. They likely won’t detect small amounts of virus that hang around after you’ve recovered. So, they’re the preferred option if you’re testing to leave isolation if you had COVID-19.

How would the COVID-19 breath test be used?

So where does the breath test fit in? InspectIR, the company that makes the test, anticipates that it could be useful for screening purposes. Screening is when you test people without symptoms for early detection. For example, you could quickly test many people attending a large event, school, or workplace.

However, the InspectIR COVID-19 Breathalyzer has a few limitations. First, the testing instrument is about the size of a small suitcase and needs to be operated by a trained healthcare professional.

And although it’s fast, it can only test one sample at a time. That means each instrument can process up to 20 samples per hour and 160 samples per day. In this case, many instruments may be needed to have enough testing capacity, depending on how it’s used. At least for now, it may be difficult to use the breath test for wide scale testing efforts.

Where is the COVID-19 breath test available?

InspectIR is currently ramping up test production. They expect to have 250 testing instruments ready within the next month. From there, they plan to make about 100 more every week. As mentioned above, each one can process about 160 samples every day.

So, these tests may not be widely available for a while. But you’ll likely find them at mobile testing sites, hospitals, and medical offices if or when they are available. InspectIR plans to lease the testing instruments to facilities for a monthly fee. Based on the fee, they expect the cost per test to be around $10 to $12.

The bottom line

The InspectIR COVID-19 Breathalyzer is the first COVID-19 test that uses breath samples. It’s the fastest of all the COVID-19 tests, producing results in less than 3 minutes. Based on clinical study results, there appears to be a low chance of getting a false positive result with this test.

It’s still early to see how this breath test will fit into COVID-19 testing strategies. It could be useful to help screen people before events, school, or work. But there are a few limitations that might restrict how widely it’s used.

References

Belizario, J. E., et al. (2021). Breath biopsy and discovery of exclusive volatile organic compounds for diagnosis of infectious diseases. Frontiers in Cellular and Infection Microbiology.

Centers for Disease Control and Prevention. (2022). Overview of testing for SARS-CoV-2, the virus that causes COVID-19.

Centers for Disease Control and Prevention. (2022). Quarantine and isolation.

Food and Drug Administration. (2022). Coronavirus (COVID-19) update: FDA authorizes first COVID-19 diagnostic test using breath samples.

Food and Drug Administration. (2022). InspectIR COVID-19 breathalyzer (for use on PNY-1000).

Lucira Health. (n.d.). COVID-19 PCR quality at-home test.

Pezenik, S. (2022). FDA authorizes 1st COVID-19 ‘breathalyzer’ test. ABC News.

United States Postal Service. (n.d.). Place your order for free at-home COVID-19 tests.

Written by Alyssa Billingsley, PharmD | Reviewed by Joshua Murdock, PharmD | Photo by Gustavo Fring from Pexels

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