An interventional study of ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay and ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay in Healthy, sponsored by Abbott Diagnostics Division. Completed at 7 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-07.
Sponsored by Abbott Diagnostics Division (part of Abbott) · Not applicable, Interventional, and Screening
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.
Abbott Diagnostics Division is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
All subjects will have their blood tested by the investigational Chagas screening assay.
Device: ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay
Testing of blood donor samples with the investigational Chagas screening assay. Samples that test positive will be also tested with the Chagas confirmatory assay.
Device: ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay
Test blood donor sample with ABBOTT PRISM Chagas assay. If results are reactive, donor sample will be tested with Chagas Confirmatory assay. Donors reactive with screening assay or positive with confirmatory assay will be deferred and asked to return for a follow-up blood draw.
Test blood donor sample with investigational Chagas assay. If results are reactive, donor samples will be tested with Chagas confirmatory assay. Donors reactive with screening assay or positive with confirmatory assay will be deferred and asked to return for a follow-up blood draw.
PRISM Chagas Specificity
Total of 16,249 serum and plasma blood donor specimens tested with PRISM Chagas assay during design validation phase. Repeatedly reactive specimens were tested further with a supplemental assay \[radioimmune precipitation assay (RIPA)\].
Time frame: 6 months
PRISM Chagas Sensitivity
Specimens from subjects known to be T cruzi parasite positive were tested with PRISM Chagas assay.
Time frame: 6 months
ESA Chagas Specificity
Preselected US blood donor specimens (330) presumed T cruzi antibody negative negative that were tested only with the investigational ESA Chagas.
Time frame: 3 months
ESA Chagas Sensitivity
Specimens from individuals known to be T cruzi parasite positive were tested with ESA Chagas assay.
Time frame: 3 months
PRISM Chagas Reactivity Serology Positive Specimens
Total of 85 specimens from subjects from South America known to be positive for T cruzi antibodies and 202 US blood donor specimens that were repeatedly reactive on a licensed test for antibodies to T cruzi were tested with the PRISM Chagas assay and supplemental testing (RIPA).
Time frame: 4 months
PRISM Chagas Reactivity in Chagas Endemic Population
Population of specimen collected in Chagas endemic area in South/Central America (524) were tested to demonstrate reactivity with the PRISM Chagas assay in a population with a 5% or greater prevalence of infection with T cruzi antibody. specimens tested with PRISM Chagas assay and licensed test for T cruzi antibody and if repeatedly reactive with either assay the specimens were tested with supplemental assay (RIPA). Data presented with PRISM Chagas and RIPA results.
Time frame: 2 months
ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas.
A total of 41,760 US blood donor specimens were tested by ABBOTT PRISM Chagas. Of these specimens, 58 out of 79 specimens were T cruzi antibody repeatedly reactive by ABBOTT PRISM Chagas (26 from 16,249 donor specimens tested in design validation phase and 32 from 25,511 specimens from the Chagas extended evaluation). Donor specimens that were repeatedly reactive with the licensed T cruzi antibody assay, but PRISM Chagas nonreactive (6) and specimens PRISM Chagas grayzone negative (15) were excluded from this analysis.
Time frame: 15 months
ESA Chagas Sensitivity in Serologically Positive Non-US Specimens
ESA Chagas Sensitivity in a non-US population was determined for the 85 out of the total 287 serologically positive specimens (202 US Serology Positive specimens were excluded). These specimens were collected from individuals positive for T cruzi antibodies based on 2 different serologic tests for antibodies to T cruzi in Argentina and were tested with ESA Chagas.
Time frame: 3 months
ESA Chagas Testing in Chagas Endemic Population
Specimen collected in Chagas endemic areas in South or Central America (524) tested with ESA Chagas and licensed test for T cruzi antibody. Specimens repeatedly reactive with either screening assay and/or ESA Chagas positive were tested with supplemental assay (RIPA). Presentation of ESA Chagas results for 132 specimens from a Chagas endemic population that were RIPA positive.
