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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1277 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-20

Study Completion Date

2022-12-10

Brief Summary

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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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Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Enrollment is to a single group. Specific eligibility criteria apply depending on whether the participant is a hospitalized patient, in high-risk or infected population, or low-risk population

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Saliva test

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

Group Type EXPERIMENTAL

Saliva test kit

Intervention Type DEVICE

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

Interventions

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Saliva test kit

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

Intervention Type DEVICE

Other Intervention Names

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SnapDx

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes