Clinical trial NCT02401555: Performance Evaluation of the Bio-Rad Geenius HIV1/2 Supplemental Assay
Official title: Performance Evaluation of the Bio-Rad Geenius HIV1/2 Supplemental Assay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Lead sponsor: Bio-Rad Laboratories
Sponsor class: INDUSTRY
First posted: 2015-03-30
Enrollment: 419
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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).

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)

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

Primary outcomes:
measure: Diagnostic Result of Assay (Bio-Rad Geenius HIV 1/2 Supplemental Assay) From Accuracy Analysis
timeFrame: Up to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Fransisco
country: United States
facility: HIV/AIDS Division, San Fransisco General Hospital
state: California
city: San Fransisco
country: United States
facility: Blood Systems Research Institute
state: California
city: Atlanta
country: United States
facility: Center for Disease Control and Prevention
state: Georgia
city: Silver Spring
country: United States
facility: Clinical Trials Center, Walter Reed Army Institute of Research
state: Maryland
city: Seattle
country: United States
facility: University Of Washington AIDS Clinical Trials Unit, Harborview Medical Center
state: Washington
Study officials:
affiliation: Bio-Rad Laboratories
name: Scott Dennis, BS
role: STUDY_DIRECTOR
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