Trial Outcomes & Findings for Rapid Turnaround, Home-based Saliva Testing for COVID-19 (NCT NCT04568122)
NCT ID: NCT04568122
Last Updated: 2024-01-10
Results Overview
Feasibility Outcome. Discrepancy in interpretation of colormetric readout by participant versus by technician via photo. Passed test = void of manufacturing or user error.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1277 participants
Primary outcome timeframe
Up to 5 days per participant
Results posted on
2024-01-10
Participant Flow
1277 participants signed consent; 353 were allocated to a study arm: participants who came to the study site to collect a kit (First, Second, and Third Distribution groups) or provided saliva samples (Positive Saliva Collection and Negative Saliva Collection groups).
Participant milestones
| Measure |
Saliva Test - First Distribution
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
|
Saliva Test - Second Distribution
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
|
Saliva Test - Third Distribution
Participants provide one test sample at study visit using the saliva test kit to detect the SARS-CoV-2 virus.
|
Positive Saliva Collection
Participants provide one saliva sample confirmed positive for SARS-CoV-2 virus used in lab to validate device function.
|
Negative Saliva Collection
Participants provide one saliva sample confirmed negative for SARS-CoV-2 virus used in lab to validate device function.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
94
|
112
|
135
|
9
|
3
|
|
Overall Study
Completed One Test
|
46
|
68
|
131
|
9
|
3
|
|
Overall Study
Completed 2 Tests
|
32
|
53
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
46
|
68
|
131
|
9
|
3
|
|
Overall Study
NOT COMPLETED
|
48
|
44
|
4
|
0
|
0
|
Reasons for withdrawal
| Measure |
Saliva Test - First Distribution
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
|
Saliva Test - Second Distribution
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
|
Saliva Test - Third Distribution
Participants provide one test sample at study visit using the saliva test kit to detect the SARS-CoV-2 virus.
|
Positive Saliva Collection
Participants provide one saliva sample confirmed positive for SARS-CoV-2 virus used in lab to validate device function.
|
Negative Saliva Collection
Participants provide one saliva sample confirmed negative for SARS-CoV-2 virus used in lab to validate device function.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
48
|
44
|
4
|
0
|
0
|
Baseline Characteristics
Rapid Turnaround, Home-based Saliva Testing for COVID-19
Baseline characteristics by cohort
| Measure |
Saliva Test - First Distribution
n=94 Participants
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
|
Saliva Test - Second Distribution
n=112 Participants
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
|
Saliva Test - Third Distribution
n=135 Participants
Participants provide one test sample at study visit using the saliva test kit to detect the SARS-CoV-2 virus.
|
Positive Saliva Collection
n=9 Participants
Participants provide one saliva sample confirmed positive for SARS-CoV-2 virus used in lab to validate device function.
|
Negative Saliva Collection
n=3 Participants
Participants provide one saliva sample confirmed negative for SARS-CoV-2 virus used in lab to validate device function.
|
Total
n=353 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.8 years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 20.6 • n=7 Participants
|
52.6 years
STANDARD_DEVIATION 17.0 • n=5 Participants
|
23.8 years
STANDARD_DEVIATION 5.1 • n=4 Participants
|
24.3 years
STANDARD_DEVIATION 5.51 • n=21 Participants
|
46.11 years
STANDARD_DEVIATION 4.65 • n=8 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
217 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
136 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
53 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
293 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
64 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
60 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
234 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
94 participants
n=5 Participants
|
112 participants
n=7 Participants
|
135 participants
n=5 Participants
|
9 participants
n=4 Participants
|
3 participants
n=21 Participants
|
353 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 5 days per participantPopulation: Data were collected from the Saliva Test - First, Second, and Third Distribution groups only. Participants who completed at least one test are included in the analysis.
Feasibility Outcome. Discrepancy in interpretation of colormetric readout by participant versus by technician via photo. Passed test = void of manufacturing or user error.
Outcome measures
| Measure |
Saliva Test - First Distribution
n=78 Completed tests
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
|
Saliva Test - Second Distribution
n=121 Completed tests
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
|
Saliva Test - Third Distribution
n=131 Completed tests
Participants provide one test sample at study visit using the saliva test kit to detect the SARS-CoV-2 virus.
|
|---|---|---|---|
|
Number of Matched Test Colormetric Interpretation as a Measure of Interrater Reliability
Total passed tests
|
52 Completed tests
|
69 Completed tests
|
97 Completed tests
|
|
Number of Matched Test Colormetric Interpretation as a Measure of Interrater Reliability
Matching interpretation
|
27 Completed tests
|
67 Completed tests
|
93 Completed tests
|
PRIMARY outcome
Timeframe: Up to 5 days per participantPopulation: Data were collected from the Saliva Test - First, Second, and Third Distribution groups only. Participants who completed at least one test are included in the analysis.
Validity Outcome.
Outcome measures
| Measure |
Saliva Test - First Distribution
n=78 Completed tests
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
|
Saliva Test - Second Distribution
n=121 Completed tests
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
|
Saliva Test - Third Distribution
n=131 Completed tests
Participants provide one test sample at study visit using the saliva test kit to detect the SARS-CoV-2 virus.
|
|---|---|---|---|
|
Number of Positive Home Saliva Tests as Determined by the Patient
|
NA Completed tests
Data were not analyzable for this outcome because reagents were not stable over the course of a day and the dye used was too sensitive to pH, leading to unreliable data.
|
NA Completed tests
Data were not analyzable for this outcome because reagents were not stable over the course of a day and the dye used was too sensitive to pH, leading to unreliable data.
|
NA Completed tests
Data were not analyzable for this outcome because reagents were not stable over the course of a day and the dye used was too sensitive to pH, leading to unreliable data.
|
SECONDARY outcome
Timeframe: Up to 5 days per participantPopulation: Data were collected for the Third Distribution group only; participants who completed the test are included in the analysis
Validity Outcome (ease of interpretation). Number of participants responding by category when asked to provide a rating on being "Confident in Interpreting Results."
