Trial Outcomes & Findings for Performance Evaluation of the Bio-Rad Geenius HIV1/2 Supplemental Assay (NCT NCT02401555)
NCT ID: NCT02401555
Last Updated: 2017-03-28
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
419 participants
Primary outcome timeframe
Up to 9 months
Results posted on
2017-03-28
Participant Flow
Participant milestones
| Measure |
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).
|
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).
|
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).
|
|---|---|---|---|
|
Overall Study
STARTED
|
87
|
212
|
120
|
|
Overall Study
COMPLETED
|
87
|
212
|
120
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Performance Evaluation of the Bio-Rad Geenius HIV1/2 Supplemental Assay
Baseline characteristics by cohort
| Measure |
Known HIV1 Positives
n=87 Participants
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).
|
Known AIDS
n=212 Participants
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).
|
Low Risk (Negatives)
n=120 Participants
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).
|
Total
n=419 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
85 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
406 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
323 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
144 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
220 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
87 participants
n=5 Participants
|
212 participants
n=7 Participants
|
120 participants
n=5 Participants
|
419 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 9 monthsThe 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.
Outcome measures
| Measure |
Known HIV1 Positives
n=87 Participants
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).
|
Known AIDS
n=212 Participants
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).
|
Low Risk (Negatives)
n=120 Participants
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).
|
|---|---|---|---|
|
Diagnostic Result of Assay (Bio-Rad Geenius HIV 1/2 Supplemental Assay) From Accuracy Analysis
|
100 Percentage of True Results
Interval 95.76 to 100.0
|
99.06 Percentage of True Results
Interval 96.62 to 99.74
|
95.83 Percentage of True Results
Interval 90.61 to 98.21
|
Adverse Events
Known HIV1 Positives
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Known AIDS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Risk (Negatives)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a five year period from the time of the non-disclosure agreement execution.
- Publication restrictions are in place
Restriction type: OTHER