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| Name | Class |
|---|---|
| BioBox | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saliva test | Experimental | Participants perform each test assay, noting the results for comparison by technician, and completing survey questionnaires. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saliva test kit | Device | Kit including tube with closed reagents using loop-mediated isothermal amplification (LAMP) assay to detect SARS-CoV-2 virus. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Matched Test Colormetric Interpretation as a Measure of Interrater Reliability | Feasibility Outcome. Discrepancy in interpretation of colormetric readout by participant versus by technician via photo. Passed test = void of manufacturing or user error. | Up to 5 days per participant |
| Number of Positive Home Saliva Tests as Determined by the Patient | Validity Outcome. | Up to 5 days per participant |
| Measure | Description | Time Frame |
|---|---|---|
| Participant-rated Confidence in Interpreting Results | Validity Outcome (ease of interpretation). Number of participants responding by category when asked to provide a rating on being "Confident in Interpreting Results." | Up to 5 days per participant |
| Participant-rated Ease of Use |
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Inclusion Criteria:
Hospitalized patients
High-risk/positive population
Low-risk population
Exclusion Criteria:
All participants:
High-risk/positive population
Low-risk population
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| Name | Affiliation | Role |
|---|---|---|
| Manu Prakash, PhD | Stanford University | Principal Investigator |
| Manisha Desai, PhD | Stanford University | Principal Investigator |
| Euan A Ashley, MRCP, DPhil | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SHC Valley Care | Pleasanton | California | 94566 | United States | ||
| Stanford University |
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| Label | URL |
|---|---|
| https://www.snapdx.org/ (for more information and how to enroll) | View source |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Saliva Test - First Distribution | Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus. |
| FG001 | Saliva Test - Second Distribution | Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus. |
| FG002 | Saliva Test - Third Distribution | Participants provide one test sample at study visit using the saliva test kit to detect the SARS-CoV-2 virus. |
| FG003 | Positive Saliva Collection | Participants provide one saliva sample confirmed positive for SARS-CoV-2 virus used in lab to validate device function. |
| FG004 | Negative Saliva Collection | Participants provide one saliva sample confirmed negative for SARS-CoV-2 virus used in lab to validate device function. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Saliva Test - First Distribution | Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus. |
| BG001 | Saliva Test - Second Distribution |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Matched Test Colormetric Interpretation as a Measure of Interrater Reliability | Feasibility Outcome. Discrepancy in interpretation of colormetric readout by participant versus by technician via photo. Passed test = void of manufacturing or user error. | 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. | Posted | Count of Units | Completed tests | No | Up to 5 days per participant | Completed tests | Completed tests |
|
Average approximately 1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Saliva Test - First Distribution | Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manu Prakash, PhD | Stanford University BioEngineering | (650) 725-3731 | manup@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 23, 2021 | Nov 17, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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
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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." |
| Up to 5 days per participant |
| Number of Participants That Called Technical Support | Feasibility Outcome (ease of use). Number of participants that called technical support, by reason (e.g., processing was not possible due to broken part). | Up to 5 days per participant |
| Sample Integrity | 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. | Up to 5 days per participant |
| Sensitivity of Sample Test Kit | 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. | Up to 5 days per participant |
| Specificity of Sample Test Kit | 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. | Up to 5 days per participant |
| Stanford |
| California |
| 94305 |
| United States |
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.
| BG002 | Saliva Test - Third Distribution | Participants provide one test sample at study visit using the saliva test kit to detect the SARS-CoV-2 virus. |
| BG003 | Positive Saliva Collection | Participants provide one saliva sample confirmed positive for SARS-CoV-2 virus used in lab to validate device function. |
| BG004 | Negative Saliva Collection | Participants provide one saliva sample confirmed negative for SARS-CoV-2 virus used in lab to validate device function. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race category options in patient-completed online survey | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus. |
| OG002 | Saliva Test - Third Distribution | Participants provide one test sample at study visit using the saliva test kit to detect the SARS-CoV-2 virus. |
|
|
| Primary | Number of Positive Home Saliva Tests as Determined by the Patient | Validity Outcome. | 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. | Posted | Count of Units | Completed tests | Up to 5 days per participant | Completed tests | Completed tests |
|
|
|
| Secondary | Participant-rated Confidence in Interpreting Results | Validity Outcome (ease of interpretation). Number of participants responding by category when asked to provide a rating on being "Confident in Interpreting Results." | Data were collected for the Third Distribution group only; participants who completed the test are included in the analysis | Posted | Count of Participants | Participants | Up to 5 days per participant |
|
|
|
| Secondary | Participant-rated Ease of Use | 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." | 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 | Posted | Count of Participants | Participants | Up to 5 days per participant |
|
|
|
| Secondary | Number of Participants That Called Technical Support | Feasibility Outcome (ease of use). Number of participants that called technical support, by reason (e.g., processing was not possible due to broken part). | Data were collected for this outcome from the Saliva Test - First and Second distribution groups only. | Posted | Count of Participants | Participants | Up to 5 days per participant |
|
|
|
| Secondary | Sample Integrity | 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. | 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. | Posted | Count of Units | Test samples | Up to 5 days per participant | Test samples | Test samples |
|
|
|
| Secondary | Sensitivity of Sample Test Kit | 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. | Data were collected from the Validation Saliva Samples group only. | Posted | Count of Units | Positive tests run | Up to 5 days per participant | Positive tests run | Positive tests run |
|
|
|
| Secondary | Specificity of Sample Test Kit | 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. | Specificity analysis includes samples confirmed negative from the First or Second Distribution groups, and samples from the Negative Saliva Collection group only | Posted | Count of Units | Negative tests run | Up to 5 days per participant | Negative tests run | Negative tests run |
|
|
|
| 0 |
| 94 |
| 0 |
| 94 |
| 0 |
| 94 |
| EG001 | Saliva Test - Second Distribution | Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus. | 0 | 112 | 0 | 112 | 0 | 112 |
| EG002 | Saliva Test - Third Distribution | Participants provide one test sample at study visit using the saliva test kit to detect the SARS-CoV-2 virus. | 0 | 135 | 0 | 135 | 0 | 135 |
| EG003 | Positive Saliva Collection | Participants provide one saliva sample confirmed positive for SARS-CoV-2 virus used in lab to validate device function. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG004 | Negative Saliva Collection | Participants provide one saliva sample confirmed negative for SARS-CoV-2 virus used in lab to validate device function. | 0 | 3 | 0 | 3 | 0 | 3 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Title | Measurements |
|---|---|
|
| Neither agree nor disagree |
|
| Somewhat disagree |
|
| Disagree |
|
| Strongly disagree |
|
| Title | Measurements |
|---|---|
|
| Somewhat agree |
|
| Neither agree nor disagree |
|
| Somewhat disagree |
|
| Disagree |
|
| Strongly disagree |
|