HIV Clinical Trial - Performance Evaluation of the Bio-Rad Geenius HIV1/2

Status Completed

Clinical Trial Summary

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).

Clinical Trial Description

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:

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) ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02401555
Study type	Observational
Source	Bio-Rad Laboratories
Contact
Status	Completed
Phase	N/A
Start date	April 2013
Completion date	December 2013

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms