Abbott ESA Chagas Assay Post-Market Study (ESA)

January 8, 2014 updated by: Abbott Diagnostics Division
The study is conducted to meet an FDA post market commitment to collect and report data on the performance of the ESA Chagas assay. A minimum of 50 donor specimens that are FDA-licensed ABBOTT PRISM Chagas repeatedly reactive (RR)will be tested with the ABBOTT ESA Chagas assay. In addition, minimum of 300 ABBOTT PRISM Chagas nonreactive (NR) unidentified donor specimens will be tested with ABBOTT ESA Chagas assay.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

ABBOTT ESA Chagas testing will be performed at a minimum of two blood donor centers. Testing will be performed using the FDA-licensed ESA Chagas assay and will be performed in accordance with the ESA Chagas package insert. ABBOTT PRISM Chagas repeatedly reactive blood donor specimens identified by U.S. blood donor centers, as part of the routine blood donation process, will be tested with the FDA-licensed ESA Chagas. Specimens will also be tested with radioimmune precipitation assay (RIPA) for antibody to T. cruzi, a laboratory developed test, and the FDA-licensed ORTHO T. cruzi ELISA. The donor centers will contact the donors and request the donor to return to complete a questionnaire and provide a follow-up specimen.

In addition, a minimum of 300 blood donor specimens with ABBOTT PRISM Chagas nonreactive results will also be tested with ESA Chagas. These specimens will be unidentified, leftover specimens from routine donor testing and not individually identifiable. Specimens that are positive or indeterminate with ESA Chagas will be further tested with RIPA.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Rosemont, Illinois, United States, 60018
        • LifeSource
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • American Red Cross

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

PRISM Chagas Repeatedly Reactive Donor Specimens

Inclusion Criteria:

  • Blood donor specimen documented as PRISM Chagas repeatedly reactive

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Testing Donor Specimens with ESA Chagas
Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.
Device: Testing Donor Specimens with ESA Chagas
Donors will be asked to return for a follow-up blood draw.
Other Names:
  • ABBOTT ESA Chagas (ESA Chagas) assay
  • List Number: 8L34

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas
Time Frame: Up to six months
Up to six months

Secondary Outcome Measures

Outcome Measure
Time Frame
ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas
Time Frame: Up to six months
Up to six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Diagnostics Division

Investigators

  • Principal Investigator: Susan Stramer, Ph.D., American National Red Cross
  • Principal Investigator: Sharon Gordon, MS, MBA, MT, LifeSource

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

August 8, 2012

First Submitted That Met QC Criteria

August 9, 2012

First Posted (ESTIMATE)

August 10, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 20, 2014

Last Update Submitted That Met QC Criteria

January 8, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7B5-02-10P02-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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