Healthy
Conditions
Keywords
healthy donors
Brief summary
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.
Interventions
DEVICEABBOTT 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.
Sponsors
Abbott Diagnostics Division
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy donors that have consented to participate in study
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PRISM Chagas Specificity | 6 months | 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 \[radioimmune precipitation assay (RIPA)\]. |
| PRISM Chagas Sensitivity | 6 months | Specimens from subjects known to be T cruzi parasite positive were tested with PRISM Chagas assay. |
| ESA Chagas Specificity | 3 months | Preselected US blood donor specimens (330) presumed T cruzi antibody negative negative that were tested only with the investigational ESA Chagas. |
| ESA Chagas Sensitivity | 3 months | Specimens from individuals known to be T cruzi parasite positive were tested with ESA Chagas assay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PRISM Chagas Reactivity Serology Positive Specimens | 4 months | 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). |
| ESA Chagas Testing in Chagas Endemic Population | 2 months | 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. |
| PRISM Chagas Reactivity in Chagas Endemic Population | 2 months | 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. |
| ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas. | 15 months | 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. |
| ESA Chagas Sensitivity in Serologically Positive Non-US Specimens | 3 months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
All subjects were assigned to one group and tested with the PRISM Chagas assay. There were no pre-screening criteria. Specimens repeatedly reactive with the screening assay were further evaluated with ESA Chagas. The 330 unidentified US blood donor specimens presumed T cruzi antibody negative were only tested with ESA Chagas.
Participants by arm
| Arm | Count |
|---|---|
| ABBOTT PRISM Chagas Specificity All subject's blood tested by the investigational Chagas screening test. | 16,313 |
| Reactivity T Cruzi Antibody Positive Specimen antibody positive for T cruzi antibody collected in South America (85) under separate specimen collection protocols and unidentified US blood donor specimens (202) were tested with investigational Chagas screening assay and with the Chagas confirmatory assay. | 289 |
| Reactivity in Chagas Endemic Population Specimen collected in Chagas endemic area in South/Central America (524) under separate specimen collection protocol were tested with investigational Chagas screening assay and with the Chagas Confirmatory assay. | 525 |
| ESA Chagas Specificity US blood donor specimen presumed antibody negative for T cruzi antibody were tested with investigational ESA Chagas. | 330 |
| Sensitivity Chagas Parasitology Positive Specimens Specimen collected in South/Central America under separate specimen collection protocols were tested with investigational Chagas screening assay and with ESA Chagas. | 110 |
| Chagas Extended Evaluation All subject's blood tested by the investigational Chagas screening test. | 25,549 |
| Total | 43,116 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| ABBOTT PRISM Chagas Testing | Insufficient sample | 0 | 1 | 1 | 0 | 0 | 0 |
| ABBOTT PRISM Chagas Testing | No result on comparator assay | 0 | 1 | 0 | 0 | 0 | 0 |
| ABBOTT PRISM Chagas Testing | Protocol Violation | 64 | 0 | 0 | 0 | 36 | 0 |
| ABBOTT PRISM Chagas Testing | Withdrawal by Subject | 0 | 0 | 0 | 0 | 2 | 0 |
| Donor Follow-up | Lost to Follow-up | 13 | 0 | 0 | 0 | 19 | 0 |
Baseline characteristics
| Characteristic | ESA Chagas Specificity | Sensitivity Chagas Parasitology Positive Specimens | Chagas Extended Evaluation | Total | ABBOTT PRISM Chagas Specificity | Reactivity T Cruzi Antibody Positive | Reactivity in Chagas Endemic Population |
|---|---|---|---|---|---|---|---|
| Age, Customized >= 18 years | 330 Participants | 110 Participants | 25549 Participants | 42912 Participants | 16313 Participants | 85 Participants | 525 Participants |
| Age, Customized Not Collected | 0 Participants | 0 Participants | 0 Participants | 204 Participants | 0 Participants | 204 Participants | 0 Participants |
| Region of Enrollment Argentina | 0 participants | 76 participants | 0 participants | 337 participants | 0 participants | 85 participants | 176 participants |
| Region of Enrollment Bolivia | 0 participants | 22 participants | 0 participants | 22 participants | 0 participants | 0 participants | 0 participants |
| Region of Enrollment Brazil | 0 participants | 7 participants | 0 participants | 57 participants | 0 participants | 0 participants | 50 participants |
| Region of Enrollment Guatemala | 0 participants | 0 participants | 0 participants | 149 participants | 0 participants | 0 participants | 149 participants |
| Region of Enrollment Panama | 0 participants | 0 participants | 0 participants | 50 participants | 0 participants | 0 participants | 50 participants |
| Region of Enrollment Peru | 0 participants | 5 participants | 0 participants | 105 participants | 0 participants | 0 participants | 100 participants |
| Region of Enrollment United States | 330 participants | 0 participants | 25549 participants | 42396 participants | 16313 participants | 204 participants | 0 participants |
| Sex/Gender, Customized Female | 0 Participant | 53 Participant | 0 Participant | 433 Participant | 0 Participant | 44 Participant | 336 Participant |
| Sex/Gender, Customized Male | 0 Participant | 57 Participant | 0 Participant | 287 Participant | 0 Participant | 41 Participant | 189 Participant |
| Sex/Gender, Customized Not Collected | 330 Participant | 0 Participant | 25549 Participant | 42396 Participant | 16313 Participant | 204 Participant | 0 Participant |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 |
Outcome results
Primary
ESA Chagas Sensitivity
Specimens from individuals known to be T cruzi parasite positive were tested with ESA Chagas assay.
