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

Tasso Inc.

Status: Enrolling

Conditions: Serum Analytes

Treatments: Diagnostic Test: Tasso+ Serum Gel Capillary Blood Collection System

Study type: Observational

Funder types: Industry

Identifiers

NCT07260799

T23-03

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

150 participants in 1 patient group

Tasso+ Serum Gel Capillary Blood Collection System

Description:

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.

Treatment:

Diagnostic Test: Tasso+ Serum Gel Capillary Blood Collection System