At a glance
ClinicalIndex Comparison RecordN/ACompleted· 63 enrolled
Drug / intervention
Testing Donor Specimens with ESA Chagasdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Abbott ESA Chagas Assay Post-Market Study
In Brief
A clinical study evaluating Testing Donor Specimens with ESA Chagas for Chagas Disease. Completed, enrolled 63 participants across 2 sites.
Detailed Summary
The study is conducted to meet an FDA post market commitment to collect and report data on the performance of the ESA Chagas assay. A minimum of 50 donor specimens that are FDA-licensed ABBOTT PRISM Chagas repeatedly reactive (RR)will be tested with the ABBOTT ESA Chagas assay. In addition, minimum of 300 ABBOTT PRISM Chagas nonreactive (NR) unidentified donor specimens will be tested with ABBOTT ESA Chagas assay.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChagas Disease
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2012
First PostedAug 2012
Primary CompletionDec 2012
TodayJul 2026
First PostedAug 10, 2012
Enrollment StartJul 1, 2012
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.9 years ago
Interventions
Testing Donor Specimens with ESA Chagasdevice
Donors will be asked to return for a follow-up blood draw.