Performance Assessment of SARS-CoV-2 Detection Breath Biopsy - SARS-CoV-2 Study

Performance Assessment of SARS-CoV-2 Detection Through Analysis of Exhaled Breath Aerosols

The primary aim of this study is to investigate the performance of Breath Biopsy RD for the detection of SARS-CoV-2 in both a clinical and at home setting.

This study aims to evaluate Owlstone Medical's Breath Biopsy RD Collectors for the detection of SARS-CoV-2 infection. These single use disposable breath capture devices can be used independently by individuals and shipped to be analysed in a central lab for the presence of SARS-CoV-2 using established existing PCR assays available in any reference lab. The aerosol collectors furthermore directly sample exhaled breath aerosols. As such they directly sample the primary transmission route for the virus. This could result in a higher rate of retrieval of viral RNA in infected individuals thereby increasing the sensitivity of the applied PCR assay. This is underpinned by the fact that CT abnormalities in the lower airways appear to occur prior to upper respiratory tract samples becoming positive in cases suffering from nCOVID19, suggesting lower airway viral loads could be higher. Combined, this could enable more widespread access to diagnostics, reduce the need for repeat testing, decrease the need for healthcare professionals to perform diagnostic tests and reduce cross-contamination risk.

Inclusion Criteria:

• Any adult >18 years with either a confirmed (phase 1) or suspected (phase 2&3) SARS-CoV-2 infection will be eligible to participate in this study.

Exclusion Criteria:

• Subject who are deemed unlikely to be able to maintain oxygen saturation of greater than 90% while breathing room air for 30 seconds
• Subject who require non-invasive ventilation or high flow nasal oxygen
• Subject who require inotropic medication to maintain adequate organ perfusion
• Subject who have a communication barrier and / or unable to comply with the instructions to use the Breath Biopsy test