Time frame: 2 months
US blood donors specimens collected as part of routine blood donation (Specificity: 16313, Extended: 25549). Additional specimens included: 204 T cruzi antibody positive US blood donor; 110 parasite positive, 85 antibody positive, 525 Chagas endemic; and 330 unidentified US blood donor presumed T cruzi antibody negative were provided by Abbott.
| Milestone | ABBOTT PRISM Chagas Specificity | Reactivity T Cruzi Antibody Positive | Reactivity in Chagas Endemic Population | Sensitivity Chagas Parasitology Positive Specimens | Chagas Extended Evaluation | ESA Chagas Specificity |
|---|---|---|---|---|---|---|
| Started | 16313 | 289 | 525 | 110 | 25549 | 0 |
| Completed | 16249 | 287 | 524 | 110 | 25511 | 0 |
| Not completed | 64 | 2 | 1 | 0 | 38 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 2 | 0 |
| Withdrew: Protocol violation | 64 | 0 | 0 | 0 | 36 | 0 |
| Withdrew: Insufficient sample | 0 | 1 | 1 | 0 | 0 | 0 |
| Withdrew: No result on comparator assay | 0 | 1 | 0 | 0 | 0 | 0 |
| Milestone | ABBOTT PRISM Chagas Specificity | Reactivity T Cruzi Antibody Positive | Reactivity in Chagas Endemic Population | Sensitivity Chagas Parasitology Positive Specimens | Chagas Extended Evaluation | ESA Chagas Specificity |
|---|---|---|---|---|---|---|
| Started | 36 | 287 | 524 | 110 | 43 | 330 |
| Completed | 36 | 287 | 524 | 110 | 43 | 330 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | ABBOTT PRISM Chagas Specificity | Reactivity T Cruzi Antibody Positive | Reactivity in Chagas Endemic Population | Sensitivity Chagas Parasitology Positive Specimens | Chagas Extended Evaluation | ESA Chagas Specificity |
|---|---|---|---|---|---|---|
| Started | 36 | 0 | 0 | 0 | 43 | 0 |
| Completed | 23 | 0 | 0 | 0 | 24 | 0 |
| Not completed | 13 | 0 | 0 | 0 | 19 | 0 |
| Withdrew: Lost to follow-up | 13 | 0 | 0 | 0 | 19 | 0 |
Total of 16,249 serum and plasma blood donor specimens tested with PRISM Chagas assay during design validation phase. Repeatedly reactive specimens were tested further with a supplemental assay \[radioimmune precipitation assay (RIPA)\].
| participants | ABBOTT PRISM Chagas Specificity |
|---|---|
| PRISM Chagas Reactive, RIPA Negative | 23 |
| PRISM Chagas Nonreactive | 16223 |
| PRISM Chagas Reactive, RIPA Positive | 3 |
Total of 85 specimens from subjects from South America known to be positive for T cruzi antibodies and 202 US blood donor specimens that were repeatedly reactive on a licensed test for antibodies to T cruzi were tested with the PRISM Chagas assay and supplemental testing (RIPA).
| participants | Reactivity T Cruzi Antibody Positive |
|---|---|
| PRISM Chagas Reactive, RIPA Positive | 224 |
| PRISM Chagas Reactive, RIPA Negative | 24 |
| PRISM Chagas Nonreactive, RIPA Negative | 39 |
| PRISM Chagas Nonreactive, RIPA Positive | 0 |
Specimens from subjects known to be T cruzi parasite positive were tested with PRISM Chagas assay.
| participants | Sensitivity Chagas Parasitology Positive Specimens |
|---|---|
| PRISM Chagas Nonreactive | 0 |
| PRISM Chagas Reactive, Parasite Positive | 110 |
Population of specimen collected in Chagas endemic area in South/Central America (524) were tested to demonstrate reactivity with the PRISM Chagas assay in a population with a 5% or greater prevalence of infection with T cruzi antibody. specimens tested with PRISM Chagas assay and licensed test for T cruzi antibody and if repeatedly reactive with either assay the specimens were tested with supplemental assay (RIPA). Data presented with PRISM Chagas and RIPA results.
| participants | PRISM Chagas Reactivity Endemic Population |
|---|---|
| PRISM Chagas Reactive, RIPA Positive | 129 |
| PRISM Chagas Reactive, RIPA Negative | 5 |
| PRISM Chagas Reactive, RIPA Indeterminate | 3 |
| PRISM Chagas Nonreactive, RIPA Positive | 2 |
| PRISM Chagas Nonreactive, RIPA Negative | 385 |
| PRISM Chagas Nonreactive, RIPA Indeterminate | 0 |
A total of 41,760 US blood donor specimens were tested by ABBOTT PRISM Chagas. Of these specimens, 58 out of 79 specimens were T cruzi antibody repeatedly reactive by ABBOTT PRISM Chagas (26 from 16,249 donor specimens tested in design validation phase and 32 from 25,511 specimens from the Chagas extended evaluation). Donor specimens that were repeatedly reactive with the licensed T cruzi antibody assay, but PRISM Chagas nonreactive (6) and specimens PRISM Chagas grayzone negative (15) were excluded from this analysis.
