Abbott ESA Chagas Assay Post-Market Study (ESA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01662362|
Recruitment Status : Completed
First Posted : August 10, 2012
Results First Posted : February 20, 2014
Last Update Posted : February 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chagas Disease||Device: Testing Donor Specimens with ESA Chagas||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Abbott ESA Chagas Assay Post-Market Study|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
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.
- ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas [ Time Frame: Up to six months ]
- ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas [ Time Frame: Up to six months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01662362
|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 National Red Cross|
|Principal Investigator:||Sharon Gordon, MS, MBA, MT||LifeSource|