N/A N=63

Abbott ESA Chagas Assay Post-Market Study

Chagas Disease

Bottom Line

View on ClinicalTrials.gov: NCT01662362 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2014

Primary outcome: Primary: ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas — 92.06 percent agreement to RIPA

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Testing Donor Specimens with ESA Chagas (Device)
Age: Pediatric, Adult, Older Adult · 17+ yrs
Sex: All
Sponsor: Abbott Diagnostics Division
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas	92.06	—
SECONDARY ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas	99.00	—

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.

Eligibility Criteria

PRISM Chagas Repeatedly Reactive Donor Specimens

Inclusion Criteria

Blood donor specimen documented as PRISM Chagas repeatedly reactive

Exclusion Criteria

None

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01662362). 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.