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

Phase 3

Completed

• Conditions: Healthy Donors; HIV Positive
• Interventions: Device: collection of follow-up sample based on PRISM HIV O Plus result

• Registration Number: NCT00686205
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-28
• Study First Posted: 2008-05-29
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2010-01-13
• Results First Submitted QC: 2010-06-04
• Results First Posted: 2010-07-05
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-16
• Last Update Posted: 2011-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24111

Inclusion Criteria

• Healthy donors that have consented to study

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABBOTT PRISM HIV O Plus assay for Specificity	collection of follow-up sample based on PRISM HIV O Plus result	All subjects will have their blood tested by the investigational HIV test.

Primary Outcome Measures

Name	Time	Method
PRISM HIV O Plus Test Data for Specificity	12 months	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	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).

Trial Locations

Locations (7)

Mississippi Valley Regional Blood Center; 🇺🇸 Davenport, Iowa, United States

Community Blood Center of Greater Kansas City; 🇺🇸 Kansas City, Missouri, United States

American Red Cross; 🇺🇸 Philadelphia, Pennsylvania, United States

Puget Sound Blood Center; 🇺🇸 Renton, Washington, United States

Community Blood Center; 🇺🇸 Dayton, Ohio, United States

South Texas Blood And Tissue Center; 🇺🇸 San Antonio, Texas, United States

Interstate Blood Bank, Inc.; 🇺🇸 Memphis, Tennessee, United States