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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Sex
All
Accepts 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)

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Celesta / American Research Labs
Atlantis, Florida 33462
Contact:
Scientific Director
561-801-5835
Info@ARLLabs.com

More Details

Status
Recruiting
Sponsor
Tasso Inc.

Study Contact

DEMA POPPA, MS
(206) 822-4186
info@tassoinc.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.