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

March 17, 2026 updated by: Tasso Inc.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Atlantis, Florida, United States, 33462
        • Recruiting
        • Celesta / American Research Labs
        • Principal Investigator:
          • Sri Madireddy, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

  1. Adults aged 18-85 years with no previous experience with the Tasso+ lancet
  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 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

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. Trained clinical laboratory and healthcare personnel who have worked in the field in the previous 5 years
  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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number participants for which there is statistical equivalence between serum biomarker results obtained from capillary blood vs. venous blood
Time Frame: 48 Hours
48 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tasso Inc.

Collaborators

American Research Labs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

November 21, 2025

First Posted (Actual)

December 3, 2025

Study Record Updates

Last Update Posted (Actual)

March 19, 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

  • T23-03

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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