Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Purpose and objective: The purpose of this pilot study is participant user acceptance testing of the Tasso-SST OnDemand device to collect blood for antibody testing. The study will also compare antibody testing results from blood collected using the Tasso-SST OnDemand device compared to blood collected by phlebotomy.
Study activities and population group: All participants enrolled in the MURDOCK C3PI Study (Pro Pro00105703), and actively participating in the testing cohort (n=300), will be emailed about the study. One or more reminder emails may be sent. The study seeks to enroll up to 100 participants.
Participants will collect blood using the Tasso-SST OnDemand at the same visit where blood will be collected via phlebotomy for the MURDOCK C3PI study. Blood samples will be spun and processed for serum, which will be shipped frozen to analytical lab at Duke. Participants will complete a short survey about their experience using the Tasso-SST OnDemand device.
Data analysis and risk/safety issues: The study team will evaluate correlation between results from blood collected by the two methods and qualitatively exam participant survey results. There are no risk/safety issues. Risk of reaction at the collection site is similar to that of phlebotomy and is described in the electronic consent form.
Purpose: The purpose of this pilot study is participant user acceptance testing of the Tasso-SST OnDemand device to collect blood for antibody testing. The study will also compare antibody testing results from blood collected using the Tasso-SST On-Demand device compared to blood collected by phlebotomy.
Design and Procedure: Participants will collect a small blood sample using the Tasso-SST OnDemand device during a serology blood draw visit already scheduled for the MURDOCK C3PI Study (Pro00105703). Participants will be provided a kit that includes written, step-by-step instructions that include pictures. Participants will also have the option to watch a brief video on using the device, available online, prior to collection. The Tasso-SST OnDemand device collects whole capillary blood, at a minimum volume of 80ul.
A standard blood draw will also be done and both blood samples will be spun and processed for serum. Serum will be frozen and shipped to the lab at Duke for antibody testing. Antibody results will be compared between the two methods.
Participants will be sent a brief survey to learn about their experience using the Tasso-SST OnDemand device.
Selection of Subject:
Subject Recruitment: All participants meeting eligibility criteria will be emailed about the study. One or more reminder emails may be sent about the study. The study seeks to enroll up to 100 participants.
The Tasso-SST OnDemand device sticks to the skin with a light adhesive. When the button is pressed, a vacuum forms and a lancet pricks the surface of the skin. The vacuum draws blood out of the capillaries and into a tube attached to the bottom of the device. The Investigator Brochure is attached to this submission.
Risk and Benefit Assessment: The Tasso-SST OnDemand device uses an adhesive - the device should be removed immediately if there are any signs of an allergic reaction. There is risk of bruising or soreness at the site where blood is drawn. There is also a slight possibility of infection, and a rare risk of fainting.
Participants can minimize risk by closely following the instructions provided with the kits.
Trained staff will be present should the participant have any concerns or issues.
The study does not have a direct benefit to participants. The information learned could lead to future use of the Tasso-SST OnDemand device to collect blood safely at home.
Data Analysis and Data Safety Monitoring: The study team will evaluate correlation between results from blood collected by the two methods in this pilot study and qualitatively exam participant survey results. Summary statistics will be generated for survey responses, and qualitative data will be reviewed.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tasso- SST blood collection | Other | About 100 participants will have blood collected by two methods-regular phlebotomy and Tasso-SST, in this pilot study. |
|
| Regular Venipuncture | Other | About 100 participants will have blood collected by two methods-regular phlebotomy and Tasso-SST, in this pilot study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tasso-SST on Demand | Device | Participants will collect a small blood sample using the Tasso-SST OnDemand device during a serology blood draw visit already scheduled for the MURDOCK C3PI Study (Pro00105703). Participants will be provided a kit that includes written, step-by-step instructions that include pictures. Participants will also have the option to watch a brief video on using the device, available online, prior to collection. Both blood samples will be spun and processed for serum. Serum will be frozen and shipped to the lab at Duke for antibody testing. Antibody results will be compared between the two methods. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity is Calculated as the Percentage of the Abbott Alinity Nucleocapsid IgG Antibody Assay Positive Cases Testing Positive Using TASSO-SST Collected Blood Samples. Se=N Tasso(+) / N Phlebotomy Antibody (+) Assay (+) | Sensitivity is defined as the number detected as positive on the new screen (Tasso) divided by the number defined as positive under the 'gold standard' multiplied by 100%. This is presented as a comparison to testing of blood samples obtained by routine phlebotomy as the gold standard (Abbott Alinity nucleocapsid IgG antibody assay drawn by a phlebotomist). | up to 17 days after onset of symptoms |
