Evaluation of Chagas Blood Screening and Confirmatory Assays

Evaluation of ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay

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.

Inclusion Criteria:

• Healthy donors that have consented to participate in study

Exclusion Criteria:

• N/A