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

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Device: Saliva test kit

• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Saliva test	Saliva test kit	Participants perform each test assay, noting the results for comparison by technician, and completing survey questionnaires.

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