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

NCT00686205 | Completed Phase 3 Results

• 1 other identifier: 7B5-02-05R05
• Study Type: interventional
• Target: 24,111
• Locations: 1 country
• Sites: 7

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.

Conditions

Healthy Donors; HIV Positive

Keywords

healthy donors; HIV positives

Outcome Measures

Primary Outcomes (2)

• PRISM HIV O Plus Test Data for Specificity

  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

  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

Study Arms (2)

ABBOTT PRISM HIV O Plus assay for Specificity

EXPERIMENTAL

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

ABBOTT PRISM HIV O Plus Assay for Sensitivity

NO INTERVENTION

Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.

Interventions

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

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy donors that have consented to study

Sponsors & Collaborators

• Abbott Diagnostics Division: lead

Study Sites (7)

Mississippi Valley Regional Blood Center

Davenport, Iowa, 52807, United States

Location

Community Blood Center of Greater Kansas City

Kansas City, Missouri, 64111, United States

Location

Community Blood Center

Dayton, Ohio, 45402, United States

Location

American Red Cross

Philadelphia, Pennsylvania, 19123, United States

Location

Interstate Blood Bank, Inc.

Memphis, Tennessee, 38134, United States

Location

South Texas Blood And Tissue Center

San Antonio, Texas, 78201, United States

Location

Puget Sound Blood Center

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Peggy Moreno
• Organization: Abbott Diagnostics Division

Peggy.Moreno@abbott.com

847-937-2044

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 29, 2008
• Study Start: August 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 28, 2011
• Results First Posted: July 5, 2010

Record last verified: 2011-12

Locations

US (7)