HIV
Conditions
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)
Interventions
DEVICEGeenius 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).
Sponsors
Bio-Rad Laboratories
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Result of Assay (Bio-Rad Geenius HIV 1/2 Supplemental Assay) From Accuracy Analysis | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Known HIV1 Positives Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay
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). | 87 |
| Known AIDS Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay
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). | 212 |
| Low Risk (Negatives) Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay
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). | 120 |
| Total | 419 |
Baseline characteristics
| Characteristic | Known HIV1 Positives | Known AIDS | Low Risk (Negatives) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 11 Participants | 0 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 85 Participants | 201 Participants | 120 Participants | 406 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 18 Participants | 25 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants | 70 Participants | 43 Participants | 144 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 8 Participants | 3 Participants | 17 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) White | 45 Participants | 119 Participants | 56 Participants | 220 Participants |
| Region of Enrollment United States | 87 participants | 212 participants | 120 participants | 419 participants |
| Sex: Female, Male Female | 9 Participants | 32 Participants | 55 Participants | 96 Participants |
| Sex: Female, Male Male | 78 Participants | 180 Participants | 65 Participants | 323 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 87 | 0 / 212 | 0 / 120 |
| serious Total, serious adverse events | 0 / 87 | 0 / 212 | 0 / 120 |
Outcome results
Primary
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.
Time frame: Up to 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Known HIV1 Positives | Diagnostic Result of Assay (Bio-Rad Geenius HIV 1/2 Supplemental Assay) From Accuracy Analysis | 100 Percentage of True Results |
| Known AIDS | Diagnostic Result of Assay (Bio-Rad Geenius HIV 1/2 Supplemental Assay) From Accuracy Analysis | 99.06 Percentage of True Results |
| Low Risk (Negatives) | Diagnostic Result of Assay (Bio-Rad Geenius HIV 1/2 Supplemental Assay) From Accuracy Analysis | 95.83 Percentage of True Results |