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, will be breath sample which 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 Testing, to enhance the performance of detection along with clinicians.
The Sponsor has developed a rapid screening tool intended to determine if the subject tested is COVID-19-free (Negative to COVID-19).