As the great minds of the world are on their mission against COVID-19, diagnosis of the infection is getting easier by the day. The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) on Thursday for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection.
Developed by InspectIR Systems, the test can be performed in environments where the patient specimen is both collected and analyzed using an instrument about the size of a piece of carry-on luggage, as per the press statement of the FDA. The agency also revealed that the test is performed by a qualified and trained operator under the supervision of a health care provider licensed or authorized by state law to prescribe tests. Interestingly, the test can provide results in less than three minutes.
“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health said in a statement.
According to the US agency, the performance of the COVID-19 Breathalyzer was validated in a large study of 2,409 individuals, including those with and without symptoms. The study results revealed 91.2 per cent sensitivity (the percentage of positive samples the test correctly identified) and 99.3% specificity (the percentage of negative samples the test correctly identified).
The study also highlighted that, in a population with only 4.2 per cent of individuals who are COVID-19 positive, the test had a negative predictive value of 99.6 per cent, which means that people who receive a negative test result may actually be negative. Additionally, the test performed with similar sensitivity in a follow-up clinical study focused on the omicron variant of the COVID-19 virus.
The FDA also informed that the InspectIR COVID-19 Breathalyzer uses a technique known as gas chromatography gas mass-spectrometry (GC-MS) to separate and identify chemical mixtures and rapidly detect five Volatile Organic Compounds (VOCs) linked with COVID-19 infection in exhaled breath.
After the breathalyser detects the presence of VOC markers of SARS-CoV-2, a presumptive (unconfirmed) positive test result is returned and should be confirmed with a molecular test, the FDA informed. Meanwhile, 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.
The federal agency also warned that the negative result of the breathalyser does not rule out SARS-CoV-2 infection and should not be used as the only basis for treatment or patient management decisions, including infection control decisions.
The FDA also stated that the manufacturing company, InspectIR, expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day. “At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month,” the US body said in a statement.