N/A
Completed N=353
Rapid Turnaround, Home-based Saliva Testing for COVID-19
Source: ClinicalTrials.gov NCT04568122 ↗Enrolled (actual)
353
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Number of Matched Test Colormetric Interpretation as a Measure of Interrater Reliability — 52; 69; 97; 27 Completed tests
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.
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 | — |
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
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. Informational only — not medical advice.