NCT00718042

Evaluation of Chagas Blood Screening and Confirmatory Assays

Evaluation of ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41,862 (actual)
• Sponsor: Abbott Diagnostics Division · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Protocol designed to test blood samples from blood donors of whole blood and blood components using a new investigational screening test (PRISM Chagas) that detects antibody to T. cruzi (Chagas infection). Results will be compared to the current T. cruzi antibody screening assay. Specimens positive with the screening assay will be further tested with a new investigational Chagas confirmatory assay \[Enzyme Strip Assay (ESA) Chagas\]. Additional specimens collected under separate protocols or sourced from suppliers will also be provided to the clinical sites for testing with PRISM Chagas assay and ESA Chagas.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay	Test blood donor sample with ABBOTT PRISM Chagas assay. If results are reactive, donor sample will be tested with Chagas Confirmatory assay. Donors reactive with screening assay or positive with confirmatory assay will be deferred and asked to return for a follow-up blood draw.
DEVICE	ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay	Test blood donor sample with investigational Chagas assay. If results are reactive, donor samples will be tested with Chagas confirmatory assay. Donors reactive with screening assay or positive with confirmatory assay will be deferred and asked to return for a follow-up blood draw.

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-07-01
• Completion: 2009-09-01
• First posted: 2008-07-18
• Last updated: 2012-03-07
• Results posted: 2012-01-23

Locations

7 sites across 1 country: United States