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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Diagnostics Division
ClinicalTrials.gov Identifier:
NCT00686205
First received: May 21, 2008
Last updated: December 16, 2011
Last verified: December 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening

Resource links provided by NLM:


Further study details as provided by Abbott Diagnostics Division:

Primary Outcome Measures:
  • PRISM HIV O Plus Test Data for Specificity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Negative HIV status was determined by the results of the HIV-1/HIV-2 comparator assay and HIV-1 qualitatitve RNA.

  • PRISM HIV O Plus Test Data for Sensitivity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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).


Enrollment: 24111
Study Start Date: August 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy donors that have consented to study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686205

Locations
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
  More Information

No publications provided

Responsible Party: Abbott Diagnostics Division
ClinicalTrials.gov Identifier: NCT00686205     History of Changes
Other Study ID Numbers: 7B5-02-05R05
Study First Received: May 21, 2008
Results First Received: January 13, 2010
Last Updated: December 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Diagnostics Division:
healthy donors
HIV positives

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

ClinicalTrials.gov processed this record on September 18, 2014