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

Novartis

Status: Completed

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

Treatments: Device: Blood test

Study type: Interventional

Funder types: Industry

Identifiers

NCT00552214

ULT-001-TW1-Amendment 1.1

Details and patient eligibility

About

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.

Enrollment: 10,290 patients

Sex: All

Ages: 17 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10,290 participants in 1 patient group

Human Blood Donor Plasma Specimens

Other group

Treatment:

Device: Blood test