Abbott ESA Chagas Assay Post-Market Study
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Abbott ESA Chagas Assay Post-Market Study|
- ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas [ Time Frame: Up to six months ] [ Designated as safety issue: No ]
- ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas [ Time Frame: Up to six months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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.
Device: Testing Donor Specimens with ESA Chagas
Donors will be asked to return for a follow-up blood draw.
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.
|United States, Illinois|
|Rosemont, Illinois, United States, 60018|
|United States, Maryland|
|American Red Cross|
|Gaithersburg, Maryland, United States, 20877|
|Principal Investigator:||Susan Stramer, Ph.D.||American Red Cross|
|Principal Investigator:||Sharon Gordon, MS, MBA, MT||LifeSource|