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 |
Developer |
Description |
|
BreFence Go COVID-19 Breath Test System |
Breathonix |
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.
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