N/A N=353 Diagnostic

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

Covid19

Bottom Line

View on ClinicalTrials.gov: NCT04568122 ↗

Enrolled (actual)

353

Serious AEs

0.0%

Results posted

Jan 2024

Primary outcome: Primary: Number of Matched Test Colormetric Interpretation as a Measure of Interrater Reliability — 52; 69; 97; 27 Completed tests

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Saliva test kit (Device)
Age: Pediatric, Adult, Older Adult · 2+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Matched Test Colormetric Interpretation as a Measure of Interrater Reliability	52; 69; 97; 27; 67; 93	—
PRIMARY Number of Positive Home Saliva Tests as Determined by the Patient	NA; NA; NA	—
SECONDARY Participant-rated Confidence in Interpreting Results	53; 61; 9; 2; 3; 3	—
SECONDARY Participant-rated Ease of Use	0; 5; 13; 6; 22; 52	—
SECONDARY Number of Participants That Called Technical Support	0; 0	—
SECONDARY Sample Integrity	78; 131; 25; 50	—
SECONDARY Sensitivity of Sample Test Kit	4	—
SECONDARY Specificity of Sample Test Kit	15; 10; 25	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04568122). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.