On May 17, 2021, Singapore authorities have provisionally approved a COVID-19 breathalyser test, BreFence Go COVID, developed by a start-up Breathonix, National University of Singapore (NUS), that aims to show whether someone is infected with the coronavirus within a minute. The test has so far undergone three clinical trials, two in Singapore and another in Dubai. It achieved a sensitivity of 93 per cent and specificity of 95 per cent in one early Singapore-based pilot study that involved 180 patients. The Health Sciences Authority’s website has confirmed the approval, the first system to secure provisional authorisation in Singapore.
Procedure of the Test
The BreFence Go is a real-time, non-invasive COVID-19 Breath Test System intended for the qualitative detection of volatile organic compounds (VOCs) in the human breath. The VOCs being detected are indicative of the presence of COVID-19 disease. The BreFenceTM Go is intended for use in point-of-care settings, hospitals, clinical laboratories and clinical settings by trained operators. Operators of this system need not be trained healthcare professionals. Positive results indicate the presence of COVID-19 infection. Clinical correlation with patient history and other diagnostic information may be required to determine infection status. Negative results should be treated as presumptive, although they do not rule out COVID-19 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.
The test consists of a disposable single-use mouthpiece, a breath sampler, and a mass spectrometer. A person only needs to exhale into a disposable one-way valved mouthpiece connected to a high-precision breath sampler. The exhaled breath is collected and fed into a mass spectrometer for measurement. Then the machine learning software analyses the volatile organic compounds (VOCs) profile and generates the result in less than one minute. VOCs are consistently produced by various biochemical reactions in human cells. Different diseases cause specific changes to the compounds, resulting in detectable changes in a person’s breath profile. Therefore, VOCs are measured as markers for diseases like COVID-19 and lung cancer.
There is no risk of cross-contamination or cross-infection involved in getting this test as it is conducted by blowing a single breath into the sampler with a one-way disposable mouthpiece and a saliva trap, which prevents inhalation and any saliva from entering the machine. The test must be administered by trained persons even if the system can be processed outside of a formal lab setting and does not have to be overseen by medical professionals.
The price is about US$ 3.75 to 15, depending on the quantity.
Breathonix, founded in late 2019, was initially spun out of the National University of Singapore to develop breath-testing technology to detect cancer. The start-up began by developing an algorithm that could detect volatile organic compounds related to lung cancer, tuberculosis, and nasopharyngeal cancer. Breathonix was the MedTech Sector Winner (out of 2,400 start-ups) of Slingshot 2019 competition. The technology of breath analysis has developed from over six years of breath analysis research in NUS.
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