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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | All subjects will have their blood tested by the investigational Chagas screening assay. |
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| 2 | Experimental | Testing of blood donor samples with the investigational Chagas screening assay. Samples that test positive will be also tested with the Chagas confirmatory assay. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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)]. | 6 months |
| PRISM Chagas Sensitivity | Specimens from subjects known to be T cruzi parasite positive were tested with PRISM Chagas assay. | 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. | 3 months |
| ESA Chagas Sensitivity | Specimens from individuals known to be T cruzi parasite positive were tested with ESA Chagas assay. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Stramer, PhD | American National Red Cross | Principal Investigator |
| Sharon Gordon | Lifesource | Principal Investigator |
| Norman Kalmin, MD | South Texas Blood and Tissue Center | Principal Investigator |
| Carolyn T Young, MD | Rhode Island Blood Center | Principal Investigator |
| Deborah Williams | Florida Blood Services | Principal Investigator |
| Pauline Simmonds-Brown | Blood Net USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BloodNet USA | Lakeland | Florida | 33805 | United States | ||
| Florida Blood Services |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | ABBOTT PRISM Chagas Specificity | All blood donor specimens tested by the investigational Chagas screening test in design validation phase. |
| FG001 | Reactivity T Cruzi Antibody Positive |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| ABBOTT PRISM Chagas Testing |
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| ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay | Device | 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. |
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| 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. |
| 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. | 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. | 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. | 2 months |
| St. Petersburg |
| Florida |
| 33716 |
| United States |
| LifeSource Blood Center | Glenview | Illinois | 60025 | United States |
| American Red Cross Charlotte NTL | Charlotte | North Carolina | 28273 | United States |
| American Red Cross | Portland | Oregon | 97220 | United States |
| Rhode Island Blood Center | Providence | Rhode Island | 02908 | United States |
| South Texas Blood and Tissue Center | San Antonio | Texas | 78201 | United States |
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.
| FG002 | 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. |
| FG003 | 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. |
| FG004 | Chagas Extended Evaluation | US blood donor specimen were tested with investigational Chagas screening assay to identify repeatedly reactive specimens. |
| FG005 | ESA Chagas Specificity | US blood donor specimen presumed antibody negative for T cruzi antibody were tested with investigational ESA Chagas. |
| COMPLETED |
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| NOT COMPLETED |
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| ESA Chagas Testing |
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| Donor Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | ABBOTT PRISM Chagas Specificity | All subject's blood tested by the investigational Chagas screening test. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | ESA Chagas Specificity | US blood donor specimen presumed antibody negative for T cruzi antibody were tested with investigational ESA Chagas. |
| BG004 | 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. |
| BG005 | Chagas Extended Evaluation | All subject's blood tested by the investigational Chagas screening test. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age was not collected for this study. | Number | Participants |
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| Sex/Gender, Customized | Gender was not collected for all study populations. | Number | Participant |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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)]. | All fresh blood donor specimens tested with PRISM Chagas assay during design validation phase per protocol. | Posted | Number | participants | 6 months |
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| 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). | Total of 287 specimens presumed T cruzi antibody positive per protocol. | Posted | Number | participants | 4 months |
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| Primary | PRISM Chagas Sensitivity | Specimens from subjects known to be T cruzi parasite positive were tested with PRISM Chagas assay. | Specimens from 110 individuals known to be positive for T cruzi parasite were tested with PRISM Chagas assay per protocol. | Posted | Number | participants | 6 months |
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| 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. | Total of 524 specimens from Chagas endemic areas tested with PRISM Chagas per protocol. | Posted | Number | participants | 2 months |
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| 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. | A total of 58 US blood donor specimens were PRISM Chagas repeatedly reactive were included per protocol. | Posted | Number | participants | 15 months |
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| 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. | Determine percentage of donor specimens ESA Chagas negative in a presumed negative population per protocol. | Posted | Number | participants | 3 months |
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| Primary | ESA Chagas Sensitivity | Specimens from individuals known to be T cruzi parasite positive were tested with ESA Chagas assay. | Specimens from 110 subjects known to be positive for T cruzi parasite tested with ESA Chagas per protocol. | Posted | Number | participants | 3 months |
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| 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. | A total of 85 serum specimens from non-US individuals reactive for T cruzi antibodies per protocol. | Posted | Number | participants | 3 months |
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| 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. | Total of 132 out of the 524 specimens from Chagas endemic areas that were tested RIPA positive per protocol. | Posted | Number | participants | 2 months |
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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.
Adverse events were not applicable for blood donor specimens tested that were collected as part of routine blood donation and specimens provided by Abbott to testing sites.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Donor Follow-up Specimen Collection | Blood donors | 0 | 47 | 0 | 47 |
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The PI must provide a copy of any proposed publication/presentation at least 30 days prior to submission for sponsor's review/approval. The PI must incorporate changes as the sponsor requires in order to protect the sponsor's proprietary rights and interests. The sponsor may require the PI to include acknowledgement of the sponsor's role in the study. The PI may be requested to delay publication/presentation an extra 60 days to enable sponsor to secure patent or other proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director Clincal Affairs | Abbott Laboratories | 847-937-8702 | barbara.kaesdorf@abbott.com |
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| Male |
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| Not Collected |
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| Argentina |
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| Brazil |
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| Guatemala |
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| Panama |
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| Peru |
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| Bolivia |
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| Title | Denominators | Categories | ||||
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| ESA Chagas Negative |
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| ESA Chagas Indeterminate |
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| ESA Chagas Positive |
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| Title | Denominators | Categories | ||||
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| ESA Chagas Positive |
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| ESA Chagas Negative |
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