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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Device: Breath Biopsy face masks with removable filters and fitted PVA strip
* Diagnostic Test: Nasopharyngeal swab
* Diagnostic Test: oropharyngeal swabs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Breath Biopsy face masks with removable filters and fitted PVA strip|Device developed for collection of breath samples|
|Diagnostic Test: Nasopharyngeal swab|Is a method for collecting a clinical test sample of nasal secretions from the back of the nose and throat.|
|Diagnostic Test: oropharyngeal swabs|Is a method for collecting a clinical test sample from the back of the throat.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive control for technical validation | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of test performance | The aim is to assess the test performance of the Breath Biopsy RD devices in a real live clinical setting. Subjects with a high clinical suspicion of nCOVID-19 based on clinical triage will be requested to participate. A single Breath Biopsy RD collector will be collected in parallel with the standard diagnostic work-up consisting of a CT-scan and a nasopharyngeal swab. | 1 year |