Evaluation of a Human Immunodeficiency Virus (HIV) Blood Screening Assay
NCT ID: NCT00686205
Last Updated: 2011-12-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
24111 participants
INTERVENTIONAL
2007-08-31
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SCREENING
NONE
Study Groups
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ABBOTT PRISM HIV O Plus assay for Specificity
All subjects will have their blood tested by the investigational HIV test.
collection of follow-up sample based on PRISM HIV O Plus result
Test blood samples with investigational HIV assay. If results are reactive, donors may be deferred and asked to return for a follow-up blood draw.
ABBOTT PRISM HIV O Plus Assay for Sensitivity
Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
No interventions assigned to this group
Interventions
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collection of follow-up sample based on PRISM HIV O Plus result
Test blood samples with investigational HIV assay. If results are reactive, donors may be deferred and asked to return for a follow-up blood draw.
Eligibility Criteria
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Inclusion Criteria
17 Years
ALL
Yes
Sponsors
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Abbott Diagnostics Division
INDUSTRY
Responsible Party
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Locations
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Mississippi Valley Regional Blood Center
Davenport, Iowa, United States
Community Blood Center of Greater Kansas City
Kansas City, Missouri, United States
Community Blood Center
Dayton, Ohio, United States
American Red Cross
Philadelphia, Pennsylvania, United States
Interstate Blood Bank, Inc.
Memphis, Tennessee, United States
South Texas Blood And Tissue Center
San Antonio, Texas, United States
Puget Sound Blood Center
Renton, Washington, United States
Countries
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Other Identifiers
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7B5-02-05R05
Identifier Type: -
Identifier Source: org_study_id