Two years after the world was ravaged by the coronavirus, a new diagnostic tool brings new possibilities for scientists, businesses and governments around the world. The FDA US Food and Drug Administration last week issued an emergency use-authorization (EUA) to the first COVID-19 diagnostic test – InspectIR COVID-19 Breathalyzer – that finds compounds associated with a SARS-CoV-2 infection in the breath samples.
To note, other Covid tests tend to consider nasal or saliva swabs. While the new test uses a breath exhale as a sample, others like polymerase chain reaction, or PCR, test considers nasal or saliva swabs. There are other rapid tests, which can be conducted at home as well.
InspectIR PNY-1000 COVID Testing Demo (Source: InspectIR Systems)
This test is significant because it comes at a time when the Centers for Disease Control and Prevention has notified that the US is witnessing a wave of the BA.2 omicron subvariant, making up around 86% of cases in the country.
In his statement, Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health said that FDA supports the developments in the field of developing COVID-19 tests that can help advance technologies to address the pandemic and better prepare the U.S. for the next public health emergency.
The InspectIR COVID-19 Breathalyzer test is a portable instrument the size of a carry-on luggage. According to the terms of the FDA, this new breath test for COVID-19 can be carried out in areas or environments where the patient specimen can be collected and analyzed, including doctor’s offices, hospitals and even mobile testing sites.
A qualified, trained operator needs to perform the test supervised by a health care provider licensed or authorized by the state law to prescribe tests. The test yields results in around three minutes.
The InspectIR COVID-19 Breathalyzer by InspectIR Systems LLC was tested on 2,409 participants, including persons with and without symptoms. According to the FDA, the test demonstrated 91.2% sensitivity (the density of positive samples the Breath test accurately identified) and 99.3% specificity (the percentage of negative samples the test accurately identified).
The FDA report announced that this latest COVID-19 study also illustrated that, in a population with 4.2% of persons found positive for the virus, the test showed a negative predictive value of 99.6%. This means that individuals who get a negative on the test are likely negative in areas where there is a low-disease prevalence.
The press statement revealed that the new COVID-19 test was conducted with similar sensitivity in a follow-up clinical study with a focus on the omicron variant.
When you exhale the breath, the InspectIR COVID-19 Breathalyzer separates and identifies chemical mixtures using the gas chromatography gas mass-spectrometry (GC-MS) technique to quickly detect five Volatile Organic Compounds (VOCs) related to SARS-CoV-2 infection.
When the InspectIR COVID-19 Breathalyzer detects the VOC markers of SARS-CoV-2 infection, a presumptive positive test result shows up and then it needs to be confirmed with a molecular test.
However, there is an important note. The FDA report said that the negative results should be viewed in the context of patient’s history, recent exposures, and the existence of clinical signs and symptoms associated with COVID-19, since they still do not eliminate the possibility of SARS-CoV-2 infection. Thus, they also should not be used as the key concern in the treatment or patient management decisions, including infection control decisions or isolation.
The report continued that the new InspectIR is expected to generate around 100 instruments every week to be used to test around 160 samples per day.
At the current level of production, testing capacity of the InspectIR COVID-19 Breathalyzer is expected to rise by roughly 64,000 samples per month.