Performance Evaluation of the Bio-Rad Geenius HIV1/2 Supplemental Assay

Study Overview
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Brief Summary
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The purpose of this study was to evaluate the performance of the Bio-Rad Geenius HIV 1/2 Supplemental Assay, a single-use immunochromatographic assay for the confirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2) in fingerstick whole blood, venous whole blood, serum, or plasma samples (EDTA, heparin, and sodium citrate).

Detailed Description
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Prospectively collected matched sample types, including fingerstick (capillary blood), serum, plasma, and whole venous blood were obtained from subjects at three clinical trial sites within the United States. Informed consent was used to enroll subjects at low risk for HIV (N=120 subjects) and from subjects pre-diagnosed as HIV positive (N=299 subjects). The fingerstick samples were tested with Geenius HIV 1/2 Supplemental Assay at the collection site, while the remaining matched sample types, (serum, plasma, and whole venous blood) were sent to a clinical lab to be tested on the Geenius HIV 1/2 Supplemental Assay. Results of the Geenius HIV 1/2 Supplemental Assay on each of 4 matched sample were compared to the serum result on the Bio-Rad GS HIV 1/HIV 2 PLUS O EIA, Bio-Rad HIV-1 Western blot, and the Bio-Rad Multispot HIV 1/HIV-2 Rapid Test (reference methods). Retrospective specimens from repositories or specimens purchased from commercial vendors were also included in the study. In addition to the Geenius HIV 1/2 Supplemental Assay, the GS HIV 1/HIV 2 PLUS O EIA, Bio-Rad HIV-1 Western blot, and the Bio-Rad Multispot HIV 1/HIV-2 Rapid Test were utilized as reference methods. Historical data, when available, was also used. All samples were identified with a unique study number and included the following populations/panels: HIV-1/HIV-2 False Reactive Samples (N=100) Unrelated Medical Conditions (N=40). Normal Pediatric Patients (N=10) HIV-1 Positive Pediatric Patients (N=40) HIV-1 Non B Group M Subtypes (N=136) HIV-1 Group O Antibody Positive (N=15) Known HIV-2 Positive Population (N=200) HIV Performance Panels Anti-HIV-1/2 Combo Performance Panel: PRZ208 (N=15) HIV-1 Low Titer Panel: PRB109 (N=20) HIV-1 Incidence / Prevalence Panel: PRB601 (N=15) HIV-1 Seroconversion Panels (26 Panels, N=230) CEPHIA Evaluation Panel (N=2500)

Official Title
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Performance Evaluation of the Bio-Rad Geenius HIV1/2 Supplemental Assay

Conditions
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HIV

Intervention / Treatment
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* Device: Geenius HIV1/2 Supplemental Assay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for HIV1 positives and AIDS positive populations: Should be able to provide informed consent. Must be greater than or equal to 18 years of age. Agree to provide a finger stick sample. Agree to provide upto 20 mL of blood by veni-puncture. Must have sufficient medical history to provide data required for the case report form. Exclusion Criteria for HIV1 positives and AIDS positive populations: Unable to provide informed consent Subjects who have received an experimental vaccine for HIV. Individuals except AIDS patients who are currently on ARV therapy with the duration from the start of therapy for more than 6 months. Inclusion Criteria for Low Risk population: Able to provide Informed consent Must be greater than or equal to 18 years of age. Subject does not report any high risk behaviors for HIV infection. Of unknown HIV status. Exclusion criteria for Low Risk Population: Unable to provide informed consent. Individuals with one or more high risk behaviors with HIV infection within the previous 6 months. Self reported history of HIV infection Prior receipt of HIV infection

Ages Eligible for Study
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Minimum Age: 18 Years

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Known HIV1 positives<br>Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay | Device: Geenius HIV1/2 Supplemental Assay<br>* The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate).<br>|
| Known AIDS<br>Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay | Device: Geenius HIV1/2 Supplemental Assay<br>* The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate).<br>|
| Low risk (negatives)<br>Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay | Device: Geenius HIV1/2 Supplemental Assay<br>* The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Result of Assay (Bio-Rad Geenius HIV 1/2 Supplemental Assay) From Accuracy Analysis | The purpose of this study was to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay, a single-use immunochromatographic assay for the confirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types1 and 2 (HIV-1 and HIV-2) in fingerstick whole blood, venous whole blood, serum, or plasma (EDTA, heparin and sodium citrate). The Accuracy analysis on the serum samples is a proportion of results that are correctly identified as such. | Up to 9 months |