CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 41,862 enrolled
Drug / intervention
ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00718042
NCT00718042N/ACompleted
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Evaluation of ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay

Abbott Diagnostics Division·interventional·Posted Jul 18, 2008·Updated Mar 7, 2012

In Brief

A clinical study evaluating ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay for Healthy. Completed, enrolled 41,862 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 18, 2008
Enrollment StartJun 1, 2008
Primary CompletionJul 1, 2009
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.0 years ago

Interventions

ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assaydevice

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.

ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assaydevice

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.