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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00552214
First received: October 30, 2007
Last updated: November 5, 2007
Last verified: October 2007
History of Changes
  Purpose

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.


Intervention
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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   17 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

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

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

No publications provided

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
Health Authority: Taiwan: Department of Health

Keywords provided by Novartis:
Nucleic acid test
HIV-1
hepatitis
HBV
 HCV
TMA
HIV Seronegativity

ClinicalTrials.gov processed this record on June 18, 2013