Evaluation of ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Diagnostics Division
- Enrollment
- 41,862
- Locations
- 14
- Primary Endpoint
- PRISM Chagas Specificity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy donors that have consented to participate in study
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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 \[radioimmune precipitation assay (RIPA)\].
PRISM Chagas Sensitivity
Time Frame: 6 months
Specimens from subjects known to be T cruzi parasite positive were tested with PRISM Chagas assay.
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.
ESA Chagas Sensitivity
Time Frame: 3 months
Specimens from individuals known to be T cruzi parasite positive were tested with ESA Chagas assay.
Secondary Outcomes
- 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)