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Active, Not Recruiting

NCT Number: NCT07260799

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Celesta / American Research Labs, Atlantis, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 48 Hours

Sponsors and collaborators

Lead sponsor

Tasso Inc.

Industry

Collaborators

  • American Research Labs

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 3, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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