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This is a prospective, multi-center study within the U.S. Study participants will take part in two study visits a minimum of 14 days apart. During each visit, participants will self-collect capillary blood samples. Additionally, a healthcare provide will obtain capillary and venous serum samples. All capillary samples will be collected from the upper arm using the Tasso+ device paired with a commercially-available serum separator gel microtainer. The samples will be shipped to a clinical laboratory and tested for various analytes. Expected analyte values for each participant will be based on their venous sample results which will be compared to Tasso sample results
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Comparison of capillary blood collected with a Tasso+ lancet vs. venous blood obtained via venipuncture - Platform 1, two visit schedule. |
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| Cohort 2 | Comparison of capillary blood collected with a Tasso+ lancet vs. venous blood obtained via venipuncture - Platform 2, one visit schedule |
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| Cohort 3 | Comparison of capillary blood collected with a Tasso+ lancet vs. venous blood obtained via venipuncture - Platform 1, one visit schedule |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tasso+SST | Diagnostic Test | Clinical evaluation of capillary blood samples collected using the Tasso+SST device for downstream analyte testing. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number participants for which there is statistical concordance between serum biomarker results obtained from capillary blood vs. venous blood | To establish the clinical performance of the Tasso+SST device for lay user self-collection and for trained healthcare provider (HCP) collection of capillary blood samples for downstream analyte testing at a clinical laboratory. | 2 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of lay users in a simulated home setting for with statistical concordance between serum biomarker results obtained from capillary blood vs. venous blood | To evaluate the performance of Tasso+SST capillary samples collected by lay users in a simulated home environment | 1 Day |
| Number of observed device usability issues observed in lay users and HCP populations, i.e., deviations from the instructions for use. |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy individuals or patients with analyte values (verified or likely to be) within intended clinical reference ranges as indicated by standard of care testing and/or past medical history
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tasso Research Clinic | Seattle | Washington | 98119 | United States |
Research results are proprietary; no sharing with other researchers is anticipated.
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Serum obtained from whole blood
To demonstrate usability of the Tasso+SST device in naive lay users and in trained HCP populations |
| 2 Weeks |
| Number participants for which there is statistical concordance between serum biomarker results obtained from Tasso+ capillary blood by two different HCPs | To demonstrate HCP inter-operator precision of Tasso+SST samples | 2 weeks |
| Number participants for which there is statistical concordance between serum biomarker results obtained from Tasso+ capillary blood by the same lay user | To demonstrate lay user intra-operator precision of Tasso+SST samples | 2 Weeks |