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Abbott ESA Chagas Assay Post-Market Study

NCT01662362 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2014-02-20

Study results available
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Summary

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.

Conditions

  • Chagas Disease

Interventions

DEVICE

Testing Donor Specimens with ESA Chagas

Donors will be asked to return for a follow-up blood draw.

Sponsors & Collaborators

  • Abbott Diagnostics Division

    lead INDUSTRY

Principal Investigators

  • Susan Stramer, Ph.D. · American National Red Cross

  • Sharon Gordon, MS, MBA, MT · LifeSource

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2012-12-31
Completion
2012-12-31

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 NCT01662362 on ClinicalTrials.gov