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NCT00718042 · ClinicalTrials.gov registry record · NA

Evaluation of Chagas Blood Screening and Confirmatory Assays

A NA study of Healthy, sponsored by Abbott Diagnostics Division.

Completed
Registry status
NA
Development phase
41,862
Enrollment target
7
Study locations

NCT00718042: Completed NA study of Healthy, sponsored by Abbott Diagnostics Division.

NCT00718042 is a NA study of Healthy that has completed, run by Abbott Diagnostics Division. The registered enrollment target is 41,862 participants, above the 609-participant average among 1,090 other Healthy trials with a reported enrollment target (6774% higher). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00718042, a NA study of Healthy, has completed, sponsored by Abbott Diagnostics Division.

COMPLETED
Registry status
NA
Development phase
41,862 participants
Enrollment target
7
Study locations

Study 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.

Primary Outcome

Total of 16,249 serum and plasma blood donor specimens tested with PRISM Chagas assay during design validation phase. Repeatedly reactive specimens were tested further with a supplemental assay \[radioimmune precipitation assay (RIPA)\].

Conditions Studied

Healthy

Interventions

  • DEVICE ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay

Study Locations (7)

Florida

  • BloodNet USA - Lakeland
  • Florida Blood Services - St. Petersburg

Illinois

  • LifeSource Blood Center - Glenview

North Carolina

  • American Red Cross Charlotte NTL - Charlotte

Oregon

  • American Red Cross - Portland

Rhode Island

  • Rhode Island Blood Center - Providence

Texas

  • South Texas Blood and Tissue Center - San Antonio

Trial Details

FieldValue
Enrollment Target 41,862 participants
Start Date 2008-06
Est. Completion 2009-09
Phase NA
Abbott Diagnostics Division

7 total trials

What the finished NCT00718042 record still lists

NCT00718042 is an interventional study that assigns participants to a tested intervention. Its 41,862 participants enrollment target places it among the larger protocols in the corpus, above the 609-participant average among 1,090 other Healthy trials with a reported enrollment target (6774% higher).

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay is the first listed.

NCT00718042 lists 7 locations in 6 states (Florida, Illinois, North Carolina).

Frequently Asked Questions

What is clinical trial NCT00718042 about?

NCT00718042 is a clinical study titled "Evaluation of Chagas Blood Screening and Confirmatory Assays". 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 ...

What is the current status of trial NCT00718042?

This trial is currently completed. It is a NA study. The enrollment target is 41,862 participants. The study started on 2008-06. Estimated completion is 2009-09.

What conditions does trial NCT00718042 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT00718042?

The interventions under investigation include: ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay (DEVICE).

Who is sponsoring clinical trial NCT00718042?

This trial is sponsored by Abbott Diagnostics Division, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00718042 being conducted?

This trial has 7 study locations across Florida, Illinois, North Carolina, Oregon, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Healthy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00718042's enrollment target sits among peer trials

41,862 5th of 1090 higher than 1,086 of 1,090 other Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00718042, the US trial registry maintained by the National Library of Medicine. NCT00718042 (large enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.