Health Sciences Authority (HSA) has granted provisional authorization for the COVID-19 breathalyzers ‘BreFence Go COVID-19 Breath Test System’ and ‘TracieX Breathalyzer’, on 17 May 2021 and 27 May 2021, respectively. These breathalyzers detect COVID-19 infection by analyzing breath samples from individuals and report the results in 1 – 2 minutes.

Both of these breathalyzers were developed by local start-up companies. Performance of the breathalyzers was compared to the conventional Polymerase Chain Reaction (PCR) tests (shown in the table below) and was validated by clinical studies:

Name of Breathalyzer



BreFence Go COVID-19 Breath Test System


Detects specific volatile organic compounds in human breath samples using mass spectrometry.

Sensitivity: 85.3%

Specificity: 97.0%

TracieX Breathalyser

Silver Factory Technology

Analyses human breath composition using Raman spectrometry.

Sensitivity: 95.0%

Specificity: 97.8%

Despite HSA approval, manufacturers and product owners of these products are still required to collect data and monitor the real-world use of their breathalyzers. HSA requires them to submit additional data aside from the ongoing clinical studies post-approval. HSA will continue to monitor the performance of these tests to ensure they are safe and effective in detecting COVID – 19 infections.




HSA Grants Provisional Authorization For ‘Brefence Go Covid-19 Breath Test System’ And ‘Traciex Breathalyser’ For Detection Of Covid-19 Infection