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

Stanford University

Status: Completed

Conditions: Covid19

Treatments: Device: Saliva test kit

Study type: Interventional

Funder types: Other

Identifiers

NCT04568122

58629

Details and patient eligibility

About

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.

Enrollment: 1,277 patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,277 participants in 1 patient group

Saliva test

Experimental group

Description:

Participants perform each test assay, noting the results for comparison by technician, and completing survey questionnaires.

Treatment:

Device: Saliva test kit