Mass deployment of COVID-19 breathalysers that produce results on the spot may soon happen here.

This will facilitate safe travel arrangements and screenings at large-scale events.

The Straits Times has learnt that local medical technology firm Silver Factory Technology is working with the National Centre for Infectious Diseases (NCID), Changi Airport and security firm Certis to develop its breathalysers.

Silver Factory's breathalyser, TracieX, has been shown to be almost as accurate as polymerase chain reaction (PCR) tests, while taking a fraction of the time - at two minutes - to turn in results.

Compared with PCR tests - the gold standard for testing - the disposable breathalyser's sensitivity rate so far has been over 95 per cent, and its specificity, more than 99 per cent. Sensitivity refers to a test's ability to identify those infected as positive, while specificity refers to a test's ability to correctly identify those not infected as negative.

It is also cheaper, costing around US$20 (S$27) each currently.

Trials have already started at the NCID, Changi Airport Terminal 1 and Certis, with a total of more than 400 individuals tested to date, Silver Factory said.

In an unblinded trial at Changi that began last month, arriving passengers were selected randomly and asked to volunteer for the trial by providing a breath sample.

The test site was set up with the help of NCID, which evaluated its biosafety protocols and monitored and analysed the data collected.

"Breathalyser tests are less invasive, more cost-effective and can deliver results in two minutes or less, which, if proven reliable, will make the airport experience for passengers a smoother one and give reopening efforts a boost," said Changi Airport Group's senior vice-president of passenger experience Albert Lim.

Silver Factory, founded in January last year as a spin-off from Nanyang Technological University, aims to produce at least 200,000 breathalysers a month from June, potentially ramping up production to two million a month. The product's cost price is expected to fall once large-scale production begins.

Sensor chips will be produced in Silver Factory's upcoming 300 sq m pilot plant in Tuas - roughly the size of three five-room Housing Board flats - while home-grown manufacturing company Dou Yee Technologies will assemble the devices.

Further studies are also set to begin soon at Changi Airport, NCID and some hospitals in Malaysia, Silver Factory said.

At least 1,000 participants will be recruited in Singapore in all for both the current and upcoming studies, with this number potentially extending to 2,000, said Dr Shawn Vasoo, head of the Infectious Disease Research Laboratory and clinical director of NCID.

Associate Professor Ling Xing Yi, one of the co-founders of Silver Factory, told ST that trials will be expanded to Malaysia due to the low number of COVID-19 cases here.

Silver Factory aims to apply for regulatory approval from the Health Sciences Authority (HSA) by June.

Once approved, Certis will also use these breathalysers in its current COVID-19 testing operations, Mr Joseph Tan, the security firm's senior managing director and head of technology services, told ST.

The breathalyser "delivers results in just two minutes with a high degree of accuracy and is able to do crowd screening... for aviation and cruise operations, government checkpoints, immigration clearance and at healthcare and medical facilities", Mr Tan added.

Certis will have exclusive rights to market this breathalyser in its key markets of Singapore, Australia, Hong Kong, Macau and Qatar.

Another start-up, Breathonix, is running trials of its own breathalyser at three sites - Changi Airport, NCID and in Dubai - with over 3,000 people tested in total.

It aims to get HSA approval by the first half of this year.

"This trial will help Breathonix better understand and improve the actual deployment workflow for our breath test station," said its chief executive Jia Zhunan.

How the device works
Silver Factory Technology's TracieX breathalyser uses a sensor chip to identify the molecular fingerprint of volatile organic compounds present in the exhaled breath of COVID-19 patients.

A disposable breath collection chamber with infection control features securely traps any contagious material within the chamber, thus preventing direct exposure of these materials to others, such as healthcare workers.

Current Studies

Unblinded studies are ongoing at Changi Airport's Terminal 1 and the National Centre for Infectious Diseases (NCID), where participants have prior knowledge of their COVID-19 status.

Participants who volunteer to be part of the study will take two tests: the breathalyser and polymerase chain reaction (PCR) tests.

The PCR test result is known before the breathalyser test is taken. The test results are then compared.

Participants first breathe into the breathalyser for around 10 seconds before the device is inserted into a portable reader to obtain a readout. The whole process takes less than two minutes.

The Next Step

In the next stage of trials, blinded studies will be conducted in Changi Airport, NCID and several hospitals in Malaysia.

In blinded studies, those analysing the breathalyser readouts are unaware of the participant's COVID-19 PCR results. This removes the possibility of bias.

Dr Shawn Vasoo, head of the Infectious Disease Research Laboratory and clinical director at NCID, said: "This is an important part of diagnostic trials to make sure that the tests are performing as intended. Participants of the blinded study include NCID patients and travellers on selected flights at Changi Airport."

The Future

Silver Factory is currently working with Enterprise Singapore to take this technology beyond Singapore's shores.

Security firm Certis, one of Silver Factory's partners, will deploy these breathalysers in its COVID-19 testing operations once they have received the necessary approvals.

Certis also plans to deploy blockchain technology to encrypt test results for confidentiality, Mr Joseph Tan, the firm's senior managing director and head of technology services, told The Straits Times.

Beyond COVID-19, Silver Factory is also working with Temasek Life Sciences Accelerator (TLA) to apply this technology to other areas.

One such example will be to use volatile organic compounds as accurate biomarkers to get a better understanding of infection in humans and other organisms in areas such as healthcare and agriculture.

TLA will also be investing in Silver Factory, together with partners and venture capitalists, with an undisclosed sum, said Mr Peter Chia, chief executive of TLA and Temasek Life Sciences Laboratory.

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Source: The Straits Times © Singapore Press Holdings Limited. Permission required for reproduction.