Abbott ESA Chagas Assay Post-Market Study

Not Applicable

Completed

• Conditions: Chagas Disease
• Interventions: Device: Testing Donor Specimens with ESA Chagas

• Registration Number: NCT01662362
• Lead Sponsor: Abbott Diagnostics Division

Brief Summary

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

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 Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-09
• Study First Posted: 2012-08-10
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-01
• Results First Submitted: 2014-01-08
• Results First Submitted QC: 2014-01-08
• Last Update Submitted: 2014-01-08
• Results First Posted: 2014-02-20
• Last Update Posted: 2014-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Blood donor specimen documented as PRISM Chagas repeatedly reactive

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Testing Donor Specimens with ESA Chagas	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.

Primary Outcome Measures

Name	Time	Method
ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas	Up to six months

Secondary Outcome Measures

Name	Time	Method
ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas	Up to six months

Trial Locations

Locations (2)

LifeSource; 🇺🇸 Rosemont, Illinois, United States

American Red Cross; 🇺🇸 Gaithersburg, Maryland, United States