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

NCT02401555 | Completed Results

• 1 other identifier: RP.BVD.GEHIV.02
• Study Type: observational
• Target: 419
• Locations: 1 country
• Sites: 5

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).

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Diagnostic Result of Assay (Bio-Rad Geenius HIV 1/2 Supplemental Assay) From Accuracy Analysis

  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

Study Arms (3)

Known HIV1 positives

Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay

Device: Geenius HIV1/2 Supplemental Assay

Known AIDS

Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay

Device: Geenius HIV1/2 Supplemental Assay

Low risk (negatives)

Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay

Device: Geenius HIV1/2 Supplemental Assay

Interventions

Geenius HIV1/2 Supplemental Assay DEVICE

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; Known HIV1 positives; Low risk (negatives)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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

Sponsors & Collaborators

• Bio-Rad Laboratories: lead

Study Sites (5)

HIV/AIDS Division, San Fransisco General Hospital

San Francisco, California, 94110, United States

Location

Blood Systems Research Institute

San Francisco, California, 94118, United States

Location

Center for Disease Control and Prevention

Atlanta, Georgia, 30333, United States

Location

Clinical Trials Center, Walter Reed Army Institute of Research

Silver Spring, Maryland, 20910, United States

Location

University Of Washington AIDS Clinical Trials Unit, Harborview Medical Center

Seattle, Washington, 98104-2499, United States

Location

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma samples

Results Point of Contact

• Title: David Bhend
• Organization: Bio-Rad Laboratories

david_bhend@bio-rad.com

425 498 1758

Study Officials

• Scott Dennis, BS

  Bio-Rad Laboratories

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 30, 2015
• Study Start: April 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 28, 2017
• Results First Posted: March 28, 2017

Record last verified: 2017-02

Locations

US (5)