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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Device: Saliva test kit

• Study Type: Interventional
• Enrollment (Actual): 1277
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Team; Phone Number: 650-374-0085; Email: snapdxsupport@stanford.edu

Study Locations

• United States
  • California
    • Pleasanton, California, United States, 94566
      • SHC Valley Care
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Matched Test Colormetric Interpretation as a Measure of Interrater Reliability	Feasibility Outcome. Discrepancy in interpretation of colormetric readout by participant versus by technician via photo. Passed test = void of manufacturing or user error.	Up to 5 days per participant
Number of Positive Home Saliva Tests as Determined by the Patient	Validity Outcome.	Up to 5 days per participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant-rated Confidence in Interpreting Results	Validity Outcome (ease of interpretation). Number of participants responding by category when asked to provide a rating on being "Confident in Interpreting Results."	Up to 5 days per participant
Participant-rated Ease of Use	Validity Outcome (ease of use). Number of participants responding by category when asked to provide a rating on SnapDx being "Easy to Learn to Use."	Up to 5 days per participant
Number of Participants That Called Technical Support	Feasibility Outcome (ease of use). Number of participants that called technical support, by reason (e.g., processing was not possible due to broken part).	Up to 5 days per participant
Sample Integrity	Feasibility Outcome. The participants were asked to determine whether the saliva sample filled up to the indicated line, and if there were bubbles present as a measure of sample integrity.	Up to 5 days per participant
Sensitivity of Sample Test Kit	Validity Outcome. Analysis of saliva samples provided by participants and run through sample test kit by study lab. Sensitivity = number of true positives out of the positive tests run. Samples may have been split and run through more than one test.	Up to 5 days per participant
Specificity of Sample Test Kit	Validity Outcome. Analysis of saliva samples provided by participants and run through sample test kit by study lab. Specificity = number of true negatives out of negative tests run. Samples may have been split and run through more than one test.	Up to 5 days per participant

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: BIOBOX
• Investigators: Principal Investigator: Manisha Desai, PhD, Stanford University; Principal Investigator: Manu Prakash, PhD, Stanford University; Principal Investigator: Euan A Ashley, MRCP, DPhil, Stanford University

Publications and helpful links

Helpful Links

• https://www.snapdx.org/ (for more information and how to enroll)

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Actual): December 10, 2022
• Study Completion (Actual): December 10, 2022

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: September 26, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 58629

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes