Abbott ESA Chagas Assay Post-Market Study

NCT ID: NCT01662362

Last Updated: 2014-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2012-12-31

Brief 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.

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.

Conditions

Chagas Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Testing Donor Specimens with ESA Chagas

Intervention Type: DEVICE

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

Interventions

Testing Donor Specimens with ESA Chagas

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

Intervention Type: DEVICE

Other Intervention Names

ABBOTT ESA Chagas (ESA Chagas) assay; List Number: 8L34

Eligibility Criteria

Inclusion Criteria

• Blood donor specimen documented as PRISM Chagas repeatedly reactive

Exclusion Criteria

• None

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott Diagnostics Division

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Stramer, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

American National Red Cross

Sharon Gordon, MS, MBA, MT

Role: PRINCIPAL_INVESTIGATOR

LifeSource

Locations

LifeSource

Rosemont, Illinois, United States

American Red Cross

Gaithersburg, Maryland, United States

Countries

United States

Other Identifiers

7B5-02-10P02-01

Identifier Type: -

Identifier Source: org_study_id