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OpenTrials
Completed

NCT Number: NCT04568122

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SHC Valley Care, Pleasanton, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saliva test kit

Device

Kit including tube with closed reagents using loop-mediated isothermal amplification (LAMP) assay to detect SARS-CoV-2 virus.

Other names: SnapDx

Primary outcomes

  1. Number of Matched Test Colormetric Interpretation as a Measure of Interrater Reliability

    Time frame: 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.

  2. Number of Positive Home Saliva Tests as Determined by the Patient

    Time frame: Up to 5 days per participant

    Validity Outcome.

Secondary outcomes

  1. Participant-rated Confidence in Interpreting Results

    Time frame: 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."

  2. Participant-rated Ease of Use

    Time frame: 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."

  3. Number of Participants That Called Technical Support

    Time frame: 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).

  4. Sample Integrity

    Time frame: 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.

  5. Sensitivity of Sample Test Kit

    Time frame: 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.

  6. Specificity of Sample Test Kit

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • BioBox

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 29, 2020
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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