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

NCT05852925 | Recruiting DMC FDA Device

• 1 other identifier: Pro00069812
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Self-Collection for Clinical Diagnostic Assessments

Outcome Measures

Primary Outcomes (1)

• Venous and Tasso+ blood sample correlation for biomarkers being tested.

  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

  1 Year

Secondary Outcomes (1)

• Collect patient experience with the Tasso+ blood collection device kit.

  1 Year

Study Arms (1)

Human Blood Specimen Collection

OTHER

Blood will be collected from each participant using two different methods: the Tasso+ device and the traditional venipuncture approach. Both collection procedures are carried out sequentially at the study site. A phlebotomist performs the traditional venipuncture and the participant collects blood using two Tasso+ devices, following provided instructions. The lab results will be analyzed to assess the correlation of biomarkers between blood samples obtained by the participant using the Tasso+ device and those collected via venipuncture.

Other: Traditional Venipuncture; Device: Tasso+

Interventions

Traditional Venipuncture OTHER

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).

Human Blood Specimen Collection

Tasso+ DEVICE

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.

Human Blood Specimen Collection

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• To participate in this study, an individual must meet all the following criteria:
• Age: Participants must be 13 years of age or older.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• American Research Labs: lead

Study Sites (1)

American Research Labs

Atlantis, Florida, 33462, United States

RECRUITING

Study Officials

• Sri Bharat Madireddy, Ph.D.

  American Research Labs

  PRINCIPAL INVESTIGATOR

• Vanaja Reddy Bodeddula, Ph.D.

  American Research Labs

  STUDY DIRECTOR

Central Study Contacts

Sri Bharat Madireddy, Ph.D.

CONTACT

5616504699; sri@celestamedical.com

Vanaja Reddy Bodeddula, Ph.D.

CONTACT

5619030806; vanaja@celestamedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is an interventional single-group model, using a single-arm design in which all participants receive the same interventions, which includes the traditional venipuncture and Tasso+ blood self-collection. Both collection procedures are performed sequentially at the study site, with a phlebotomist performing the traditional venipuncture followed by the participant collecting blood using the Tasso+ device following provided instructions independently. The lab results will be analyzed to assess the correlation of biomarkers between blood samples obtained using the Tasso+ device and those collected via venipuncture.

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: May 10, 2023
• Study Start: July 25, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)