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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBOTT PRISM HIV O Plus assay for Specificity | Experimental | All subjects will have their blood tested by the investigational HIV test. |
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| ABBOTT PRISM HIV O Plus Assay for Sensitivity | No Intervention | Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| collection of follow-up sample based on PRISM HIV O Plus result | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| 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). | 12 months |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mississippi Valley Regional Blood Center | Davenport | Iowa | 52807 | United States | ||
| Community Blood Center of Greater Kansas City |
All subjects were assigned to one group. There was no pre-screening criteria specific for this study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | ABBOTT PRISM® HIV O Plus Assay Results for Specificity | Blood specimens collected from donors were tested by the investigational HIV test. |
| FG001 | ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Kansas City |
| Missouri |
| 64111 |
| United States |
| Community Blood Center | Dayton | Ohio | 45402 | United States |
| American Red Cross | Philadelphia | Pennsylvania | 19123 | United States |
| Interstate Blood Bank, Inc. | Memphis | Tennessee | 38134 | United States |
| South Texas Blood And Tissue Center | San Antonio | Texas | 78201 | United States |
| Puget Sound Blood Center | Renton | Washington | 98057 | United States |
Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ABBOTT PRISM® HIV O Plus Assay Results for Specificity | Blood specimens collected from donors were tested by the investigational HIV test. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
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| Sex/Gender, Customized | Number | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | The analysis was per the protocol. | Posted | Number | participants | 12 months |
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| 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). | 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. | Posted | Number | participants | 12 months |
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Subject related adverse events related to blood collection of the 19 follow-up specimens - 8/23/07 to 8/12/08.
Adverse event reporting was only applicable to the 19 donors that returned for follow-up specimen collection. Adverse event reporting does not apply to the donor specimens collected as part of the routine donation or for the specimens used for sensitivity provided by Abbott.
There were no device adverse events associated with testing.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABBOTT PRISM® HIV O Plus Assay Results for Specificity | Blood specimens collected from donors were tested by the investigational HIV test. | 0 | 19 | 0 | 19 | ||
| EG001 | 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. | 0 | 0 | 0 | 0 |
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The PI must provide a copy of any proposed publication or presentation at least 30 days prior to submission for sponsor's review/approval. The PI must incorporate changes as the sponsor requires in order to protect the sponsor's proprietary rights and interests. The sponsor may require the PI to include acknowledgement of the sponsor's role in the study. The PI may be requested to delay publication/presentation an extra 60 days to enable sponsor to secure patent or other proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peggy Moreno | Abbott Diagnostics Division | 847-937-2044 | Peggy.Moreno@abbott.com |
| ID | Term |
|---|---|
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| Title | Measurements |
|---|---|
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| Female |
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| Not Collected |
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| Côte D'Ivoire |
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| Cameroon |
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