Chagas Disease
Conditions
Keywords
Chagas Disease, Trypanosoma cruzi, American trypanosomiasis, South American trypanosomiasis, kissing bugs, reduviid bugs
Brief 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.
Detailed description
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.
Interventions
DEVICETesting Donor Specimens with ESA Chagas
Donors will be asked to return for a follow-up blood draw.
Sponsors
Abbott Diagnostics Division
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
PRISM Chagas Repeatedly Reactive Donor Specimens Inclusion Criteria: * Blood donor specimen documented as PRISM Chagas repeatedly reactive
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas | Up to six months |
Secondary
| Measure | Time frame |
|---|---|
| ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas | Up to six months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Testing Donor Specimens With ESA Chagas 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.
Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw. | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 38 |
Baseline characteristics
| Characteristic | Testing Donor Specimens With ESA Chagas |
|---|---|
| Age, Customized >= 18 years | 19 participants |
| Age, Customized Unknown | 44 participants |
| Region of Enrollment United States | 63 participants |
| Sex/Gender, Customized Female | 10 participants |
| Sex/Gender, Customized Male | 9 participants |
| Sex/Gender, Customized Unknown | 44 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 63 |
| serious Total, serious adverse events | 0 / 63 |
Outcome results
Primary
ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas
Time frame: Up to six months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Testing Donor Specimens With ESA Chagas | ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas | 92.06 percent agreement to RIPA |
Secondary
ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas
Time frame: Up to six months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Testing Donor Specimens With ESA Chagas | ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas | 99.00 percentage of specimens ESA negative |