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.
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.
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
OLVG
Amsterdam, Netherlands