Regulatory Updates
HSA GRANTS PROVISIONAL AUTHORISATION FOR ‘BREFENCE GO COVID-19 BREATH TEST SYSTEM’ AND ‘TRACIEX BREATHALYSER’ FOR DETECTION OF COVID-19 INFECTION
Audiences
Consumer
Healthcare professional
Industry member
Product type
Medical devices
11 June 2021
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The Health Sciences Authority (HSA) has granted provisional authorisation for the COVID-19 breathalysers ‘BreFence Go COVID-19 Breath Test System’ and ‘TracieX Breathalyser’, on 17 May 2021 and 27 May 2021 respectively. These breathalysers detect COVID-19 infection by analysing breath samples from individuals and report the results in 1-2 minutes.
2 The two breathalysers were developed by local start-up companies and have been validated in clinical studies where their results have been compared to those of Polymerase Chain Reaction tests.
Table caption
Name of breathalyser | 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% |
3 Companies are required to collect relevant accuracy and safety data and monitor the real-world use of their tests. 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.
4 HSA will continue to closely monitor the clinical performance of these tests as they are being deployed locally and ensure that these tests continue to be safe and effective in detecting COVID-19 infections.