An interventional study of Testing Donor Specimens with ESA Chagas in Chagas Disease, sponsored by Abbott Diagnostics Division. Completed at 2 sites in United States. Open to participants aged 17 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-20.
Sponsored by Abbott Diagnostics Division (part of Abbott) · Not applicable and Interventional
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.
ABBOTT ESA Chagas testing will be performed at a minimum of two blood donor centers. Testing will be performed using the FDA-licensed ESA Chagas assay and will be performed in accordance with the ESA Chagas package insert. ABBOTT PRISM Chagas repeatedly reactive blood donor specimens identified by U.S. blood donor centers, as part of the routine blood donation process, will be tested with the FDA-licensed ESA Chagas. Specimens will also be tested with radioimmune precipitation assay (RIPA) for antibody to T. cruzi, a laboratory developed test, and the FDA-licensed ORTHO T. cruzi ELISA. The donor centers will contact the donors and request the donor to return to complete a questionnaire and provide a follow-up specimen.
In addition, a minimum of 300 blood donor specimens with ABBOTT PRISM Chagas nonreactive results will also be tested with ESA Chagas. These specimens will be unidentified, leftover specimens from routine donor testing and not individually identifiable. Specimens that are positive or indeterminate with ESA Chagas will be further tested with RIPA.
73 studies on the registry are indexed under Chagas Disease; 5 are open to participants now.
This study's enrollment of 63 is below the median of 87 across 49 interventional studies indexed under Chagas Disease.
Browse Chagas Disease studies →Abbott Diagnostics Division is the lead sponsor of 8 studies on the registry; none are open to participants now.
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PRISM Chagas Repeatedly Reactive Donor Specimens
Inclusion Criteria:
Exclusion Criteria:
Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.
Device: Testing Donor Specimens with ESA Chagas
Donors will be asked to return for a follow-up blood draw.
Also known as: ABBOTT ESA Chagas (ESA Chagas) assay, List Number: 8L34
ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas
Time frame: Up to six months
ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas
Time frame: Up to six months
| Milestone | Testing Donor Specimens With ESA Chagas |
|---|---|
| Started | 63 |
| Completed | 25 |
| Not completed | 38 |
| Withdrew: Lost to follow-up | 38 |
| percent agreement to RIPA | Testing Donor Specimens With ESA Chagas |
|---|---|
| ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas | 92.06 (82.44 to 97.37) |
| percentage of specimens ESA negative | Testing Donor Specimens With ESA Chagas |
|---|---|
| ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas | 99.00 (97.11 to 99.79) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Testing Donor Specimens With ESA Chagas | — | 0/63 (0%) | 0/63 (0%) |
Donor specimens PRISM Chagas Repeatly Reactive
| Age, Customized(participants) | Testing Donor Specimens With ESA Chagas |
|---|---|
| >= 18 years | 19 |
| Unknown | 44 |
| Sex/Gender, Customized(participants) | Testing Donor Specimens With ESA Chagas |
|---|---|
| Male | 9 |
| Female | 10 |
| Unknown | 44 |
| Region of Enrollment(participants) | Testing Donor Specimens With ESA Chagas |
|---|---|
| United States | 63 |
The record gives a start of Jul 2012, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2014, 1 year 2 months after primary completion.
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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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