RecruitingNot Applicable

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

United States150 participantsStarted 2025-10-25

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. Adults aged 18-85 years with no previous experience with the Tasso+ lancet
✓. Willing and able to provide written informed consent prior to study entry
✓. Willing and able to adhere to study assessments, schedule, prohibitions and restrictions as described in the protocol
✓. 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
✕. Mental or physical impairment which would preclude participation in the judgement of the investigator or qualified designee
✕. Trained clinical laboratory and healthcare personnel who have worked in the field in the previous 5 years
✕. 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)

What they're measuring

Number participants for which there is statistical equivalence between serum biomarker results obtained from capillary blood vs. venous blood

Timeframe: 48 Hours

Trial details

NCT IDNCT07260799

SponsorTasso Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-05-31

Contact for this trial

DEMA POPPA, MS

(206) 822-4186 info@tassoinc.com

View on ClinicalTrials.gov More Serum Analytes trials