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

February 8, 2017 updated by: Bio-Rad Laboratories
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Observational

Enrollment (Actual)

419

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Fransisco, California, United States, 94110
        • HIV/AIDS Division, San Fransisco General Hospital
      • San Fransisco, California, United States, 94118
        • Blood Systems Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30333
        • Center for Disease Control and Prevention
    • Maryland
      • Silver Spring, Maryland, United States, 20910
        • Clinical Trials Center, Walter Reed Army Institute of Research
    • Washington
      • Seattle, Washington, United States, 98104-2499
        • University Of Washington AIDS Clinical Trials Unit, Harborview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HIV1 Positives: Individuals with confirmed HIV1 positive records AIDS Positives: Individuals with proved CDC stage 3 (AIDS) Low Risk patients: Low Risk individuals including potential military recruits, soldiers and civilians who have not reported any high risk behavior for HIV infection.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Known HIV1 positives
Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay
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).
Known AIDS
Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay
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).
Low risk (negatives)
Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Result of Assay (Bio-Rad Geenius HIV 1/2 Supplemental Assay) From Accuracy Analysis
Time Frame: Up to 9 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bio-Rad Laboratories

Investigators

  • Study Director: Scott Dennis, BS, Bio-Rad Laboratories

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 16, 2015

First Submitted That Met QC Criteria

March 27, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

February 8, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • RP.BVD.GEHIV.02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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