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
Study Type
OBSERVATIONAL
Enrollment
443
Clinical evaluation of capillary blood samples collected using the Tasso+SST device for downstream analyte testing.
Tasso Research Clinic
Seattle, Washington, United States
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.
Time frame: 2 Weeks
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
Time frame: 1 Day
Number of observed device usability issues observed in lay users and HCP populations, i.e., deviations from the instructions for use.
To demonstrate usability of the Tasso+SST device in naive lay users and in trained HCP populations
Time frame: 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
Time frame: 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
Time frame: 2 Weeks
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