FDA Authorizes First COVID-19 Breathalyzer Test


InspectIR / YouTube

Key Takeaways

  • The FDA has authorized the first-ever breathalyzer test for COVID-19.
  • The test, which must be administered by a professional, can provide results in under three minutes.
  • While the test appears highly accurate against Omicron, the FDA says positive results should be confirmed with a PCR test.

For the first time, a breathalyzer can be used to help diagnose COVID-19. And it delivers results in less than three minutes.

The Food and Drug Administration (FDA) on Thursday granted emergency use authorization to the device, called the InspectIR COVID-19 Breathalyzer, for people 18 and older.

According to an FDA press release, the test works by detecting five volatile organic compounds (VOCs) associated with COVID-19 in exhaled breath, making it a much less invasive testing method than a nasal swab.

How Accurate Is It?

A study of 2,400 people with and without COVID-19 symptoms found that the breathalyzer correctly identified roughly 91% of positive cases. The test was able to correctly identify 99.3% of negative cases.

A follow-up study showed similar accuracy against the Omicron variant.

How Do Rapid Tests Compare?

The Abbott BinaxNOW rapid test has an overall 65% sensitivity against Omicron, though it can be as high as 95% if a person’s viral load is high enough—usually about three days after exposure.

InspectIR has not yet responded to Verywell about whether there is an ideal time after exposure or symptom onset to use its breathalyzer test.

Where Can You Take It?

There’s no at-home COVID-19 breathalyzer yet. The FDA said the test can be performed by a trained professional in doctor’s offices, hospitals, and mobile testing sites.

Eventually, InspectIR hopes its test can be used outside of a clinical setting, serving as an on-the-spot screening tool for COVID in places like offices.

“In less than three minutes, our device(s) can tell if a person may be actively infected and precluded from entrance/admission to a facility,” president and co-founder John A. Redmond said in a press release last June. “The only way to ensure a true safety protocol is to understand if people are well enough to be there right now.”

You May Need to Test Again 

Based on the current authorization, the InspectIR COVID-19 Breathalyzer is more of a screening tool than a diagnostic tool.

The FDA said a positive result should be confirmed with a molecular test, like a PCR test. In areas where COVID-19 levels are low, patients might be able to take a negative breathalyzer result at face value, though their symptoms and recent exposure should help inform whether or not they follow up with a molecular test.

What This Means For You

New COVID-19 breathalyzer tests will give you results faster than ever. But you’ll need to see a healthcare professional to take one, and you may need to confirm your results with a swab-based test.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.

1 Source
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  1. Schrom J, Marquez C, Pilarowski G, et al. Comparison of SARS-CoV-2 reverse transcriptase polymerase chain reaction and BinaxNOW rapid antigen tests at a community site during an Omicron surge: a cross-sectional study. Ann Intern Med. Published online March 15, 2022. doi:10.7326/M22-0202

By Anisa Arsenault
Anisa joined the company in 2018 after managing news surrounding fertility, pregnancy, and parenting for The Bump. Her health and wellness articles have appeared in outlets like Prevention and Metro US. At Verywell, she is responsible for the news program, which includes coverage of COVID-19.