Performance Assessment of SARS-CoV-2 Detection Through Analysis of Exhaled Breath Aerosols
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Owlstone Ltd
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Positive control for technical validation
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
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
Outcomes
Primary Outcomes
Positive control for technical validation
Time Frame: 1 year
The purpose of this stage is to confirm the optimal extraction protocol to detect the presence of SARS-CoV-2 from the aerosols captured in the Breath Biopsy RD device. Up to two Breath Biopsy RD sample will be collected alongside a nasopharyngeal. The swab obtained during this stage is to be analysed in parallel to the extracted breath aerosols in the lab of the lab and will be used as a positive control.
Secondary Outcomes
- Evaluation of test performance(1 year)