Evaluation of Chagas Blood Screening and Confirmatory Assays

Abbott

Status: Completed

Conditions: Healthy

Treatments: Device: ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay

Study type: Interventional

Funder types: Industry

Identifiers

NCT00718042

7B5-02-06P06

Details and patient eligibility

About

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.

Enrollment: 41,862 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy donors that have consented to participate in study

Exclusion criteria

• N/A

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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41,862 participants in 2 patient groups

1

Experimental group

Description:

All subjects will have their blood tested by the investigational Chagas screening assay.

Treatment:

Device: ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay

Device: ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay

2

Experimental group

Description:

Testing of blood donor samples with the investigational Chagas screening assay. Samples that test positive will be also tested with the Chagas confirmatory assay.

Treatment:

Device: ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay

Device: ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay