NCT05852925 · American Research Labs
Evaluation of Tasso+ Blood Self-Collection for Clinical Diagnostic Assessment of Various Biomarkers
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
Venous and Tasso+ blood sample correlation for biomarkers being tested.
Time frame: 1 Year
Correlation between the venous blood sample with the Tasso+ blood sample for the biomarkers listed in the study description. The biomarkers are quantified or qualitatively measured using either Abbott Alinity ci-series, Siemens Dimension EXL, Siemens Immulite 2000 xpi, Dynex DSX Automated Elisa System, or an equivalent analyzer. Note: A biomarker collected from both venipuncture and Tasso+ methods will be analyzed using the same analyzer to avoid any bias that may arise from using different instruments
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- To participate in this study, an individual must meet all the following criteria:
- Age: Participants must be 13 years of age or older.
- Medical history: There may be no specific medical history requirements for inclusion, although participants may need to meet certain general health criteria.
- Sample type: Participants must be willing and able to provide the human specimens needed for the study, such as blood, urine, or saliva.
- 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.
- 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:
- 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.
- 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.
- Educationally disadvantaged: Participants who lack the education or literacy skills required to understand the study procedures or provide informed consent.
- 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.
- Prisoners: Participants who are incarcerated in correctional facilities, as their participation may raise ethical concerns or require additional regulatory approvals.
- 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
- Atlantis, Florida
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 29, 2025 · Source of record for eligibility and locations