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SINGAPORE – Diagnosing a Covid-19 patient could soon be as easy as having the person breathe through a tube and getting results in less than a minute.
The breathalyzer-type diagnostic test kit, which is still in a prototype stage, is developed by Breathonix, a spin-off from the National University of Singapore (NUS).
So far, it has achieved an accuracy rate of more than 90 percent during a pilot clinical trial involving 180 patients at the National Center for Infectious Diseases (NCID), and researchers will continue to fine-tune the algorithm using data collected from the following phases. of the trial.
The researchers hope to recruit up to 600 patients over the next few months to validate the technology.
But Dr. Jia Zhunan, a NUS graduate and CEO of Breathonix, is confident that the breath test could be a game changer in Singapore’s fight against the coronavirus.
For one thing, the breath test is easy to administer and does not require specially trained personnel or laboratory processing that is generally required for polymerase chain reaction (PCR) tests.
“The results are generated in real time, making it an attractive solution for mass screening, especially in areas with high human traffic,” added Dr. Jia.
This could include areas like airports and dormitories.
How the test works
The Breathonix test is unlike any other kit currently on the market in that it does not detect viral fragments – which is what PCR tests detect – or viral proteins, detected by rapid antigen tests.
Instead, it records chemical changes in a patient’s breathing.
PHOTO SAN: TIMOTHY DAVID
Each exhale contains invisible particles known as volatile organic compounds (VOCs), which are produced by various biochemical reactions in human cells.
But the VOC signature of a healthy person’s breath is different than that of a person with a disease. The breath signature also differs from disease to disease.
“This results in detectable changes in a person’s respiratory profile,” explained Dr. Jia. “As such, VOCs can be measured as markers for diseases like Covid-19.”
Currently, breath tests are already available to diagnose conditions such as asthma and infections with Helicobacter pylori, a gastric disease.
The Breathonix test works by having a person first blow with a disposable mouthpiece attached to a high-precision breath sampler.
Exhaled air is collected and fed to a state-of-the-art mass spectrometer for measurement. Machine learning software analyzes the VOC profile and generates the result in less than a minute.
“The disposable mouthpiece our system uses has a one-way valve and a saliva trap, which prevents inhalation and saliva from entering the machine. This makes cross contamination unlikely,” said Du Fang, director of operations. by Breathonix.
NCID Clinical Director Dr. Shawn Vasoo told The Straits Times that while the new breath test may serve as a screening test, a confirmatory PCR test will likely still be needed to diagnose Covid-19.
He said that while the breath test looks promising, more validation work needs to be done.
“It is still too early to compare VOC diagnoses with PCR, which is the current diagnostic ‘gold standard’, as more data is needed,” added Dr. Vasoo.
Translate the research
Breathonix parted ways with NUS under the NUS Graduate Research Innovation Program in 2019, with the initial goal of using respiratory technology to diagnose patients with lung cancer.
Dr. Jia, who completed her PhD research on breath VOC testing for lung cancer, was inspired to enter the field after finding a 1989 article in the medical journal The Lancet.
The magazine had reported on how a 44-year-old woman sought treatment for an injury to her left thigh because her dog kept sniffing at her. The diagnosis was melanoma, a type of skin cancer, which was still treatable.
This led Dr. Jia to think about how other diseases could be diagnosed in this way. Lung cancer, which is often undiagnosed and rapidly progressing, was one area that Breathonix was focusing on.
But the Covid-19 pandemic has delayed plans to develop the technology for lung cancer.
However, Breathonix COO Du Fang saw an opportunity: “retraining” the algorithm to recognize the VOC signatures of Covid-19 patients.
This was done based on data from 180 patients recruited from the NCID, among whom 48 were positive for Covid-19 and 132 negative.
The results were encouraging, Mr. Du said.
So far, the test has shown a sensitivity rate of around 93 percent, meaning the test accurately diagnosed more than nine out of 10 Covid-19 patients. The breath test also has a 95 percent specificity rate, which means that it accurately diagnoses a healthy patient as being free from infection.
Professor Freddy Boey, senior vice president for graduate education and research translation at NUS, said the technology to analyze VOCs accurately and quickly was first developed by Dr. Jia when she was a PhD student, for screening early lung cancer.
He said: “The technology was born through NUS GRIP, in the start-up Breathonix, and is now contributing to Singapore’s fight against Covid-19. This demonstrates the enormous potential of local technologies and Singapore’s deep tech startups. .. “
Dr. Vasoo said that the NCID hopes that new technologies that are fast and provide real-time data can be available as an accurate detection tool for Covid-19.
“I think this would be welcome, especially in specific settings where large numbers of people may need to be screened,” he said, although there is no set timeline for this.
“A lot will depend on more validation work that many of us are busy with, which will help us better evaluate its performance,” he added.
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