- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00718042
Evaluation of Chagas Blood Screening and Confirmatory Assays
March 2, 2012 updated by: Abbott Diagnostics Division
Evaluation of ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
41862
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Lakeland, Florida, United States, 33805
- BloodNet USA
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St. Petersburg, Florida, United States, 33716
- Florida Blood Services
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Illinois
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Glenview, Illinois, United States, 60025
- LifeSource Blood Center
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North Carolina
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Charlotte, North Carolina, United States, 28273
- American Red Cross Charlotte NTL
-
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Oregon
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Portland, Oregon, United States, 97220
- American Red Cross
-
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Rhode Island
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Providence, Rhode Island, United States, 02908
- Rhode Island Blood Center
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Texas
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San Antonio, Texas, United States, 78201
- South Texas Blood and Tissue Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy donors that have consented to participate in study
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
All subjects will have their blood tested by the investigational Chagas screening assay.
|
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.
Test blood donor sample with investigational Chagas assay.
If results are reactive, donor samples 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.
|
Experimental: 2
Testing of blood donor samples with the investigational Chagas screening assay.
Samples that test positive will be also tested with the Chagas confirmatory assay.
|
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.
Test blood donor sample with investigational Chagas assay.
If results are reactive, donor samples 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PRISM Chagas Specificity
Time Frame: 6 months
|
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
Time Frame: 6 months
|
Specimens from subjects known to be T cruzi parasite positive were tested with PRISM Chagas assay.
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6 months
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ESA Chagas Specificity
Time Frame: 3 months
|
Preselected US blood donor specimens (330) presumed T cruzi antibody negative negative that were tested only with the investigational ESA Chagas.
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3 months
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ESA Chagas Sensitivity
Time Frame: 3 months
|
Specimens from individuals known to be T cruzi parasite positive were tested with ESA Chagas assay.
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3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PRISM Chagas Reactivity Serology Positive Specimens
Time Frame: 4 months
|
Total of 85 specimens from subjects from South America known to be positive for T cruzi antibodies and 202 US blood donor specimens that were repeatedly reactive on a licensed test for antibodies to T cruzi were tested with the PRISM Chagas assay and supplemental testing (RIPA).
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4 months
|
PRISM Chagas Reactivity in Chagas Endemic Population
Time Frame: 2 months
|
Population of specimen collected in Chagas endemic area in South/Central America (524) were tested to demonstrate reactivity with the PRISM Chagas assay in a population with a 5% or greater prevalence of infection with T cruzi antibody.
specimens tested with PRISM Chagas assay and licensed test for T cruzi antibody and if repeatedly reactive with either assay the specimens were tested with supplemental assay (RIPA).
Data presented with PRISM Chagas and RIPA results.
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2 months
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ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas.
Time Frame: 15 months
|
A total of 41,760 US blood donor specimens were tested by ABBOTT PRISM Chagas.
Of these specimens, 58 out of 79 specimens were T cruzi antibody repeatedly reactive by ABBOTT PRISM Chagas (26 from 16,249 donor specimens tested in design validation phase and 32 from 25,511 specimens from the Chagas extended evaluation).
Donor specimens that were repeatedly reactive with the licensed T cruzi antibody assay, but PRISM Chagas nonreactive (6) and specimens PRISM Chagas grayzone negative (15) were excluded from this analysis.
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15 months
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ESA Chagas Sensitivity in Serologically Positive Non-US Specimens
Time Frame: 3 months
|
ESA Chagas Sensitivity in a non-US population was determined for the 85 out of the total 287 serologically positive specimens (202 US Serology Positive specimens were excluded).
These specimens were collected from individuals positive for T cruzi antibodies based on 2 different serologic tests for antibodies to T cruzi in Argentina and were tested with ESA Chagas.
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3 months
|
ESA Chagas Testing in Chagas Endemic Population
Time Frame: 2 months
|
Specimen collected in Chagas endemic areas in South or Central America (524) tested with ESA Chagas and licensed test for T cruzi antibody.
Specimens repeatedly reactive with either screening assay and/or ESA Chagas positive were tested with supplemental assay (RIPA).
Presentation of ESA Chagas results for 132 specimens from a Chagas endemic population that were RIPA positive.
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2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
July 16, 2008
First Submitted That Met QC Criteria
July 16, 2008
First Posted (Estimate)
July 18, 2008
Study Record Updates
Last Update Posted (Estimate)
March 7, 2012
Last Update Submitted That Met QC Criteria
March 2, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 7B5-02-06P06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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