Time frame: 3 months
Population: Specimens from 110 subjects known to be positive for T cruzi parasite tested with ESA Chagas per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABBOTT PRISM Chagas Specificity | ESA Chagas Sensitivity | ESA Chagas Positive | 110 participants |
| ABBOTT PRISM Chagas Specificity | ESA Chagas Sensitivity | ESA Chagas Negative | 0 participants |
Primary
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
Population: Determine percentage of donor specimens ESA Chagas negative in a presumed negative population per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABBOTT PRISM Chagas Specificity | ESA Chagas Specificity | ESA Chagas Positive | 0 participants |
| ABBOTT PRISM Chagas Specificity | ESA Chagas Specificity | ESA Chagas Negative | 327 participants |
| ABBOTT PRISM Chagas Specificity | ESA Chagas Specificity | ESA Chagas Indeterminate | 3 participants |
95% CI: [97.4, 99.8]Percentage Negative
Primary
PRISM Chagas Sensitivity
Specimens from subjects known to be T cruzi parasite positive were tested with PRISM Chagas assay.
Time frame: 6 months
Population: Specimens from 110 individuals known to be positive for T cruzi parasite were tested with PRISM Chagas assay per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABBOTT PRISM Chagas Specificity | PRISM Chagas Sensitivity | PRISM Chagas Nonreactive | 0 participants |
| ABBOTT PRISM Chagas Specificity | PRISM Chagas Sensitivity | PRISM Chagas Reactive, Parasite Positive | 110 participants |
95% CI: [96.7, 100]Sensitivity
Primary
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
Population: All fresh blood donor specimens tested with PRISM Chagas assay during design validation phase per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABBOTT PRISM Chagas Specificity | PRISM Chagas Specificity | PRISM Chagas Reactive, RIPA Negative | 23 participants |
| ABBOTT PRISM Chagas Specificity | PRISM Chagas Specificity | PRISM Chagas Nonreactive | 16223 participants |
| ABBOTT PRISM Chagas Specificity | PRISM Chagas Specificity | PRISM Chagas Reactive, RIPA Positive | 3 participants |
95% CI: [99.79, 99.91]Point Estimate
Secondary
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
Population: A total of 85 serum specimens from non-US individuals reactive for T cruzi antibodies per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABBOTT PRISM Chagas Specificity | ESA Chagas Sensitivity in Serologically Positive Non-US Specimens | ESA Chagas Positve | 85 participants |
| ABBOTT PRISM Chagas Specificity | ESA Chagas Sensitivity in Serologically Positive Non-US Specimens | ESA Chagas Negative | 0 participants |
Secondary
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
Population: Total of 132 out of the 524 specimens from Chagas endemic areas that were tested RIPA positive per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABBOTT PRISM Chagas Specificity | ESA Chagas Testing in Chagas Endemic Population | ESA Chagas Postive, RIPA Positive | 130 participants |
| ABBOTT PRISM Chagas Specificity | ESA Chagas Testing in Chagas Endemic Population | ESA Chagas Indeterminate, RIPA Positive | 2 participants |
Secondary
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
Population: A total of 58 US blood donor specimens were PRISM Chagas repeatedly reactive were included per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABBOTT PRISM Chagas Specificity | ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas. | ESA Chagas Positive, RIPA Positive | 9 participants |
| ABBOTT PRISM Chagas Specificity | ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas. | ESA Chagas Positive, RIPA Negative | 49 participants |
Secondary
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
Population: Total of 524 specimens from Chagas endemic areas tested with PRISM Chagas per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABBOTT PRISM Chagas Specificity | PRISM Chagas Reactivity in Chagas Endemic Population | PRISM Chagas Reactive, RIPA Positive | 129 participants |
| ABBOTT PRISM Chagas Specificity | PRISM Chagas Reactivity in Chagas Endemic Population | PRISM Chagas Reactive, RIPA Negative | 5 participants |
| ABBOTT PRISM Chagas Specificity | PRISM Chagas Reactivity in Chagas Endemic Population | PRISM Chagas Reactive, RIPA Indeterminate | 3 participants |
| ABBOTT PRISM Chagas Specificity | PRISM Chagas Reactivity in Chagas Endemic Population | PRISM Chagas Nonreactive, RIPA Positive | 2 participants |
| ABBOTT PRISM Chagas Specificity | PRISM Chagas Reactivity in Chagas Endemic Population | PRISM Chagas Nonreactive, RIPA Negative | 385 participants |
| ABBOTT PRISM Chagas Specificity | PRISM Chagas Reactivity in Chagas Endemic Population | PRISM Chagas Nonreactive, RIPA Indeterminate | 0 participants |
Secondary
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
Population: Total of 287 specimens presumed T cruzi antibody positive per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABBOTT PRISM Chagas Specificity | PRISM Chagas Reactivity Serology Positive Specimens | PRISM Chagas Reactive, RIPA Positive | 224 participants |
| ABBOTT PRISM Chagas Specificity | PRISM Chagas Reactivity Serology Positive Specimens | PRISM Chagas Reactive, RIPA Negative | 24 participants |
| ABBOTT PRISM Chagas Specificity | PRISM Chagas Reactivity Serology Positive Specimens | PRISM Chagas Nonreactive, RIPA Negative | 39 participants |
| ABBOTT PRISM Chagas Specificity | PRISM Chagas Reactivity Serology Positive Specimens | PRISM Chagas Nonreactive, RIPA Positive | 0 participants |