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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07260799

Enrollment

150

Registered

2025-12-03

Start date

2025-10-25

Completion date

2026-10-31

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Serum Analytes

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.

Interventions

DIAGNOSTIC_TESTTasso+ 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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026