Clinical Performance of Capillary Blood Samples Collected Using the Tasso+ Serum Gel Capillary Blood Collection System for Clinical Chemistry Testing of 14 Analytes on an Abbott Alinity Analyzer

NCT07260799 | Recruiting FDA Device

• 1 other identifier: T23-03
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this single-visit study is to demonstrate the performance of capillary blood samples collected with the Tasso+ Serum Gel Capillary Blood Collection System compared to venous reference samples for downstream analyte testing at a clinical laboratory.

Conditions

Serum Analytes

Outcome Measures

Primary Outcomes (1)

• Number participants for which there is statistical equivalence between serum biomarker results obtained from capillary blood vs. venous blood

  48 Hours

Study Arms (1)

Tasso+ Serum Gel Capillary Blood Collection System

Comparison of serum analyte results from capillary blood collected using the Tasso+ Serum Gel Capillary Blood Collection System vs. venous blood obtained via traditional venipuncture.

Diagnostic Test: Tasso+ Serum Gel Capillary Blood Collection System

Interventions

Tasso+ Serum Gel Capillary Blood Collection System DIAGNOSTIC_TEST

Clinical evaluation of capillary blood samples collected using the Tasso+ Serum Gel Capillary Blood Collection System for downstream analyte testing.

Tasso+ Serum Gel Capillary Blood Collection System

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy individuals or patients with abnormal analyte values (verified or likely to be) within intended clinical reference ranges as indicated by standard of care testing and/or past medical history.

You may qualify if:

• Adults aged 18-85 years with no previous experience with the Tasso+ lancet
• Willing and able to provide written informed consent prior to study entry
• Willing and able to adhere to study assessments, schedule, prohibitions and restrictions as described in the protocol
• Healthy individuals or patients with abnormal analyte values (verified or likely to be) within intended clinical reference ranges as indicated by standard of care testing and/or past medical history, in the judgement of the investigator

You may not qualify if:

• Present with abnormal skin integrity or atypical skin health near/on arm collection sites
• Mental or physical impairment which would preclude participation in the judgement of the investigator or qualified designee
• Trained clinical laboratory and healthcare personnel who have worked in the field in the previous 5 years
• 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)

Sponsors & Collaborators

• Tasso Inc.: lead
• American Research Labs: collaborator

Study Sites (1)

Celesta / American Research Labs

Atlantis, Florida, 33462, United States

RECRUITING

Central Study Contacts

DEMA POPPA, MS

CONTACT

(206) 822-4186; info@tassoinc.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: October 25, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)