FDA approves EUA for breathalyzer tests for COVID-19

Photo: Monkhonkhamsao/Getty Images

Tests for COVID-19 have become all too common during the pandemic, and usually rely on a nasal swab to detect the presence of the SARS-CoV-2 virus, which causes the illness. The Food and Drug Administration however, has just granted emergency use authorization to the first-ever breathalyzer test for the virus, which can be used in doctor's offices, hospitals and mobile testing sites.

It's unlikely that a consumer would be able to use the device themselves, at least initially. Its application will be in clinical settings, where trained operators will conduct the test using an instrument about the size of a piece of carry-on luggage.

The test, dubbed the InspectIR COVID-19 Breathalyzer, is performed under the supervision of a healthcare provider licensed or authorized by state law to prescribe tests and can provide results in less than three minutes, according to the FDA.

WHAT'S THE IMPACT

The performance of the product was validated in a study of 2,409 people, including those with and without symptoms. In the study, the test was shown to have 91.2% sensitivity (the percent of positive samples the test correctly identified) and 99.3% specificity (the percent of negative samples the test correctly identified).

The study also showed that, in a population with only 4.2% of individuals who are positive for the virus, the test had a negative predictive value of 99.6%, meaning that people who receive a negative test result are likely truly negative in areas of low disease prevalence.

The test performed with similar sensitivity in a follow-up clinical study focused on the Omicron variant.

A technique called gas chromatography gas mass-spectrometry (GC-MS) is used to separate and identify chemical mixtures, and rapidly detect five Volatile Organic Compounds (VOCs) associated with SARS-CoV-2 infection in exhaled breath. When the breathalyzer detects the presence of VOC markers, a presumptive, unconfirmed positive test result is returned and should be confirmed with a molecular 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, as they do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions," according to the FDA.

InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate about 160 samples per day. At this level of production, overall testing capacity is expected to increase by roughly 64,000 samples per month.

THE LARGER TREND

Testing has been considered one of the mail tools used in the fight against COVID-19. The Biden Administration has placed such a high priority on testing that in November the Department of Health and Human Services invested $650 million from the American Rescue Plan to strengthen manufacturing capacity for quick diagnostic testing through rapid point-of-care molecular tests.

Hospitals, urgent care centers, pharmacies and other community healthcare settings use rapid molecular tests to diagnose COVID-19, screen patients before surgery without unnecessary delays, identify people who may benefit from COVID-19 therapies and confirm at-home test results.

To support access to this type of diagnostic testing, HHS planned on using these funds to ramp up U.S. domestic manufacturing capacity. The idea is that by strengthening the ability to produce the tests within the U.S., the reliance on overseas imports will be reduced, allowing the country to sustain robust long-term manufacturing throughout this year.

Aside from the vaccination push, which the administration and scientific community believes is the best method of preventing the spread of COVID-19, fast and frequent testing for the virus is seen as an important mitigation measure and has long been a focus of the Biden White House.

In July 2021, for example, HHS said it would invest more than $1.6 billion from the American Rescue Plan to support testing and mitigation measures in "high-risk congregate settings." This is intended to prevent the spread of COVID-19 and detect and stem potential outbreaks.

Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com