| Reliability of the Abbott Alinity Nucleocapsid IgG Antibody Assay Using TASSO-SST Collected Blood Samples | Interclass correlation (ICC) uses the 2 measures (Tasso & SST), measured on the same subjects. ICC is defined as the Variance between Persons (Var-P) divided by the Variance within Persons (error) Var-E. ICC is defined as Var-P/(Var-P + Var-E). confidence intervals are easily defined by incorporating sample size. Presented as the interclass correlation coefficient between TASSO-SST collected and routine phlebotomy sample results. | up to 17 days after onset of symptoms |
| Bias Between TASSO-SST Collected Blood Samples and Routine Phlebotomy Samples in the Abbott Alinity Nucleocapsid IgG Antibody Assay | Bias is measured using the Bland-Altman method. Here, the difference the values by the 2 measures (Phlebotomy-Tasso) (difference) is compared to the average of Phlebotomy & Tasso (average). Bias is defined as differences which vary from 0, and is measured by (1) assessing if the average difference is non-zero, and (2) if the difference is systematically more or less close to 0 as the average increases. Presented as the regression slope. | up to 17 days after onset of symptoms |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| L.Kristin Newby, MD, MHS | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke CTSI Translational Population Health Office | Kannapolis | North Carolina | 28081 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TASSO-SST OnDemand Blood Collection vs. Routine Phlebotomy | Compared the performance of TASSO-SST OnDemand blood collection with routine phlebotomy (gold standard) on paired samples from the same participant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who completed the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TASSO-SST OnDemand Blood Collection vs. Routine Phlebotomy | Compared the performance of TASSO-SST OnDemand blood collection with routine phlebotomy (gold standard) on paired samples from the same participant. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Sensitivity is Calculated as the Percentage of the Abbott Alinity Nucleocapsid IgG Antibody Assay Positive Cases Testing Positive Using TASSO-SST Collected Blood Samples. Se=N Tasso(+) / N Phlebotomy Antibody (+) Assay (+) | Sensitivity is defined as the number detected as positive on the new screen (Tasso) divided by the number defined as positive under the 'gold standard' multiplied by 100%. This is presented as a comparison to testing of blood samples obtained by routine phlebotomy as the gold standard (Abbott Alinity nucleocapsid IgG antibody assay drawn by a phlebotomist). | Participants who were able to draw blood using the TASSO-SST OnDemand device. | Posted | Number | percent sensitivity | up to 17 days after onset of symptoms |
|
1 day per patient.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Definition of Arm/Group | This is a single armed trial comparing 2 measures for COVID determination in a clinical sample. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Douglas Wixted | Duke Clinical and Translational Science Institute | 919-668-0515 | douglas.wixted@duke.edu |
Not provided
| 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 | Nov 23, 2021 | Mar 4, 2022 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Participants will collect a small blood sample using the Tasso-SST OnDemand device during a serology blood draw visit already scheduled for the MURDOCK C3PI Study (Pro00105703). Participants will be provided a kit that includes written, step-by-step instructions that include pictures. Participants will also have the option to watch a brief video on using the device, available online, prior to collection.
Not provided
Not provided
Not provided
Not provided
|
| Regular Phlebotomy | Other | Participants will have a small blood sample collected via regular venipuncture. |
|
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Reliability of the Abbott Alinity Nucleocapsid IgG Antibody Assay Using TASSO-SST Collected Blood Samples | Interclass correlation (ICC) uses the 2 measures (Tasso & SST), measured on the same subjects. ICC is defined as the Variance between Persons (Var-P) divided by the Variance within Persons (error) Var-E. ICC is defined as Var-P/(Var-P + Var-E). confidence intervals are easily defined by incorporating sample size. Presented as the interclass correlation coefficient between TASSO-SST collected and routine phlebotomy sample results. | Participants who were able to draw blood using the TASSO-SST OnDemand device. | Posted | Number | 95% Confidence Interval | interclass correlation coefficient | up to 17 days after onset of symptoms |
|
|
|
|
| Primary | Bias Between TASSO-SST Collected Blood Samples and Routine Phlebotomy Samples in the Abbott Alinity Nucleocapsid IgG Antibody Assay | Bias is measured using the Bland-Altman method. Here, the difference the values by the 2 measures (Phlebotomy-Tasso) (difference) is compared to the average of Phlebotomy & Tasso (average). Bias is defined as differences which vary from 0, and is measured by (1) assessing if the average difference is non-zero, and (2) if the difference is systematically more or less close to 0 as the average increases. Presented as the regression slope. | Participants who were able to draw blood using the TASSO-SST OnDemand device. | Posted | Mean | Standard Deviation | slope | up to 17 days after onset of symptoms |
|
|
|
| 0 |
| 135 |
| 0 |
| 135 |
| 0 |
| 135 |
Not provided
Not provided
Not provided