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

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ClinicalTrials.gov Identifier: NCT02401555
Recruitment Status : Completed
First Posted : March 30, 2015
Results First Posted : March 28, 2017
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Bio-Rad Laboratories

Brief 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).

Condition or disease Intervention/treatment
HIV Device: Geenius HIV1/2 Supplemental Assay

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)

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Study Type : Observational
Actual Enrollment : 419 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Performance Evaluation of the Bio-Rad Geenius HIV1/2 Supplemental Assay
Study Start Date : April 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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).




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
Serum and plasma samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401555


Locations
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United States, California
HIV/AIDS Division, San Fransisco General Hospital
San Fransisco, California, United States, 94110
Blood Systems Research Institute
San Fransisco, California, United States, 94118
United States, Georgia
Center for Disease Control and Prevention
Atlanta, Georgia, United States, 30333
United States, Maryland
Clinical Trials Center, Walter Reed Army Institute of Research
Silver Spring, Maryland, United States, 20910
United States, Washington
University Of Washington AIDS Clinical Trials Unit, Harborview Medical Center
Seattle, Washington, United States, 98104-2499
Sponsors and Collaborators
Bio-Rad Laboratories
Investigators
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Study Director: Scott Dennis, BS Bio-Rad Laboratories
Publications:

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Responsible Party: Bio-Rad Laboratories
ClinicalTrials.gov Identifier: NCT02401555    
Other Study ID Numbers: RP.BVD.GEHIV.02
First Posted: March 30, 2015    Key Record Dates
Results First Posted: March 28, 2017
Last Update Posted: March 28, 2017
Last Verified: February 2017