Abbott ESA Chagas Assay Post-Market Study

Chagas Disease Clinical Trial

— ESA  

Official title:

Abbott ESA Chagas Assay Post-Market Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01662362
• Other study ID #: 7B5-02-10P02-01
• Status: Completed
• Phase: N/A
• First received: August 8, 2012
• Last updated: January 8, 2014
• Start date: July 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2014
• Source: Abbott Diagnostics Division
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years and older

Eligibility

PRISM Chagas Repeatedly Reactive Donor Specimens

Inclusion Criteria:

• Blood donor specimen documented as PRISM Chagas repeatedly reactive

Exclusion Criteria:

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chagas Disease

Intervention

Device:
• Testing Donor Specimens with ESA Chagas
Donors will be asked to return for a follow-up blood draw.

Locations

Country	Name	City	State
United States	American Red Cross	Gaithersburg	Maryland
United States	LifeSource	Rosemont	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Diagnostics Division

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas		Up to six months	No
Secondary	ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas		Up to six months	No