The Breathe Study
Research type
Research Study
Full title
Clinical Validation of Biosafety Technologies’1 Breath Analyser tests (“Bio Safety Test”) for the the diagnostic device and to assess the comparative performance with the RT-PCR tests currently being deployed in the NHS.
IRAS ID
297589
Contact name
Ilan Lieberman
Contact email
Sponsor organisation
BioSafety Technologies Ltd , TERAHERTZ Group LTD
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
A practical solution to transit safely out of the current coronavirus disease 19 (COVID-19) pandemic must include the implementation of an effective testing, tracing and tracking system. However, this requires a reliable and clinically validated diagnostic platform for the sensitive and specific identification of SARS-CoV-2.
BioSafety Technologies Ltd, has developed a rapid screening tool intended to determine if the subject tested is COVID-19-free (Negative to COVID-194). Following regulatory approval such as FDA or MHRA, this solution eventually intends to assist in mobilizing the economy and allow people a swift return to daily activities.
The rapid diagnostic solution encloses the following elements:
• BioSafety Station composed of TeraSystem, and it’s Scanner (see Annex 3)
• Breath Analyzer Testing Kit - a disposable TearTube including encapsulated membrane within the TeraTube.Within this proposed project, the NHS will collect two diagnostic or screening tests per participant. One sample will be used by NHS and be run through regular diagnostics. The second sample will be tested using the BioSafety Technologies Ltd, rapid screening tool. This will use a pre-defined protocol. These tests would then be compared to assess the diagnostic efficacy including sensitivity and specificities. We will be aiming to achieve a significant comparison to ensure certainty and to exploit the information for proposing a novel diagnostic system to enhance capabilities to scale up the testing of patients. The proposed activity involves clinical validation of BioSafety Testung, to enhance the performance of detection along with clinicians.
REC name
London - Harrow Research Ethics Committee
REC reference
21/PR/1111
Date of REC Opinion
14 Oct 2021
REC opinion
Further Information Favourable Opinion