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

Novartis10,290 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

10,290

Conditions

Screening for the Presence of HIV-1, RNA and HBV DNA in Blood Donations

Interventions

Blood testDEVICE

Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens

Eligibility

Sex: ALLMin age: 17 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Taipei Blood Center Taiwan Blood Service Foundation (TBSF)

Taipei, Taiwan

Outcomes

Primary Outcomes

Sensitivity and Specificity

Time frame: 01 August 2007 to 31 December 2007

Data from ClinicalTrials.gov

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