Evaluating a new blood self-collection device for diagnostic tests

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

This study is testing a new device that lets people collect their own blood samples at home to see if it works as well as traditional blood draws done in a clinic.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 2500 (estimated)
• Ages: 13 Years and up
• Sex: All
• Sponsor: American Research Labs (Industry-sponsored)
• Locations: 1 site (Atlantis, Florida)
• Trial ID: NCT05852925 on ClinicalTrials.gov

What this trial studies

This study assesses the effectiveness and reliability of the Tasso+ capillary blood self-collection device compared to traditional venipuncture for clinical diagnostic assessments of various biomarkers. Participants aged 13 and older will provide blood samples using both methods, allowing researchers to analyze and compare the results for correlation. The study aims to determine if the self-collection method can be a viable alternative to traditional blood draws, potentially improving patient convenience and accessibility.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 13 years and older who are willing and able to provide blood samples.

Not a fit: Patients with specific medical conditions that prevent them from providing blood samples or those unable to understand the study materials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more convenient and less invasive method for patients to collect blood samples for diagnostic testing.

How similar studies have performed: While the concept of self-collection devices is gaining traction, this specific approach using the Tasso+ device is relatively novel and has not been extensively tested in similar studies.

Eligibility criteria

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.

Where this trial is running

Atlantis, Florida

• American Research Labs — Atlantis, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Sri Bharat Madireddy, Ph.D. — American Research Labs
• Study coordinator: Sri Bharat Madireddy, Ph.D.

Conditions Blood Self-Collection for Clinical Diagnostic Assessments