Abbott ESA Chagas Assay Post-Market Study

Completed · Not applicable

Conditions studied: Chagas Disease

In brief

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.

Key facts

Study ID

NCT01662362

Run by

Abbott Diagnostics Division

People needed

63

Starts

2012-07-01

Expected to finish

2012-12-01

Last updated by the study team

2014-02-20

Who can join

Age: 17 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Blood donor specimen documented as PRISM Chagas repeatedly reactive

You may not qualify if…

• None

Where it is running

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

Full record on ClinicalTrials.gov

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