NCT04508556

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Owlstone Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Covid19

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-30
• Primary completion: 2020-12-19
• Completion: 2020-12-19
• First posted: 2020-08-11
• Last updated: 2021-04-01

Locations

1 site across 1 country: Netherlands