Evaluation of Diagnostic HIV Ag/Ab Combo Assay

Study Overview
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Brief Summary
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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
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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).

Official Title
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Evaluation of ARCHITECT HIV Ag/Ab Combo Assay

Conditions
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Human Immunodeficiency Viruses

Intervention / Treatment
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* Device: ARCHITECT HIV Ag/Ab Combo
* Device: ARCHITECT HIV Ag/Ab Combo


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARCHITECT HIV Ag/Ab Combo Specificity<br>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. | Device: ARCHITECT HIV Ag/Ab Combo<br>* Test blood samples with investigational HIV assay. If results for specimens from the normal healthy population or pregnant female population at risk for HIV infection are reactive, samples will be tested with supplemental HIV assays. If all supplemental HIV assays are negative, subject will be asked to return for a follow-up blood draw.<br>|
| No Intervention: ARCHITECT HIV Ag/Ab Combo Sensitivity<br>Specimen with confirmed positive HIV Antigen, HIV-1 antibody, or HIV-2 antibody will be tested by the investigational HIV test. | |
| Experimental: ARCHITECT HIV Ag/Ab Combo Reactivity<br>Specimen collected from individuals at risk for HIV infection will be tested by the investigational HIV test. | Device: ARCHITECT HIV Ag/Ab Combo<br>* Test blood samples with investigational HIV assay. If results for specimens from the at risk population are reactive, samples will be tested with supplemental HIV assays. If all supplemental HIV assays are negative, subject will be asked to return for a follow-up blood draw when possible.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection | 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. | 3 months | 
| Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens | 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. | 3 months | 
| Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population | 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. | 3 months | 
| Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age) | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations | 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. | 3 months |