HSA GRANTS PROVISIONAL AUTHORISATION FOR ‘BREFENCE GO COVID-19 BREATH TEST SYSTEM’ AND ‘TRACIEX BREATHALYSER’ FOR DETECTION OF COVID-19 INFECTION

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.

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.

Published: 11 Jun 2021

Regulatory Updates