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.|
|ClinicalTrials.gov Identifier: NCT00686205|
Recruitment Status : Completed
First Posted : May 29, 2008
Results First Posted : July 5, 2010
Last Update Posted : December 28, 2011
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
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.
- 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.
- 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).
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 ClinicalTrials.gov 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|