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Clinical Trials/NCT00552214
NCT00552214
Completed
Not Applicable

Evaluation of a TMA Assay for the Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens

Novartis1 site in 1 country10,290 target enrollmentAugust 8, 2007
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ConditionsScreening for the Presence of HIV-1, RNA and HBV DNA in Blood Donations

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Screening for the Presence of HIV-1, RNA and HBV DNA in Blood Donations
Sponsor
Novartis
Enrollment
10290
Locations
1
Primary Endpoint
Sensitivity and Specificity
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 8, 2007
End Date
July 1, 2008
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Novartis
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Sensitivity and Specificity

Time Frame: 01 August 2007 to 31 December 2007

Study Sites (1)

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