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

Primary Purpose

Healthy Donors, HIV Positive

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
collection of follow-up sample based on PRISM HIV O Plus result
Sponsored by
Abbott Diagnostics Division
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Healthy Donors focused on measuring healthy donors, HIV positives

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy donors that have consented to study

Sites / Locations

  • Mississippi Valley Regional Blood Center
  • Community Blood Center of Greater Kansas City
  • Community Blood Center
  • American Red Cross
  • Interstate Blood Bank, Inc.
  • South Texas Blood And Tissue Center
  • Puget Sound Blood Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ABBOTT PRISM HIV O Plus assay for Specificity

ABBOTT PRISM HIV O Plus Assay for Sensitivity

Arm Description

All subjects will have their blood tested by the investigational HIV test.

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

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Full Information

First Posted
May 21, 2008
Last Updated
December 16, 2011
Sponsor
Abbott Diagnostics Division
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1. Study Identification

Unique Protocol Identification Number
NCT00686205
Brief Title
Evaluation of a Human Immunodeficiency Virus (HIV) Blood Screening Assay
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Diagnostics Division

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Donors, HIV Positive
Keywords
healthy donors, HIV positives

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABBOTT PRISM HIV O Plus assay for Specificity
Arm Type
Experimental
Arm Description
All subjects will have their blood tested by the investigational HIV test.
Arm Title
ABBOTT PRISM HIV O Plus Assay for Sensitivity
Arm Type
No Intervention
Arm Description
Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
Intervention Type
Device
Intervention Name(s)
collection of follow-up sample based on PRISM HIV O Plus result
Intervention Description
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.
Primary Outcome Measure Information:
Title
PRISM HIV O Plus Test Data for Specificity
Description
Negative HIV status was determined by the results of the HIV-1/HIV-2 comparator assay and HIV-1 qualitatitve RNA.
Time Frame
12 months
Title
PRISM HIV O Plus Test Data for Sensitivity
Description
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).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy donors that have consented to study
Facility Information:
Facility Name
Mississippi Valley Regional Blood Center
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52807
Country
United States
Facility Name
Community Blood Center of Greater Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Community Blood Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45402
Country
United States
Facility Name
American Red Cross
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19123
Country
United States
Facility Name
Interstate Blood Bank, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38134
Country
United States
Facility Name
South Texas Blood And Tissue Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78201
Country
United States
Facility Name
Puget Sound Blood Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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