Evaluation of Diagnostic HIV Ag/Ab Combo Assay
Human Immunodeficiency Viruses
About this trial
This is an interventional diagnostic trial for Human Immunodeficiency Viruses
Eligibility Criteria
Normal Healthy Population:
Inclusion Criteria:
- Apparently healthy individual at the time of enrollment as affirmed by the subject
Exclusion Criteria:
- 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
Sites / Locations
- Radiant Research
- Pinellas County Health Dept, Florida Department of Health
- Springfield Clinic, LLP
- Minneapolis Medical Research Foundation
- Jacobi Medical Center
- John T. Mather Memorial Hospital
- M.S. Hershey Medical Center
- University of Texas Medical Branch at Galveston
- University of Texas Medical Branch
- Planned Parenthood of Houston and Southeast Texas, Inc.
- ARUP Laboratories
- Midwest Research Specialists, LLC
- Clement J. Zablocki VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
No Intervention
Experimental
ARCHITECT HIV Ag/Ab Combo Specificity
ARCHITECT HIV Ag/Ab Combo Sensitivity
ARCHITECT HIV Ag/Ab Combo Reactivity
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.
Specimen with confirmed positive HIV Antigen, HIV-1 antibody, or HIV-2 antibody will be tested by the investigational HIV test.
Specimen collected from individuals at risk for HIV infection will be tested by the investigational HIV test.