Evaluation of Chagas Blood Screening and Confirmatory Assays

Completed · Not applicable

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00718042

Run by

Abbott Diagnostics Division

People needed

41862

Starts

2008-06-01

Expected to finish

2009-09-01

Last updated by the study team

2012-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy donors that have consented to participate in study

You may not qualify if…

• N/A

Where it is running

• BloodNet USA — Lakeland, Florida, United States
• Florida Blood Services — St. Petersburg, Florida, United States
• LifeSource Blood Center — Glenview, Illinois, United States
• American Red Cross Charlotte NTL — Charlotte, North Carolina, United States
• American Red Cross — Portland, Oregon, United States
• Rhode Island Blood Center — Providence, Rhode Island, United States
• South Texas Blood and Tissue Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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