N/A
N=42,786
Evaluation of Chagas Blood Screening and Confirmatory Assays
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00718042 ↗Enrolled (actual)
42,786
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcome: Primary: PRISM Chagas Specificity — 23; 16223; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Diagnostics Division
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PRISM Chagas Specificity |
23; 16223; 3 | — |
| PRIMARY PRISM Chagas Sensitivity |
0; 110 | — |
| PRIMARY ESA Chagas Specificity |
327; 3; 0 | — |
| PRIMARY ESA Chagas Sensitivity |
110; 0 | — |
| SECONDARY PRISM Chagas Reactivity Serology Positive Specimens |
224; 24; 39; 0 | — |
| SECONDARY PRISM Chagas Reactivity in Chagas Endemic Population |
129; 5; 3; 2; 385; 0 | — |
| SECONDARY ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas. |
9; 49 | — |
| SECONDARY ESA Chagas Sensitivity in Serologically Positive Non-US Specimens |
85; 0 | — |
| SECONDARY ESA Chagas Testing in Chagas Endemic Population |
130; 2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy donors that have consented to participate in study
Exclusion Criteria
- N/A
Data sourced from ClinicalTrials.gov (NCT00718042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.