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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401555
• Other study ID #: RP.BVD.GEHIV.02
• Status: Completed
• Phase: N/A
• First received: March 16, 2015
• Last updated: March 27, 2015
• Start date: April 2013
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: Bio-Rad Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 419
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Criteriafor 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV

Intervention

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).

Locations

Country	Name	City	State
United States	Center for Disease Control and Prevention	Atlanta	Georgia
United States	Blood Systems Research Institute	San Fransisco	California
United States	HIV/AIDS Division, San Fransisco General Hospital	San Fransisco	California
United States	University Of Washington AIDS Clinical Trials Unit, Harborview Medical Center	Seattle	Washington
United States	Clinical Trials Center, Walter Reed Army Institute of Research	Silver Spring	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Bio-Rad Laboratories

Country where clinical trial is conducted

United States, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic result of assay (Bio-Rad Geenius HIV 1/2 Supplemental Assay)		Up to 9 months	No