Evaluation of ARCHITECT HIV Ag/Ab Combo Assay
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 635
- 试验地点
- 26
- 主要终点
- Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy individual at the time of enrollment as affirmed by the subject
排除标准
- •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:
- •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:
研究组 & 干预措施
ARCHITECT HIV Ag/Ab Combo Sensitivity
Specimen with confirmed positive HIV Antigen, HIV-1 antibody, or HIV-2 antibody will be tested by the investigational HIV test.
ARCHITECT HIV Ag/Ab Combo Reactivity
Specimen collected from individuals at risk for HIV infection will be tested by the investigational HIV test.
干预措施: ARCHITECT HIV Ag/Ab Combo (Device)
ARCHITECT HIV Ag/Ab Combo Specificity
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.
干预措施: ARCHITECT HIV Ag/Ab Combo (Device)
结局指标
主要结局
Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
- Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations(3 months)