Using Tasso+ capillary arm collection for lab tests on an Abbott Alinity analyzer

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

This project tests whether small capillary blood samples collected with the Tasso+ device give the same lab results as standard venous blood draws for adults aged 18–85.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Tasso Inc. (industry)
• Locations: 1 site (Atlantis, Florida)
• Trial ID: NCT07260799 on ClinicalTrials.gov

What this trial studies

In a single-visit observational protocol, adults provide a capillary blood sample using the Tasso+ Serum Gel Capillary Blood Collection System and a simultaneous venous reference sample. Both sample types are analyzed for 14 clinical chemistry analytes on an Abbott Alinity analyzer at a central laboratory. The paired results will be compared to determine agreement between the capillary and venous methods. Eligibility includes healthy adults or patients with expected analyte variability, and excludes those with impaired skin integrity at the collection site or other conditions making participation unsuitable.

Who should consider this trial

Good fit: Adults 18–85 who can give informed consent, have not previously used the Tasso+ lancet, and are willing to attend a single visit are ideal candidates.

Not a fit: People with damaged or atypical skin at the arm collection sites or any condition that makes capillary collection unsuitable are unlikely to benefit from this approach.

Why it matters

Potential benefit: If capillary samples match venous results, patients could get routine lab tests with a simpler, less invasive arm collection instead of standard vein draws.

How similar studies have performed: Prior validations of capillary microsampling devices have shown comparable results to venous draws for many routine chemistry tests, although performance can vary by analyte and device.

Eligibility criteria

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)

Where this trial is running

Atlantis, Florida

• Celesta / American Research Labs — Atlantis, Florida, United States (RECRUITING)

Study contacts

• Study coordinator: DEMA POPPA, MS

Conditions: Serum Analytes