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

Launched by OWLSTONE LTD · Aug 7, 2020

Keywords

ClinConnect Summary

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 thereb...

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Eligibility criteria

• 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