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Evaluation of Chagas Blood Screening and Confirmatory Assays

NCT00718042 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41862

Last updated 2012-03-07

Study results available
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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

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.

Sponsors & Collaborators

  • Abbott Diagnostics Division

    lead INDUSTRY

Principal Investigators

  • Susan Stramer, PhD · American National Red Cross

  • Sharon Gordon · Lifesource

  • Norman Kalmin, MD · South Texas Blood and Tissue Center

  • Carolyn T Young, MD · Rhode Island Blood Center

  • Deborah Williams · Florida Blood Services

  • Pauline Simmonds-Brown · Blood Net USA

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-07-31
Completion
2009-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00718042 on ClinicalTrials.gov