Evaluation of Diagnostic HIV Ag/Ab Combo Assay
- Conditions
- Human Immunodeficiency Viruses
- Interventions
- Device: ARCHITECT HIV Ag/Ab Combo
- Registration Number
- NCT00933933
- Lead Sponsor
- Abbott Diagnostics Division
- Brief Summary
To test blood specimens using a new investigational test that detects antigen and antibody to human immunodeficiency virus (HIV). Results will be compared to an approved HIV antibody test and supplemental testing performed to determine HIV status.
- Detailed Description
All specimens collected under separate specimen collection protocols or obtained from specimen suppliers will be provided to the clinical sites performing the investigational HIV test.
This includes 6252 specimens collected from normal healthy individuals (7B5-02-05Z01-01: Collection of Specimens Used in Abbott Laboratories In Vitro Diagnostic HIV and Hepatitis Assays Clinical Studies)and from specimen suppliers. 588 specimens from HIV-infected pediatric subjects and 448 pregnant females at risk for HIV infection collected under protocol (7B5-02-05Z01-02: Collection of Pediatric and Pregnant Female Specimens Used in the Abbott Laboratories In Vitro Diagnostic HIV Assay)and from specimen suppliers. All specimens were previously collected and frozen, except for a subset of 586 specimens from normal healthy population and 55 specimen from pregnant females at risk for HIV infection which were collected under separate specimen collection protocols and tested as fresh specimens during the study.
In addition, 83 specimens that were HIV antigen positive, 1121 specimens that were HIV-1 antibody positive, 201 specimens that were HIV-2 antibody positive, and 1409 specimens from US at risk for HIV infection or from HIV-2 endemic area were all obtained from specimen suppliers, except for 11 pediatric specimens collected under a separate protocol (7B5-02-05Z01-02: Collection of Pediatric and Pregnant Female Specimens Used in the Abbott Laboratories In Vitro Diagnostic HIV Assay).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 635
- Apparently healthy individual at the time of enrollment as affirmed by the subject
- HIV infection as affirmed by the subject
Pregnant Female Population at Risk for HIV Infection:
Inclusion Criteria:
- Subject is a pregnant female
- Subject has risk factor for HIV infection
Exclusion Criteria:
- HIV infection as affirmed by the subject
HIV-1 Positive Pregnant Female Subjects
Inclusion Criteria:
- Subject is a pregnant female in first, second, or third trimester
- Subject must have documented HIV infection
Exclusion Criteria:
- None
HIV-1 Positive Pediatric Subjects
Inclusion Criteria:
- Subject must be 2 years to 16 years of age
- Subject must have documented HIV infection (e.g., Western blot positive or HIV RNA positive/detectable)
Exclusion Criteria:
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ARCHITECT HIV Ag/Ab Combo Specificity ARCHITECT HIV Ag/Ab Combo Specimens collected from normal apparently healthy individuals at low risk for HIV infection will be tested by the investigational HIV test and FDA-licensed HIV test. ARCHITECT HIV Ag/Ab Combo Reactivity ARCHITECT HIV Ag/Ab Combo Specimen collected from individuals at risk for HIV infection will be tested by the investigational HIV test.
- Primary Outcome Measures
Name Time Method Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection 3 months HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.
Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population 3 months HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.
Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age) 3 months HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.
Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens 3 months Positive HIV status was determined by the results of the HIV-1 Western blot, HIV-2 Western blot, and/or HIV-1 ribonucleic acid (RNA) test.
- Secondary Outcome Measures
Name Time Method Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations 3 months Reactivity was determined by the results of the Architect HIV Ag/Ab Combo assay and supplemental testing by HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.
Trial Locations
- Locations (13)
Planned Parenthood of Houston and Southeast Texas, Inc.
🇺🇸Houston, Texas, United States
Minneapolis Medical Research Foundation
🇺🇸Minneapolis, Minnesota, United States
Jacobi Medical Center
🇺🇸Bronx, New York, United States
Pinellas County Health Dept, Florida Department of Health
🇺🇸St. Petersburg, Florida, United States
M.S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
ARUP Laboratories
🇺🇸Salt Lake City, Utah, United States
Midwest Research Specialists, LLC
🇺🇸Milwaukee, Wisconsin, United States
Clement J. Zablocki VA Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Springfield Clinic, LLP
🇺🇸Springfield, Illinois, United States
John T. Mather Memorial Hospital
🇺🇸Port Jefferson, New York, United States
University of Texas Medical Branch at Galveston
🇺🇸Galveston, Texas, United States
Radiant Research
🇺🇸Phoenix, Arizona, United States