Evaluation of a Human Immunodeficiency Virus (HIV) Blood Screening Assay

NCT ID: NCT00686205

Last Updated: 2011-12-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

24111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-08-31

Brief Summary

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To test blood samples from volunteer donors of whole blood and blood components using a new investigational test that detects human immunodeficiency virus (HIV) infection. Results will be compared to the current HIV screening assay.

Detailed Description

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Conditions

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Healthy Donors HIV Positive

Keywords

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healthy donors HIV positives

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

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.

Group Type EXPERIMENTAL

collection of follow-up sample based on PRISM HIV O Plus result

Intervention Type DEVICE

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.

Group Type NO_INTERVENTION

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy donors that have consented to study
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Diagnostics Division

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mississippi Valley Regional Blood Center

Davenport, Iowa, United States

Site Status

Community Blood Center of Greater Kansas City

Kansas City, Missouri, United States

Site Status

Community Blood Center

Dayton, Ohio, United States

Site Status

American Red Cross

Philadelphia, Pennsylvania, United States

Site Status

Interstate Blood Bank, Inc.

Memphis, Tennessee, United States

Site Status

South Texas Blood And Tissue Center

San Antonio, Texas, United States

Site Status

Puget Sound Blood Center

Renton, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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7B5-02-05R05

Identifier Type: -

Identifier Source: org_study_id