Subjects will be recruited for the study during their scheduled appointments per clinical practice to the site, no separate study visit is required.

The participant's involvement in the study will be limited to one visit (per routine practice) only. No additional follow up is required.

For the purpose of the study a breath sample will be collected using the Breath Biopsy face masks. Collection of exhaled breath aerosols using these single use, disposable face masks will require subjects to breath normally into these face masks, the total collection time will not exceed one hour. It is expected to reduce collection times after initial validation steps to the shortest time providing sufficient diagnostic accuracy.

Given the non-invasive nature of these breath collections subjects can immediately provide up to two samples using the Breath Biopsy face masks. The breath collection should occur within 24 hours of the diagnostic sample.

Collected samples will be either frozen or shipped for rtPCR analysis of the presence of nCOVID-19 RNA. The two Breath Biopsy face masks can be used as technical replicates and/or to validate different storage conditions.