| participants | ESA Chagas US Donor Specimen Testing |
|---|---|
| ESA Chagas Positive, RIPA Positive | 9 |
| ESA Chagas Positive, RIPA Negative | 49 |
Preselected US blood donor specimens (330) presumed T cruzi antibody negative negative that were tested only with the investigational ESA Chagas.
| participants | ESA Chagas Specificity |
|---|---|
| ESA Chagas Negative | 327 |
| ESA Chagas Indeterminate | 3 |
| ESA Chagas Positive | 0 |
Specimens from individuals known to be T cruzi parasite positive were tested with ESA Chagas assay.
| participants | Sensitivity Chagas Parasitology Positive Specimens |
|---|---|
| ESA Chagas Positive | 110 |
| ESA Chagas Negative | 0 |
ESA Chagas Sensitivity in a non-US population was determined for the 85 out of the total 287 serologically positive specimens (202 US Serology Positive specimens were excluded). These specimens were collected from individuals positive for T cruzi antibodies based on 2 different serologic tests for antibodies to T cruzi in Argentina and were tested with ESA Chagas.
| participants | ESA Chagas Non-US Serologically Positive |
|---|---|
| ESA Chagas Positve | 85 |
| ESA Chagas Negative | 0 |
Specimen collected in Chagas endemic areas in South or Central America (524) tested with ESA Chagas and licensed test for T cruzi antibody. Specimens repeatedly reactive with either screening assay and/or ESA Chagas positive were tested with supplemental assay (RIPA). Presentation of ESA Chagas results for 132 specimens from a Chagas endemic population that were RIPA positive.
| participants | Reactivity in Chagas Endemic Population |
|---|---|
| ESA Chagas Postive, RIPA Positive | 130 |
| ESA Chagas Indeterminate, RIPA Positive | 2 |
Collected over Adverse event data collected during donor follow-up collection for period of 10 months. Donors reactive with screening assay or positive with confirmatory assay will be deferred and asked to return for a follow-up blood draw.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Donor Follow-up Specimen Collection | — | 0/47 (0%) | 0/47 (0%) |
| Age, Customized(Participants) | ABBOTT PRISM Chagas Specificity | Reactivity T Cruzi Antibody Positive | Reactivity in Chagas Endemic Population | ESA Chagas Specificity | Sensitivity Chagas Parasitology Positive Specimens | Chagas Extended Evaluation | Total |
|---|---|---|---|---|---|---|---|
| >= 18 years | 16313 | 85 | 525 | 330 | 110 | 25549 | 42912 |
| Not Collected | 0 | 204 | 0 | 0 | 0 | 0 | 204 |
| Sex/Gender, Customized(Participant) | ABBOTT PRISM Chagas Specificity | Reactivity T Cruzi Antibody Positive | Reactivity in Chagas Endemic Population | ESA Chagas Specificity | Sensitivity Chagas Parasitology Positive Specimens | Chagas Extended Evaluation | Total |
|---|---|---|---|---|---|---|---|
| Female | 0 | 44 | 336 | 0 | 53 | 0 | 433 |
| Male | 0 | 41 | 189 | 0 | 57 | 0 | 287 |
| Not Collected | 16313 | 204 | 0 | 330 | 0 | 25549 | 42396 |
| Region of Enrollment(participants) | ABBOTT PRISM Chagas Specificity | Reactivity T Cruzi Antibody Positive | Reactivity in Chagas Endemic Population | ESA Chagas Specificity | Sensitivity Chagas Parasitology Positive Specimens | Chagas Extended Evaluation | Total |
|---|---|---|---|---|---|---|---|
| United States | 16313 | 204 | 0 | 330 | 0 | 25549 | 42396 |
| Argentina | 0 | 85 | 176 | 0 | 76 | 0 | 337 |
| Brazil | 0 | 0 | 50 | 0 | 7 | 0 | 57 |
| Guatemala | 0 | 0 | 149 | 0 | 0 | 0 | 149 |
| Panama | 0 | 0 | 50 | 0 | 0 | 0 | 50 |
| Peru | 0 | 0 | 100 | 0 | 5 | 0 | 105 |
| Bolivia | 0 | 0 | 0 | 0 | 22 | 0 | 22 |
The record gives a start of Jun 2008, a primary completion of Jul 2009 and a completion of Sep 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2012, 2 years 6 months after primary completion.
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This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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