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

Not Applicable

Completed

• Conditions: Covid19

• Registration Number: NCT04568122
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-25
• Study First Submitted QC: 2020-09-26
• Study First Posted: 2020-09-29
• Study Start: 2020-11-20
• Primary Completion: 2022-12-10
• Study Completion: 2022-12-10
• Results First Submitted: 2023-11-20
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-18
• Last Update Submitted: 2023-12-18
• Results First Posted: 2024-01-10
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1277

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Participant-rated Ease of Use	Up to 5 days per participant	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."
Number of Participants That Called Technical Support	Up to 5 days per participant	Feasibility Outcome (ease of use). Number of participants that called technical support, by reason (e.g., processing was not possible due to broken part).
Participant-rated Confidence in Interpreting Results	Up to 5 days per participant	Validity Outcome (ease of interpretation). Number of participants responding by category when asked to provide a rating on being "Confident in Interpreting Results."
Sample Integrity	Up to 5 days per participant	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.
Sensitivity of Sample Test Kit	Up to 5 days per participant	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.
Specificity of Sample Test Kit	Up to 5 days per participant	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.

Trial Locations

Locations (2)

SHC Valley Care; 🇺🇸 Pleasanton, California, United States

Stanford University; 🇺🇸 Stanford, California, United States