N/A
N=419
Performance Evaluation of the Bio-Rad Geenius HIV1/2 Supplemental Assay
HIV
Bottom Line
View on ClinicalTrials.gov: NCT02401555 ↗Enrolled (actual)
419
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Diagnostic Result of Assay (Bio-Rad Geenius HIV 1/2 Supplemental Assay) From Accuracy Analysis — 100; 99.06; 95.83 Percentage of True Results
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Geenius HIV1/2 Supplemental Assay (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bio-Rad Laboratories
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Result of Assay (Bio-Rad Geenius HIV 1/2 Supplemental Assay) From Accuracy Analysis |
100; 99.06; 95.83 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02401555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.