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Completed

NCT Number: NCT01662362

Abbott ESA Chagas Assay Post-Market Study

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.

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Key information

Conditions

Chagas Disease Euglenozoa Infections Infections Parasitic Diseases Protozoan Infections Trypanosomiasis Vector Borne Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LifeSource, Rosemont, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

PRISM Chagas Repeatedly Reactive Donor Specimens

Inclusion criteria

  • Blood donor specimen documented as PRISM Chagas repeatedly reactive

Exclusion criteria

  • None

Treatment and study plan

Testing Donor Specimens with ESA Chagas

Device

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

Other names: ABBOTT ESA Chagas (ESA Chagas) assay, List Number: 8L34

Primary outcomes

  1. ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas

    Time frame: Up to six months

Secondary outcomes

  1. ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas

    Time frame: Up to six months

Sponsors and collaborators

Lead sponsor

Abbott Diagnostics Division

Industry

Registry information

Acronym: ESA

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 10, 2012
Registry last updated
Feb 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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