The InspectIR COVID-19 Breathalyzer is 91.2 per cent accurate at identifying positive samples and 99.3 per cent accurate with negative samples, according to the FDA.
ADVERTISEMENTMore than two years into the COVID-19 pandemic, many of us are fed up with nasal PCR tests. Fortunately, regulators are now approving alternatives that don’t involve torturing our nostrils.
The US Food and Drug Administration (FDA) has just issued an emergency use authorisation for the country’s first COVID-19 breath test, which can provide results in less than three minutes.
The FDA described the InspectIR COVID-19 Breathalyzer as “the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection”.
It uses a technique called gas chromatography gas mass-spectrometry (GC-MS) to separate and identify chemical mixtures and rapidly detect five volatile organic compounds (VOCs) associated with SARS-CoV-2 infection in exhaled breath.
The FDA said the device was 91.2 per cent accurate at identifying positive test samples and 99.3 per cent accurate at identifying negative test samples.
The test performed with similar sensitivity in a follow-up clinical study focused on the Omicron variant, it added.
Emergency authorisation was given on Thursday for the use of the equipment, which is about the size of a piece of carry-on luggage.
The FDA said it can be used by qualified medical professionals, in doctor’s offices, hospitals and mobile testing sites.
COVID breath tests
The InspectIR COVID-19 Breathalyzer is not the first COVID breath test to be approved by a government.
A number of countries initiated development and testing of COVID breath tests during the pandemic, with the Netherlands even rolling out the tests widely.
After months of trials, Dutch health authorities found the SpiroNose breathalyser to be reliable when it shows a negative result, and the machine was rolled out across facilities in Amsterdam in February 2021.
A positive breathalyser test, however, needs to be followed by a polymerase chain reaction (PCR) test to confirm a coronavirus infection. The PCR test is considered to be the most accurate.
The same goes with the InspectIR COVID-19 Breathalyzer, which the FDA said needs to be followed up with a molecular test (such as a PCR lab test) in the event of a positive result.
Still, regulators are hoping a greater variety of tests that are more comfortable for patients - whether they’re used at home or in a medical setting - can make it easier to track infections and tackle future outbreaks.
“The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the US for the next public health emergency,” the agency said.
InspectIR expects to be able to produce around 100 instruments per week, which can each be used to evaluate about 160 samples a day, the FDA said.
“At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month,” it added.
