Rapid Turnaround, Home-based Saliva Testing for COVID-19
Purpose
The aim of the study is to demonstrate the feasibility and validity of a saliva based home surveillance monitoring test for SARS-CoV-2 infection. Participants will be asked to carry out as many tests as are included in the bag they are provided, on a daily basis until they are used up.
Condition
- Covid19
Eligibility
- Eligible Ages
- Over 2 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Hospitalized patients - Hospitalized at Stanford Health Care for COVID-related complications and tested positive for SARS-CoV-2 with a PCR-based test - Able to understand and consent to study and with a clinical trajectory likely to be consistent with multi-day participation - High-risk/positive population - Seeking testing for suspected COVID or a participant in a study of COVID-positive outpatients - Own an internet-enabled phone or device capable of loading web pages, receiving text messages, and taking/uploading photos. - Willing to participate in the study for 6 months - Low-risk population - Own an internet-enabled phone or device capable of loading web pages, receiving text messages, and taking/uploading photos. - Willing to participate in the study for 6 months
Exclusion Criteria
- All participants: - Participants with salivary gland dysfunction (including patients with Sjogren's disease or those with xerostomia associated with lupus or rheumatoid arthritis) - Participants will not be eligible if they identify any reason they are unable to participate in the study - High-risk/positive population - Participants who have color blindness - Participants unable to operate the SnapDx device - Low-risk population - Participants with prior confirmed SARS-CoV-2 infection - Participants who have color blindness - Participants unable to operate the SnapDx device
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Enrollment is to a single group. Specific eligibility criteria apply depending on whether the participant is a hospitalized patient, in high-risk or infected population, or low-risk population
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Saliva test |
Participants perform each test assay, noting the results for comparison by technician, and completing survey questionnaires. |
|
Recruiting Locations
More Details
- NCT ID
- NCT04568122
- Status
- Completed
- Sponsor
- Stanford University