A Multi-site Clinical Evaluation of Capillary Blood Samples Collected Using the Tasso+SST Device for Downstream Analyte Testing

A Multi-site Clinical Evaluation of Capillary Blood Samples Collected Using the Tasso+SST Device for Downstream Analyte Testing.

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 Overview

• Status: Completed
• Conditions: Serum Analytes
• Intervention / Treatment: Diagnostic test: Tasso+SST

• Study Type: Observational
• Enrollment (Actual): 443

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98119
      • Tasso Research Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Adults aged 18 - 85 years
2. Willing and able to provide written informed consent prior to study entry
3. Willing and able to adhere to study assessments, schedule, prohibitions and restrictions as described in the protocol
4. 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 (which may be documented or self-reported)

Exclusion Criteria:

1. Present with abnormal skin integrity or atypical skin health near/on arm collection sites
2. Mental or physical impairment which would preclude participation in the judgement of the investigator or qualified designee
3. Laboratory and healthcare personnel.
4. Any condition which, in the opinion of the Investigator or delegate, makes the participant unsuitable for this study (including, but not limited to, any mental or physical impairment which would preclude provision of adequate and knowledgeable consent)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Comparison of capillary blood collected with a Tasso+ lancet vs. venous blood obtained via venipuncture - Platform 1, two visit schedule.	Diagnostic test: Tasso+SST; Clinical evaluation of capillary blood samples collected using the Tasso+SST device for downstream analyte testing.
Cohort 2; Comparison of capillary blood collected with a Tasso+ lancet vs. venous blood obtained via venipuncture - Platform 2, one visit schedule	Diagnostic test: Tasso+SST; Clinical evaluation of capillary blood samples collected using the Tasso+SST device for downstream analyte testing.
Cohort 3; Comparison of capillary blood collected with a Tasso+ lancet vs. venous blood obtained via venipuncture - Platform 1, one visit schedule	Diagnostic test: Tasso+SST; Clinical evaluation of capillary blood samples collected using the Tasso+SST device for downstream analyte testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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 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
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	2 Weeks

Collaborators and Investigators

• Sponsor: Tasso Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2024
• Primary Completion (Actual): April 15, 2025
• Study Completion (Actual): April 15, 2025

Study Registration Dates

• First Submitted: April 7, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: T23-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Research results are proprietary; no sharing with other researchers is anticipated.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No