Rapid Turnaround, Home-based Saliva Testing for COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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Rapid Turnaround, Home-based Saliva Testing for COVID-19

Conditions
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Covid19

Intervention / Treatment
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* Device: Saliva test kit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Saliva test<br>Participants perform each test assay, noting the results for comparison by technician, and completing survey questionnaires. | Device: Saliva test kit<br>* Kit including tube with closed reagents using loop-mediated isothermal amplification (LAMP) assay to detect SARS-CoV-2 virus.<br>* Other names: SnapDx;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An indicator for discrepancy in interpretation of findings by participant versus by technician via photo (interrater reliability) | Primary Feasibility Outcome | Up to 5 days per participant | 
| An indicator for whether the home saliva test is positive as determined by the patient (to assess sensitivity and specificity by the patient) | Primary Validity Outcome | Up to 5 days per participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An indicator for ambiguous findings as measured by percent confidence (if < 80% confident) in interpretation of results by participant and by technician (ease of interpretation) | Secondary Feasibility Outcome | Up to 5 days per participant | 
| An indicator that the participant appropriately followed instructions for using the kit (≥ 80% confident) (ease of use) | Secondary Feasibility Outcome | Up to 5 days per participant | 
| An indicator for whether participant called technical support and by reason (e.g., processing was not possible due to broken part) (ease of use) | Secondary Feasibility Outcome | Up to 5 days per participant | 
| An indicator by participant that the sample was sufficient and reached the indicated line for sample integrity (sample integrity) | Secondary Feasibility Outcome | Up to 5 days per participant | 
| An indicator for whether the home saliva test is positive as determined by the technician (to assess sensitivity and specificity by the technician) | Secondary Validity Outcome | Up to 5 days per participant |