Evaluation of Chagas Blood Screening and Confirmatory Assays
Evaluation of ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay
1 other identifier
interventional
41,862
1 country
7
Brief Summary
Protocol designed to test blood samples from blood donors of whole blood and blood components using a new investigational screening test (PRISM Chagas) that detects antibody to T. cruzi (Chagas infection). Results will be compared to the current T. cruzi antibody screening assay. Specimens positive with the screening assay will be further tested with a new investigational Chagas confirmatory assay \[Enzyme Strip Assay (ESA) Chagas\]. Additional specimens collected under separate protocols or sourced from suppliers will also be provided to the clinical sites for testing with PRISM Chagas assay and ESA Chagas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Jun 2008
Typical duration for not_applicable healthy
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 16, 2008
CompletedFirst Posted
Study publicly available on registry
July 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
January 23, 2012
CompletedMarch 7, 2012
February 1, 2012
1.1 years
July 16, 2008
December 16, 2011
March 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
PRISM Chagas Specificity
Total of 16,249 serum and plasma blood donor specimens tested with PRISM Chagas assay during design validation phase. Repeatedly reactive specimens were tested further with a supplemental assay \[radioimmune precipitation assay (RIPA)\].
6 months
PRISM Chagas Sensitivity
Specimens from subjects known to be T cruzi parasite positive were tested with PRISM Chagas assay.
6 months
ESA Chagas Specificity
Preselected US blood donor specimens (330) presumed T cruzi antibody negative negative that were tested only with the investigational ESA Chagas.
3 months
ESA Chagas Sensitivity
Specimens from individuals known to be T cruzi parasite positive were tested with ESA Chagas assay.
3 months
Secondary Outcomes (5)
PRISM Chagas Reactivity Serology Positive Specimens
4 months
PRISM Chagas Reactivity in Chagas Endemic Population
2 months
ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas.
15 months
ESA Chagas Sensitivity in Serologically Positive Non-US Specimens
3 months
ESA Chagas Testing in Chagas Endemic Population
2 months
Study Arms (2)
1
EXPERIMENTALAll subjects will have their blood tested by the investigational Chagas screening assay.
2
EXPERIMENTALTesting of blood donor samples with the investigational Chagas screening assay. Samples that test positive will be also tested with the Chagas confirmatory assay.
Interventions
Test blood donor sample with ABBOTT PRISM Chagas assay. If results are reactive, donor sample will be tested with Chagas Confirmatory assay. Donors reactive with screening assay or positive with confirmatory assay will be deferred and asked to return for a follow-up blood draw.
Eligibility Criteria
You may qualify if:
- Healthy donors that have consented to participate in study
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
BloodNet USA
Lakeland, Florida, 33805, United States
Florida Blood Services
St. Petersburg, Florida, 33716, United States
LifeSource Blood Center
Glenview, Illinois, 60025, United States
American Red Cross Charlotte NTL
Charlotte, North Carolina, 28273, United States
American Red Cross
Portland, Oregon, 97220, United States
Rhode Island Blood Center
Providence, Rhode Island, 02908, United States
South Texas Blood and Tissue Center
San Antonio, Texas, 78201, United States
Results Point of Contact
- Title
- Associate Director Clincal Affairs
- Organization
- Abbott Laboratories
Study Officials
- PRINCIPAL INVESTIGATOR
Susan Stramer, PhD
American National Red Cross
- PRINCIPAL INVESTIGATOR
Sharon Gordon
Lifesource
- PRINCIPAL INVESTIGATOR
Norman Kalmin, MD
South Texas Blood and Tissue Center
- PRINCIPAL INVESTIGATOR
Carolyn T Young, MD
Rhode Island Blood Center
- PRINCIPAL INVESTIGATOR
Deborah Williams
Florida Blood Services
- PRINCIPAL INVESTIGATOR
Pauline Simmonds-Brown
Blood Net USA
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2008
First Posted
July 18, 2008
Study Start
June 1, 2008
Primary Completion
July 1, 2009
Study Completion
September 1, 2009
Last Updated
March 7, 2012
Results First Posted
January 23, 2012
Record last verified: 2012-02