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

December 16, 2011 updated by: Abbott Diagnostics Division
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24111

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Davenport, Iowa, United States, 52807
        • Mississippi Valley Regional Blood Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Community Blood Center of Greater Kansas City
    • Ohio
      • Dayton, Ohio, United States, 45402
        • Community Blood Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19123
        • American Red Cross
    • Tennessee
      • Memphis, Tennessee, United States, 38134
        • Interstate Blood Bank, Inc.
    • Texas
      • San Antonio, Texas, United States, 78201
        • South Texas Blood and Tissue Center
    • Washington
      • Renton, Washington, United States, 98057
        • Puget Sound Blood Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy donors that have consented to study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABBOTT PRISM HIV O Plus assay for Specificity
All subjects will have their blood tested by the investigational HIV test.
Device: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PRISM HIV O Plus Test Data for Specificity
Time Frame: 12 months
Negative HIV status was determined by the results of the HIV-1/HIV-2 comparator assay and HIV-1 qualitatitve RNA.
12 months
PRISM HIV O Plus Test Data for Sensitivity
Time Frame: 12 months
Final HIV status was determined according to a supplemental testing algorithm for specimens positive by the investigational assay. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot and HIV-1 ribonucleic acid (RNA).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Diagnostics Division

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

May 21, 2008

First Submitted That Met QC Criteria

May 28, 2008

First Posted (Estimate)

May 29, 2008

Study Record Updates

Last Update Posted (Estimate)

December 28, 2011

Last Update Submitted That Met QC Criteria

December 16, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7B5-02-05R05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Positive

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe