A COVID-19 breath test that returns accurate results within a minute has received provisional authorisation from Singapore health regulators, reports MedicalBrief. The test achieved a sensitivity of 93% and specificity of 95% in a clinical trial.
Developed by Breathonix, a spin-off company of the National University of Singapore (NUS), it could play a key role in reviving the pandemic-hit travel industry.
NUS Professor Freddy Boey, who led the university team that developed the BreFence Go COVID-19, said that the pandemic was likely to go on for several years, "Mass, repeated testing has to be widely adopted as a key public health strategy to support the safe reopening of economies."
The BreFence test works by detecting Volatile Organic Compounds (VOCs) present in a person’s exhaled breath. VOCs are produced by various biochemical reactions in human cells. As the VOC signature from a healthy person’s breath vary from that of a person with an illness, changes in VOCs can be measured as markers for diseases like COVID-19.
The breath test is simple to administer by trained personnel but does not require medically trained staff or laboratory processing. A person only needs to blow into a disposable one-way valve mouthpiece connected to a high-precision breath sampler. The exhaled breath is collected and fed into a cutting-edge mass spectrometer for measurement. A proprietary software algorithm analyses the VOCs biomarkers, and generates results in less than a minute. Any individual screened positive will need to undergo a confirmatory Polymerase Chain Reaction (PCR) COVID-19 swab test.
Dr Jia Zhunan, Chief Executive Officer of Breathonix, explained, “Our breath test is non-invasive. Users only need to breathe out normally into the disposable mouthpiece provided, so there will not be any discomfort. Cross-contamination is unlikely as the disposable mouthpiece has a one-way valve and a saliva trap to prevent inhalation or saliva from entering the machine.”
The breath analysis system underwent clinical trials at three locations conducted from June 2020 to April 2021. In Singapore, trials were carried out at the National Centre for Infectious Diseases and Changi Airport while the third trial was carried out in Dubai, in collaboration with the Dubai Health Authority and the Mohammed Bin Rashid University of Medicine and Health Sciences.