Evaluation of Chagas Blood Screening and Confirmatory Assays - Full Text View

Purpose

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.

Condition	Intervention
Healthy	Device: ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening
Official Title:	Evaluation of ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay

Resource links provided by NLM:

MedlinePlus related topics: Blood Transfusion and Donation

U.S. FDA Resources

Further study details as provided by Abbott Diagnostics Division:

Primary Outcome Measures:

PRISM Chagas Specificity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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)].
PRISM Chagas Sensitivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Specimens from subjects known to be T cruzi parasite positive were tested with PRISM Chagas assay.
ESA Chagas Specificity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Preselected US blood donor specimens (330) presumed T cruzi antibody negative negative that were tested only with the investigational ESA Chagas.
ESA Chagas Sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Specimens from individuals known to be T cruzi parasite positive were tested with ESA Chagas assay.

Secondary Outcome Measures:

PRISM Chagas Reactivity Serology Positive Specimens [ Time Frame: 4 months ] [ Designated as safety issue: No ]
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).
PRISM Chagas Reactivity in Chagas Endemic Population [ Time Frame: 2 months ] [ Designated as safety issue: No ]
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.
ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas. [ Time Frame: 15 months ] [ Designated as safety issue: No ]
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.
ESA Chagas Sensitivity in Serologically Positive Non-US Specimens [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.
ESA Chagas Testing in Chagas Endemic Population [ Time Frame: 2 months ] [ Designated as safety issue: No ]
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.

Enrollment:	41862
Study Start Date:	June 2008
Study Completion Date:	September 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 All subjects will have their blood tested by the investigational Chagas screening assay.	Device: ABBOTT PRISM Chagas Assay and 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.
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.	Device: ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy donors that have consented to participate in study

Exclusion Criteria:

N/A

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718042

Locations

United States, Florida
BloodNet USA
Lakeland, Florida, United States, 33805
Florida Blood Services
St. Petersburg, Florida, United States, 33716
United States, Illinois
LifeSource Blood Center
Glenview, Illinois, United States, 60025
United States, North Carolina
American Red Cross Charlotte NTL
Charlotte, North Carolina, United States, 28273
United States, Oregon
American Red Cross
Portland, Oregon, United States, 97220
United States, Rhode Island
Rhode Island Blood Center
Providence, Rhode Island, United States, 02908
United States, Texas
South Texas Blood and Tissue Center
San Antonio, Texas, United States, 78201

Sponsors and Collaborators

Abbott Diagnostics Division

Investigators

Principal Investigator:	Susan Stramer, PhD	American 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

More Information

No publications provided

Responsible Party:	Abbott Diagnostics Division
ClinicalTrials.gov Identifier:	NCT00718042 History of Changes
Other Study ID Numbers:	7B5-02-06P06
Study First Received:	July 16, 2008
Results First Received:	December 16, 2011
Last Updated:	March 2, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott Diagnostics Division:

healthy donors

ClinicalTrials.gov processed this record on May 19, 2013