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The study is conducted to meet an FDA post market commitment to collect and report data on the performance of the ESA Chagas assay. A minimum of 50 donor specimens that are FDA-licensed ABBOTT PRISM Chagas repeatedly reactive (RR)will be tested with the ABBOTT ESA Chagas assay. In addition, minimum of 300 ABBOTT PRISM Chagas nonreactive (NR) unidentified donor specimens will be tested with ABBOTT ESA Chagas assay.
ABBOTT ESA Chagas testing will be performed at a minimum of two blood donor centers. Testing will be performed using the FDA-licensed ESA Chagas assay and will be performed in accordance with the ESA Chagas package insert. ABBOTT PRISM Chagas repeatedly reactive blood donor specimens identified by U.S. blood donor centers, as part of the routine blood donation process, will be tested with the FDA-licensed ESA Chagas. Specimens will also be tested with radioimmune precipitation assay (RIPA) for antibody to T. cruzi, a laboratory developed test, and the FDA-licensed ORTHO T. cruzi ELISA. The donor centers will contact the donors and request the donor to return to complete a questionnaire and provide a follow-up specimen.
In addition, a minimum of 300 blood donor specimens with ABBOTT PRISM Chagas nonreactive results will also be tested with ESA Chagas. These specimens will be unidentified, leftover specimens from routine donor testing and not individually identifiable. Specimens that are positive or indeterminate with ESA Chagas will be further tested with RIPA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testing Donor Specimens with ESA Chagas | Other | Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testing Donor Specimens with ESA Chagas | Device | Donors will be asked to return for a follow-up blood draw. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas | Up to six months |
| Measure | Description | Time Frame |
|---|---|---|
| ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas | Up to six months |
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PRISM Chagas Repeatedly Reactive Donor Specimens
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Stramer, Ph.D. | American National Red Cross | Principal Investigator |
| Sharon Gordon, MS, MBA, MT | LifeSource | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LifeSource | Rosemont | Illinois | 60018 | United States | ||
| American Red Cross |
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| ID | Title | Description |
|---|---|---|
| FG000 | Testing Donor Specimens With ESA Chagas | Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw. Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Donor specimens PRISM Chagas Repeatly Reactive
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| ID | Title | Description |
|---|---|---|
| BG000 | Testing Donor Specimens With ESA Chagas | Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw. Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Routine whole blood donors |
| 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas | Posted | Number | 95% Confidence Interval | percent agreement to RIPA | Up to six months |
|
|
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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 | Testing Donor Specimens With ESA Chagas | Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw. Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Kaesdorf, Associate Director Clinical Affairs | Abbott | 847-937-8702 | barbara.kaesdorf@abbott.com |
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| ID | Term |
|---|---|
| D014355 | Chagas Disease |
| ID | Term |
|---|---|
| D014352 | Trypanosomiasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
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| ID | Term |
|---|---|
| D001681 | Biological Assay |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Gaithersburg |
| Maryland |
| 20877 |
| United States |
| Number |
| participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas | Posted | Number | 95% Confidence Interval | percentage of specimens ESA negative | Up to six months |
|
|
|
| 0 |
| 63 |
| 0 |
| 63 |
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| D007239 |
| Infections |
| D000079426 | Vector Borne Diseases |