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

Conditions

• Blood Self-Collection for Clinical Diagnostic Assessments

Eligibility Criteria

Sex

ALL

Age

13 Years - N/A

Healthy Volunteers

Accepted

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).
• 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.

Study Details

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.

Key Dates

Start date

Jul 25, 2023

Status verified

Aug 2025

Primary completion

Jul 31, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

2,500 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• Other: Human Blood Specimen Collection
  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.

Primary Outcome Measure

Venous and Tasso+ blood sample correlation for biomarkers being tested. [ Time Frame: 1 Year ]

Central Contacts

• Sri Bharat Madireddy, Ph.D.
  5616504699
  [email protected]
• Vanaja Reddy Bodeddula, Ph.D.
  5619030806
  [email protected]

Locations (1)

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