Evaluation of HIV-1, HCV and HBV Blood Screening Tests With Human Blood Donor Specimens
Not Applicable
Completed
- Conditions
- Screening for the Presence of HIV-1, RNA and HBV DNA in Blood Donations
- Interventions
- Device: Blood test
- Registration Number
- NCT00552214
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10290
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Human Blood Donor Plasma Specimens Blood test -
- Primary Outcome Measures
Name Time Method Sensitivity and Specificity 01 August 2007 to 31 December 2007
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Taipei Blood Center Taiwan Blood Service Foundation (TBSF)
🇨🇳Taipei, Taiwan