Healthy Donors, HIV Positive
Conditions
Keywords
healthy donors, HIV positives
Brief summary
To test blood samples from volunteer donors of whole blood and blood components using a new investigational test that detects human immunodeficiency virus (HIV) infection. Results will be compared to the current HIV screening assay.
Interventions
DEVICEcollection of follow-up sample based on PRISM HIV O Plus result
Test blood samples with investigational HIV assay. If results are reactive, donors may be deferred and asked to return for a follow-up blood draw.
Sponsors
Abbott Diagnostics Division
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy donors that have consented to study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PRISM HIV O Plus Test Data for Specificity | 12 months | Negative HIV status was determined by the results of the HIV-1/HIV-2 comparator assay and HIV-1 qualitatitve RNA. |
| PRISM HIV O Plus Test Data for Sensitivity | 12 months | Final HIV status was determined according to a supplemental testing algorithm for specimens positive by the investigational assay. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot and HIV-1 ribonucleic acid (RNA). |
Countries
United States
Participant flow
Recruitment details
21606 donors enrolled from 6 geographically distinct blood donor and 1 plasmapheresis center. All donors were eligible if they signed a study consent form. In addition, 1388 specimens positive for HIV antibodies and 1117 specimens from US individuals at increased risk of HIV infection or from an HIV-2 endemic area.
Pre-assignment details
All subjects were assigned to one group. There was no pre-screening criteria specific for this study.
Participants by arm
| Arm | Count |
|---|---|
| ABBOTT PRISM® HIV O Plus Assay Results for Specificity Blood specimens collected from donors were tested by the investigational HIV test. | 21,606 |
| ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay. | 2,505 |
| Total | 24,111 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 127 | 0 |
| Overall Study | Specimen handling procedure altered | 5,878 | 0 |
| Overall Study | Specimens not confirmed HIV positive | 0 | 981 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | ABBOTT PRISM® HIV O Plus Assay Results for Specificity | ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity | Total |
|---|---|---|---|
| Age, Customized >= 17 years | 21606 Participants | 2454 Participants | 24060 Participants |
| Age, Customized not collected | 0 Participants | 51 Participants | 51 Participants |
| Region of Enrollment Cameroon | 0 participants | 51 participants | 51 participants |
| Region of Enrollment Côte D'Ivoire | 0 participants | 840 participants | 840 participants |
| Region of Enrollment United States | 21606 participants | 1614 participants | 23220 participants |
| Sex/Gender, Customized Female | 0 Participants | 441 Participants | 441 Participants |
| Sex/Gender, Customized Male | 0 Participants | 1683 Participants | 1683 Participants |
| Sex/Gender, Customized Not Collected | 21606 Participants | 381 Participants | 21987 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 0 |
| serious Total, serious adverse events | 0 / 19 | 0 / 0 |
Outcome results
Primary
PRISM HIV O Plus Test Data for Sensitivity
Final HIV status was determined according to a supplemental testing algorithm for specimens positive by the investigational assay. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot and HIV-1 ribonucleic acid (RNA).
Time frame: 12 months
Population: 1,388 specimens from individuals positive for HIV antibodies and 136 specimens positive by supplemental testing from US individuals at increased risk of HIV infection or from an HIV-2 endemic area. These 1,524 specimens were used for the sensitivity calculation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HIV Negative Donors | PRISM HIV O Plus Test Data for Sensitivity | PRISM HIV O Plus reactive | 1524 participants |
| HIV Negative Donors | PRISM HIV O Plus Test Data for Sensitivity | PRISM HIV O Plus nonreactive | 0 participants |
95% CI: [99.76, 100]Binomial Exact
Primary
PRISM HIV O Plus Test Data for Specificity
Negative HIV status was determined by the results of the HIV-1/HIV-2 comparator assay and HIV-1 qualitatitve RNA.
Time frame: 12 months
Population: The analysis was per the protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HIV Negative Donors | PRISM HIV O Plus Test Data for Specificity | PRISM HIV O Plus reactive | 10 participants |
| HIV Negative Donors | PRISM HIV O Plus Test Data for Specificity | PRISM HIV O Plus nonreactive | 15589 participants |
95% CI: [99.88, 99.97]Binomial Exact