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Abbott ESA Chagas Assay Post-Market Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Diagnostics Division
ClinicalTrials.gov Identifier:
NCT01662362
First received: August 8, 2012
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Chagas Disease
 Device: Testing Donor Specimens with ESA Chagas

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Abbott ESA Chagas Assay Post-Market Study

Resource links provided by NLM:

MedlinePlus related topics: Chagas Disease
U.S. FDA Resources

Further study details as provided by Abbott Diagnostics Division:

Primary Outcome Measures:
  • ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas [ Time Frame: Up to six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ESA testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas [ Time Frame: Up to six months ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: July 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

PRISM Chagas Repeatedly Reactive Donor Specimens

Inclusion Criteria:

  • Blood donor specimen documented as PRISM Chagas repeatedly reactive

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662362

Locations
United States, Illinois
LifeSource
Rosemont, Illinois, United States, 60018
United States, Maryland
American Red Cross
Gaithersburg, Maryland, United States, 20877
Sponsors and Collaborators
Abbott Diagnostics Division
Investigators
Principal Investigator: Susan Stramer, Ph.D. American Red Cross
Principal Investigator: Sharon Gordon, MS, MBA, MT LifeSource
  More Information

No publications provided

Responsible Party: Abbott Diagnostics Division
ClinicalTrials.gov Identifier: NCT01662362     History of Changes
Other Study ID Numbers: 7B5-02-10P02-01
Study First Received: August 8, 2012
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Diagnostics Division:
Chagas Disease
Trypanosoma cruzi
American trypanosomiasis
 South American trypanosomiasis
kissing bugs
reduviid bugs

Additional relevant MeSH terms:
Chagas Disease
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on May 16, 2013