Page Text: There's Now a Breath Test for COVID-19. Here's How the Inspectir Breathalyzer Works
The Food and Drug Administration has authorized InspectIR's test kit, which returns results in under 3 minutes.
Dan Avery
April 15, 2022 1:02 p.m. PT
Dan Avery
Writer
Dan is a writer on CNET's How-To team. His byline has appeared in Newsweek, NBC News, The New York Times, Architectural Digest, The Daily Mail and elsewhere. He is a crossword junkie and is interested in the intersection of tech and marginalized communities.
InspectIR's COVID-19 Breathalyzer test kit is about the size of a piece of carry-on luggage.
InspectIR
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The US Food and Drug Administration has authorized emergency use of a COVID-19 diagnostic test that uses your breath, rather than a nasal swab, to detect the virus. About the size of a piece of carry-on luggage, the InspectIR COVID-19 Breathalyzer test kit looks for several chemical compounds found in the exhalations of people with the virus.
InspectIR is promoting the test as both less invasive and faster than PCR or even rapid antigen tests, making it potentially useful for public settings like offices, restaurants and airports.
Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, called the device "another example of the rapid innovation occurring with diagnostic tests for COVID-19."
How does the breath test work?
The Breathalyzer uses a technique called gas chromatography-mass spectrometry (GC-MS) to separate and identify chemical mixtures and rapidly detect five volatile organic compounds in exhaled breath associated with SARS-CoV-2 infection.
Breath tests are used to rule out COVID in as many cases as possible in larger public settings. If the InspectIR COVID-19 Breathalyzer detects the presence of these markers, it delivers an unconfirmed positive test which InspectIR says should be confirmed with a PCR or antigen test.
"Negative results should be considered in the context of a patient's recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19," the company said.
How long does it take to deliver results?
According to InspectIR, results from the breath test are available in less than three minutes.
That's compared with two to three days for a PCR test at a testing site, an hour or so for a rapid PCR test and 15 to 30 minutes for rapid antigen tests.
InspectIR has characterized its breath test as a better screening method than taking a person's temperature when it comes to workers returning to the office. And the company says other types of COVID diagnostic tests are uncomfortable and costly when repeated daily.
InspectIR's Breathalyzer device can deliver COVID-19 test results in under three minutes, the company says.
InspectIR
How does its accuracy compare to PCR and rapid antigen tests?
According to the FDA, the InspectIR COVID-19 Breathalyzer has been shown to have 91.2% sensitivity in identifying positive virus results, and 99.3% accuracy with negative results. It presented false negatives 4.2% of the time.
PCR tests are the most sensitive diagnostics, able to detect even minute traces of SARS-CoV-2 with an accuracy rate of nearly 100% . But they're expensive and must be performed in a clinical setting.
Rapid antigen tests, the kind available at supermarkets and pharmacies, and that are being given out free by the government , are less sensitive than either. One brand of rapid test, for example, correctly returned a positive result 83.5% of the time, according to information on the FDA's site. That test correctly diagnosed a negative result 99.2% of the time. Rapid antigen tests can also result in a false negative if you're tested early in your infection cycle.
Various studies have determined that antigen tests are more accurate in people with high viral loads and who are presenting symptoms.
Where will the breath test be sued?
The Breathalyzer is portable but the test must still be administered by a trained technician, making it more suitable for hospitals, doctor's offices and larger public spaces, rather than for homes or small businesses.
InspectIR has said it expects to produce approximately 100 Breathalyzers a week, which can each be used to evaluate about 160 samples per day.
"At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month," the FDA reported.
Are other companies working on breath tests for COVID-19?
To date, only InspectIR has received FDA approval for use in the US. But numerous companies have been working on breath tests, including Singapore's Breathonix, the UK's Owlstone Medical, Indonesia's GeNose C19 and Israel's Scentech Medical.
In February 2021, SpiroNose became the first breathalyzer approved to test for COVID in the real world. It was used to screen workers at last year's Eurovision Song Contest in Rotterdam.
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