Outcome measures
| Measure |
Saliva Test - First Distribution
n=131 Participants
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
|
Saliva Test - Second Distribution
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
|
Saliva Test - Third Distribution
Participants provide one test sample at study visit using the saliva test kit to detect the SARS-CoV-2 virus.
|
|---|---|---|---|
|
Participant-rated Confidence in Interpreting Results
Strongly agree
|
53 Participants
|
—
|
—
|
|
Participant-rated Confidence in Interpreting Results
Agree
|
61 Participants
|
—
|
—
|
|
Participant-rated Confidence in Interpreting Results
Somewhat agree
|
9 Participants
|
—
|
—
|
|
Participant-rated Confidence in Interpreting Results
Neither agree nor disagree
|
2 Participants
|
—
|
—
|
|
Participant-rated Confidence in Interpreting Results
Somewhat disagree
|
3 Participants
|
—
|
—
|
|
Participant-rated Confidence in Interpreting Results
Disagree
|
3 Participants
|
—
|
—
|
|
Participant-rated Confidence in Interpreting Results
Strongly disagree
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 days per participantPopulation: Data were collected for the First, Second, and Third distribution groups only; participants who completed the test and responded to the survey question are included in the analysis
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."
Outcome measures
| Measure |
Saliva Test - First Distribution
n=29 Participants
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
|
Saliva Test - Second Distribution
n=64 Participants
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
|
Saliva Test - Third Distribution
n=131 Participants
Participants provide one test sample at study visit using the saliva test kit to detect the SARS-CoV-2 virus.
|
|---|---|---|---|
|
Participant-rated Ease of Use
Strongly agree
|
0 Participants
|
5 Participants
|
13 Participants
|
|
Participant-rated Ease of Use
Agree
|
6 Participants
|
22 Participants
|
52 Participants
|
|
Participant-rated Ease of Use
Somewhat agree
|
7 Participants
|
10 Participants
|
39 Participants
|
|
Participant-rated Ease of Use
Neither agree nor disagree
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Participant-rated Ease of Use
Somewhat disagree
|
8 Participants
|
12 Participants
|
18 Participants
|
|
Participant-rated Ease of Use
Disagree
|
3 Participants
|
6 Participants
|
5 Participants
|
|
Participant-rated Ease of Use
Strongly disagree
|
3 Participants
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 5 days per participantPopulation: Data were collected for this outcome from the Saliva Test - First and Second distribution groups only.
Feasibility Outcome (ease of use). Number of participants that called technical support, by reason (e.g., processing was not possible due to broken part).
Outcome measures
| Measure |
Saliva Test - First Distribution
n=94 Participants
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
|
Saliva Test - Second Distribution
n=112 Participants
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
|
Saliva Test - Third Distribution
Participants provide one test sample at study visit using the saliva test kit to detect the SARS-CoV-2 virus.
|
|---|---|---|---|
|
Number of Participants That Called Technical Support
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 5 days per participantPopulation: Data were collected from the Saliva Test - First and Third distribution groups only. Participants who completed at least one test are included in the analysis.
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.
Outcome measures
| Measure |
Saliva Test - First Distribution
n=78 Test samples
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
|
Saliva Test - Second Distribution
n=131 Test samples
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
|
Saliva Test - Third Distribution
Participants provide one test sample at study visit using the saliva test kit to detect the SARS-CoV-2 virus.
|
|---|---|---|---|
|
Sample Integrity
Sufficient sample
|
78 Test samples
|
131 Test samples
|
—
|
|
Sample Integrity
Significant presence of bubbles
|
25 Test samples
|
50 Test samples
|
—
|
SECONDARY outcome
Timeframe: Up to 5 days per participantPopulation: Data were collected from the Validation Saliva Samples group only.
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.
Outcome measures
| Measure |
Saliva Test - First Distribution
n=5 Positive tests run
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
|
Saliva Test - Second Distribution
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
|
Saliva Test - Third Distribution
Participants provide one test sample at study visit using the saliva test kit to detect the SARS-CoV-2 virus.
|
|---|---|---|---|
|
Sensitivity of Sample Test Kit
|
4 Positive tests run
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 days per participantPopulation: Specificity analysis includes samples confirmed negative from the First or Second Distribution groups, and samples from the Negative Saliva Collection group only
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.
Outcome measures
| Measure |
Saliva Test - First Distribution
n=18 Negative tests run
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
|
Saliva Test - Second Distribution
n=10 Negative tests run
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
|
Saliva Test - Third Distribution
n=28 Negative tests run
Participants provide one test sample at study visit using the saliva test kit to detect the SARS-CoV-2 virus.
|
|---|---|---|---|
|
Specificity of Sample Test Kit
|
15 Negative tests run
|
10 Negative tests run
|
25 Negative tests run
|
Adverse Events
Saliva Test - First Distribution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saliva Test - Second Distribution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saliva Test - Third Distribution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Positive Saliva Collection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Negative Saliva Collection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place