The Health Sciences Authority (HSA) in Singapore has granted provisional authorisation for the COVID-19 breathalysers “BreFence Go COVID-19 Breath Test System” and “TracieX Breathalyser” since May this year. These breathalysers detect COVID-19 infection by analysing breath samples from individuals and report the results in 1-2 minutes.
These two breathalysers were developed by local start-ups and have been validated in clinical studies where their results have been compared to those of Polymerase Chain Reaction (PCR) tests, with sensitivity ranging from 85-95% and specificity of more than 97%.
The companies are required to collect relevant accuracy and safety data as well as monitor the real-world use of their tests. Moreover, HSA also requires additional data from ongoing clinical studies to be submitted post-approval for HSA to ensure the continued safety and efficacy of these tests.
Pre-order for the BreFence Go COVID-19 Breath Test System breathalyser can be done via the company’s website https://breathonix.com/covid-19/. There currently no information on whether the TracieX Breathalyser is available for public/commercial purchase.
For more information on HSA’s provisional authorisation of these tests, please click here.
Video: Breathonix via YouTube
Images: NTU Singapore and Shutterstock (header)