Breath collection protocol for SARS-CoV-2 testing in an ambulatory setting

Area of Science:

• Clinical Diagnostics
• Infectious Disease Research
• Respiratory Medicine

Background:

• The COVID-19 pandemic necessitated rapid, non-invasive diagnostic tests.
• Breath analysis emerged as a potential game-changing diagnostic tool.
• SARS-CoV-2 posed safety challenges for breath sample collection and analysis.

Purpose of the Study:

• To develop and prospectively evaluate a safe workflow for collecting and processing SARS-CoV-2 breath samples in an ambulatory care setting.
• To assess the impact of respiratory filters on breath sample integrity and reproducibility.

Main Methods:

• A prospective, observational study was conducted at community COVID-19 testing sites.
• Breath samples were collected from patients undergoing RT-PCR testing using Tedlar® and BioVOC-2™ devices.
• Samples were processed using Tenex tubes, dry purging, and GC-Bench-ToF-HD analysis.

Main Results:

• 528 breath samples from 393 participants were successfully collected and processed.
• Sample collection occurred during the emergence of the Delta Variant, prior to widespread vaccination.
• No staff infections were reported during the study period.

Conclusions:

• A safe and effective workflow for handling infectious SARS-CoV-2 breath samples was demonstrated.
• The workflow facilitated collection, transport, storage, and analysis of breath samples.
• Respiratory filters were omitted due to their negative impact on sample integrity.