Abbott ESA Chagas Assay Post-Market Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Abbott ESA Chagas Assay Post-Market Study

Conditions
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Chagas Disease

Intervention / Treatment
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* Device: Testing Donor Specimens with ESA Chagas


Participation Criteria
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Eligibility Criteria
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PRISM Chagas Repeatedly Reactive Donor Specimens Inclusion Criteria: Blood donor specimen documented as PRISM Chagas repeatedly reactive Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Testing Donor Specimens with ESA Chagas<br>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<br>* Donors will be asked to return for a follow-up blood draw.<br>* Other names: List Number: 8L34;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas |  | Up to six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas |  | Up to six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chagas Disease, Trypanosoma cruzi, American trypanosomiasis, South American trypanosomiasis, kissing bugs, reduviid bugs