Performance Evaluation of the Bio-Rad Geenius HIV1/2 Supplemental Assay
NCT ID: NCT02401555
Last Updated: 2017-03-28
Study Results
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View full resultsBasic Information
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COMPLETED
419 participants
OBSERVATIONAL
2013-04-30
2013-12-31
Brief Summary
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Detailed Description
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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:
1. HIV-1/HIV-2 False Reactive Samples (N=100)
2. Unrelated Medical Conditions (N=40).
3. Normal Pediatric Patients (N=10)
4. HIV-1 Positive Pediatric Patients (N=40)
5. HIV-1 Non B Group M Subtypes (N=136)
6. HIV-1 Group O Antibody Positive (N=15)
7. Known HIV-2 Positive Population (N=200)
8. HIV Performance Panels
1. Anti-HIV-1/2 Combo Performance Panel: PRZ208 (N=15)
2. HIV-1 Low Titer Panel: PRB109 (N=20)
3. HIV-1 Incidence / Prevalence Panel: PRB601 (N=15)
4. HIV-1 Seroconversion Panels (26 Panels, N=230)
9. CEPHIA Evaluation Panel (N=2500)
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Known HIV1 positives
Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay
Geenius HIV1/2 Supplemental Assay
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).
Known AIDS
Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay
Geenius HIV1/2 Supplemental Assay
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).
Low risk (negatives)
Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay
Geenius HIV1/2 Supplemental Assay
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).
Interventions
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Geenius HIV1/2 Supplemental Assay
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).
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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.
* 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
18 Years
ALL
Yes
Sponsors
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Bio-Rad Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Scott Dennis, BS
Role: STUDY_DIRECTOR
Bio-Rad Laboratories
Locations
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HIV/AIDS Division, San Fransisco General Hospital
San Francisco, California, United States
Blood Systems Research Institute
San Francisco, California, United States
Center for Disease Control and Prevention
Atlanta, Georgia, United States
Clinical Trials Center, Walter Reed Army Institute of Research
Silver Spring, Maryland, United States
University Of Washington AIDS Clinical Trials Unit, Harborview Medical Center
Seattle, Washington, United States
Countries
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References
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Other Identifiers
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RP.BVD.GEHIV.02
Identifier Type: -
Identifier Source: org_study_id
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