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Active, not recruitingNCT07260799Updated Jul 20, 2026

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

An observational study in Serum Analytes, sponsored by Tasso Inc.. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by Tasso Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Serum Analytes
03

In context

Lead sponsor

Tasso Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
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.

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

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)
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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.

06

What researchers measure

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

07

Study locations

2 sites
  • Celesta / American Research Labs
    Atlantis, Florida 33462, United States
  • Tasso, Inc.
    Seattle, Washington 98119, United States
08

References and documents

Individual participant data

Plan to share: No — Research results are proprietary; no sharing with other researchers is anticipated.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07260799
Lead sponsor
Tasso Inc.
Collaborators
American Research Labs
Responsible party
Sponsor
First posted
Dec 3, 2025
Start date
Oct 25, 2025
Primary completion
Oct 31, 2026 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
Jul 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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