Evaluation of HIV-1, HCV and HBV Blood Screening Tests With Human Blood Donor Specimens

This study is enrolling participants by invitation only.
Information provided by:
ClinicalTrials.gov Identifier:
First received: October 30, 2007
Last updated: November 5, 2007
Last verified: October 2007
The purpose of this study is to validate the performance characteristics of an assay that tests for HIV-1, HCV and HBV on an automated blood bank instrument for registration submission.

Device: Blood test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of a TMA Assay for the Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Sensitivity and Specificity [ Time Frame: 01 August 2007 to 31 December 2007 ]

Estimated Enrollment: 10500
Study Start Date: August 2007
Intervention Details:
    Device: Blood test
    Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens

Ages Eligible for Study:   17 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • An acceptable blood donation health history and an EIA negative donation sample result with licensed EIA procedures in routine use at each facility

Exclusion Criteria:

  • A positive (reactive) HIV and/or HCV and/or HBV test
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552214

Taipei Blood Center Taiwan Blood Service Foundation (TBSF)
3 Fl. No. 3 Han-Hai Road, Taipei 100, Taiwan
Sponsors and Collaborators
Study Director: Judith Blunt Novartis
  More Information

ClinicalTrials.gov Identifier: NCT00552214     History of Changes
Other Study ID Numbers: ULT-001-TW1-Amendment 1.1 
Study First Received: October 30, 2007
Last Updated: November 5, 2007

Keywords provided by Novartis:
Nucleic acid test
HIV Seronegativity

ClinicalTrials.gov processed this record on January 19, 2017