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
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
- Serum Analytes
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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
- 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
| Arm | Description | Assigned 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. |
|
Recruiting Locations
Celesta / American Research Labs
Atlantis, Florida 33462
Atlantis, Florida 33462
More Details
- Status
- Recruiting
- Sponsor
- Tasso Inc.