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RECRUITING

NCT05852925

Evaluation of Tasso+ Blood Self-Collection for Clinical Diagnostic Assessment of Various Biomarkers

Sponsor: American Research Labs

View on ClinicalTrials.gov

Summary

This study aims to assess the effectiveness and reliability of the Tasso+ capillary blood self-collection device in the clinical diagnostic assessment of various biomarkers. The study will collect blood specimens using both the Tasso+ self-collection device and traditional venipuncture. The biomarker analysis results from both specimen types will be compared for correlation.

Official title: Evaluation of Tasso+ Capillary Blood Self-Collection for Clinical Diagnostic Assessment of Various Biomarkers

Key Details

Gender

All

Age Range

13 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2500

Start Date

2023-07-25

Completion Date

2026-07

Last Updated

2025-08-29

Healthy Volunteers

Yes

Conditions

Blood Self-Collection for Clinical Diagnostic Assessments

Interventions

OTHER

Traditional Venipuncture

Traditional blood collection is performed and the necessary amount of blood is collected into the collection tubes (either SST or Lithium Heparin tubes based on the biomarker being tested).

DEVICE

Tasso+

The Tasso+ is the blood self-collection device used in the study and this device enables the collection of microliter capillary whole blood samples into compatible reservoirs. In this study, the reservoirs utilized include either SST or Lithium Heparin microtainers based on the biomarker being tested.

Inclusion Criteria: To participate in this study, an individual must meet all the following criteria: 1. Age: Participants must be 13 years of age or older. 2. Medical history: There may be no specific medical history requirements for inclusion, although participants may need to meet certain general health criteria. 3. Sample type: Participants must be willing and able to provide the human specimens needed for the study, such as blood, urine, or saliva. 4. Ability to provide consent: Participants must have the ability to provide informed consent to participate in the study, either on their own behalf if they are legally able to do so, or with the consent of a parent or guardian if they are under 18 years of age. 5. Language proficiency: Participants must be able to read and understand the language used in the study materials, such as informed consent forms and instructions for specimen collection. Exclusion Criteria: Participation in this study will be excluded for individuals who meet the following criterion: 1. Blind or visually impaired: Participants who are unable to see or have significant visual impairment that would make it difficult for them to participate in the study. 2. Decisionally impaired: Participants who are unable to provide informed consent due to cognitive impairment, developmental disability, or other mental health conditions that affect decision-making capacity. 3. Educationally disadvantaged: Participants who lack the education or literacy skills required to understand the study procedures or provide informed consent. 4. Hospitalized: Participants who are currently hospitalized, as they may not be able to participate in the study due to their medical condition or limited mobility. 5. Prisoners: Participants who are incarcerated in correctional facilities, as their participation may raise ethical concerns or require additional regulatory approvals. 6. Terminally ill: Participants who have a terminal illness or life-limiting condition that may affect the study results or pose additional risks to their health. Excluding individuals with these characteristics from the study is intended to ensure their safety and well-being and to maintain the integrity of the study results.

Locations (1)

American Research Labs

Atlantis, Florida, United States