NCT02401555

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 419 (actual)
• Sponsor: Bio-Rad Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed 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)

Conditions

• HIV

Interventions

Type	Name	Description
DEVICE	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).

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2015-03-30
• Last updated: 2017-03-28
• Results posted: 2017-03-28

Locations

5 sites across 1 country: United States