First COVID-19 Breath Test Gets FDA Authorization

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to the world’s first COVID-19 breath test.

The InspectIR COVID-19 Breathalyzer is a portable, non-invasive test developed by InspectIR Systems that can detect the presence of chemical compounds in the breath produced by the body when it is fighting a COVID-19 infection.

The device produces results in three minutes and is being touted to be more accurate than rapid antigen tests, which have an accuracy of around 60 percent, according to some experts.

According to the FDA, a recent study demonstrated that the InspectIR COVID-19 Breathalyzer has a high sensitivity as it was able to accurately identify just over 91 percent of positive COVID samples. It also had high specificity as it correctly identified 99.3 percent of negative samples, which means the false negative rate is less than one percent.

The COVID-19 breath test can be administered in any setting equipped to collect and analyze samples using the test instrument, such as hospitals, mobile testing sites and doctor’s offices. This COVID-19 breathalyzer is the size of a piece of carry-on luggage.

InspectIR Systems is a research, development and device company focused on developing technologies to deliver accurate breath test results in real-time.

Related: Menarini Diagnostics’ New COVID-19 Test Detects Variants Including Omicron

InspectIR’s COVID-19 mobile screening solution is based on the company’s patented breathalyzer technology.

Users provide breath samples by blowing about a quarter of a liter of air (the volume roughly of a small balloon) into a single-use, straw-like tube inserted into the machine. It takes about ten seconds for subjects to provide a viable sample, after which the machine begins the measurement and analysis processes, generating results within just a couple of minutes.

The COVID-19 breath test is designed to detect the presence of five volatile organic compounds (VOCs) associated with SARS-CoV-2 infection in exhaled breath using gas chromatography mass spectrometry (GC-MS). InspectIR Systems says the device is a “chemical-lab-in-a-box” and essentially a “miniature” mass spectrometer used for the direct analysis of breath samples.

The test administrator has minimal contact with the unit because there is a wireless keyboard and a touch screen that can be easily sanitized.

The FDA says if the device produces a positive result, based on the presence of the SARS-CoV-2 VOC markers, it should be confirmed with a molecular PCR test. The federal agency also said results should be considered in the context of an individual’s recent exposures, medical history as well as clinical signs and symptoms consistent with COVID-19.

The device is not to be used to 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,” the FDA added.

The InspectIR COVID-19 Breathalyzer was validated in a large study involving 2,409 individuals with both symptomatic and asymptomatic suspected infections. In addition to the high sensitivity and accuracy of the device, the study also found that in a population with low disease prevalence, where only 4.2 percent of individuals were positive for SARS-CoV-2, the test had a negative predictive value of 99.6 percent. This means individuals who obtain a negative result are likely truly negative in areas with low transmission.

The FDA said the COVID-19 breath test was also found to have a similar sensitivity (91 percent) in a follow-up clinical study focused on the omicron variant of the virus.

InspectIR expects to be able to manufacture around 100 instruments per week, which can allow for the evaluation of 160 samples per day. The company projects testing capacity to increase by approximately 64,000 samples per month.

In addition to its COVID-19 breath test, InspectIR has been developing non-invasive portable detection tools for opioid and cannabis use. The company says this is important given the growing opioid epidemic and the legal spread of medical and recreational cannabis and the lack of accurate mobile and roadside tests for their detection.

InspectIR Systems told CNN it is not revealing the price of the machine nor when it will be available.

The area of COVID-19 breath testing is in its infancy but it could soon balloon, no pun intended. Breathonix, a startup launched from the National University of Singapore, received a provisional marketing authorization in Singapore for its exhaled breath test for COVID-19.