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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00686205
Recruitment Status : Completed
First Posted : May 29, 2008
Results First Posted : July 5, 2010
Last Update Posted : December 28, 2011
Information provided by (Responsible Party):
Abbott Diagnostics Division

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Donors HIV Positive Device: collection of follow-up sample based on PRISM HIV O Plus result Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24111 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Study Start Date : August 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.

Primary Outcome Measures :
  1. 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.

  2. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy donors that have consented to study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00686205

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

Responsible Party: Abbott Diagnostics Division Identifier: NCT00686205     History of Changes
Other Study ID Numbers: 7B5-02-05R05
First Posted: May 29, 2008    Key Record Dates
Results First Posted: July 5, 2010
Last Update Posted: December 28, 2011
Last Verified: December 2011

Keywords provided by Abbott Diagnostics Division:
healthy donors
HIV positives

Additional relevant MeSH terms:
HIV Seropositivity
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases