Lauren Dempsey, MS in Biomedicine and Law, RN, FISM News
Last week the FDA granted an emergency use authorization (EUA) for a breathalyzer test that can detect SARS-CoV-2 infections. This new test could help speed up the detection of COVID and provide a more comfortable test for children and those with sensitivities.
The diagnostic device, called InspectIR Covid-19 Breathalyzer, was initially developed as a potential roadside tool to screen for opioid or marijuana use, however, a study found that the InspectIR could also detect COVID-19 with almost 100% accuracy.
Normally a device would need to go through years- sometimes decades- of research, development, and testing prior to FDA approval, but with an EUA the FDA can grant authorization of unapproved products that could be lifesaving.
Dr. Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health praised the agency’s decision to authorize the new product in a statement saying this “is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19, especially as we are still in the midst of the COVID-19 pandemic, and this will help the U.S. prepare for future pandemics and public health threats. “
The test, which is about the size of a suitcase, can identify chemicals in an individual’s breath that are associated with a SARS-CoV-2 infection and can populate results within three minutes. The InspectIR breathalyzer uses a technique called gas chromatography-mass spectrometry (GC-MS) to separate and identify five volatile organic compounds. If these compounds are present, the test will provide a presumptive positive test. InspectIR recommends that a molecular test, like a PCR or antigen test, should be done in the case of a positive result.
The study included 2,409 participants, some of which displayed COVID-19 symptoms. The test was able to identify 91.2% of positive samples correctly and 99.3% of negative samples correctly, while only reporting 4.2% false negatives. The breathalyzer was shown to have similar results when tested with the Omicron variant.
Despite the positive results, the FDA cautioned that negative tests “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″ and that the breathalyzer test “should not be used as the sole basis for treatment or patient management decisions, including infection-control decisions” because it cannot definitively rule out infection.
The PCR test has been the gold standard of testing throughout the pandemic as they are the most sensitive diagnostic tool but has some limitations since it must be performed in a clinical setting and can be uncomfortable. Due to the sensitivity of the test, the CDC recommends that anyone who has had a recent COVID-19 infection be exempt from PCR testing for 90 days. This is because the test can detect fragments of the virus in the nasal passages long after a person is no longer infectious.
Dr. Emily Volk, president of the College of American Pathologists, a board-certified anatomic and clinical pathologist said, “It’s another tool, and the FDA announcement suggests it’s reasonably accurate and a relatively user-friendly tool.”
The company believes that it can produce about 100 breathalyzers each week, each of which can analyze about 160 samples a day. At this rate, they estimate that they could increase testing capacity by about 64,000 samples a month.