Trial Outcomes & Findings for Evaluation of Chagas Blood Screening and Confirmatory Assays (NCT NCT00718042)
NCT ID: NCT00718042
Last Updated: 2012-03-07
Results Overview
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 \[radioimmune precipitation assay (RIPA)\].
COMPLETED
NA
41862 participants
6 months
2012-03-07
Participant Flow
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.
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.
Participant milestones
| Measure |
ABBOTT PRISM Chagas Specificity
All blood donor specimens tested by the investigational Chagas screening test in design validation phase.
|
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.
|
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.
|
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.
|
Chagas Extended Evaluation
US blood donor specimen were tested with investigational Chagas screening assay to identify repeatedly reactive specimens.
|
ESA Chagas Specificity
US blood donor specimen presumed antibody negative for T cruzi antibody were tested with investigational ESA Chagas.
|
|---|---|---|---|---|---|---|
|
ABBOTT PRISM Chagas Testing
STARTED
|
16313
|
289
|
525
|
110
|
25549
|
0
|
|
ABBOTT PRISM Chagas Testing
COMPLETED
|
16249
|
287
|
524
|
110
|
25511
|
0
|
|
ABBOTT PRISM Chagas Testing
NOT COMPLETED
|
64
|
2
|
1
|
0
|
38
|
0
|
|
ESA Chagas Testing
STARTED
|
36
|
287
|
524
|
110
|
43
|
330
|
|
ESA Chagas Testing
COMPLETED
|
36
|
287
|
524
|
110
|
43
|
330
|
|
ESA Chagas Testing
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Donor Follow-up
STARTED
|
36
|
0
|
0
|
0
|
43
|
0
|
|
Donor Follow-up
COMPLETED
|
23
|
0
|
0
|
0
|
24
|
0
|
|
Donor Follow-up
NOT COMPLETED
|
13
|
0
|
0
|
0
|
19
|
0
|
Reasons for withdrawal
| Measure |
ABBOTT PRISM Chagas Specificity
All blood donor specimens tested by the investigational Chagas screening test in design validation phase.
|
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.
|
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.
|
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.
|
Chagas Extended Evaluation
US blood donor specimen were tested with investigational Chagas screening assay to identify repeatedly reactive specimens.
|
ESA Chagas Specificity
US blood donor specimen presumed antibody negative for T cruzi antibody were tested with investigational ESA Chagas.
|
|---|---|---|---|---|---|---|
|
ABBOTT PRISM Chagas Testing
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
0
|
|
ABBOTT PRISM Chagas Testing
Protocol Violation
|
64
|
0
|
0
|
0
|
36
|
0
|
|
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
|
|
Donor Follow-up
Lost to Follow-up
|
13
|
0
|
0
|
0
|
19
|
0
|
Baseline Characteristics
Evaluation of Chagas Blood Screening and Confirmatory Assays
Baseline characteristics by cohort
| Measure |
ABBOTT PRISM Chagas Specificity
n=16313 Participants
All subject's blood tested by the investigational Chagas screening test.
|
Reactivity T Cruzi Antibody Positive
n=289 Participants
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.
|
Reactivity in Chagas Endemic Population
n=525 Participants
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.
|
ESA Chagas Specificity
n=330 Participants
US blood donor specimen presumed antibody negative for T cruzi antibody were tested with investigational ESA Chagas.
|
Sensitivity Chagas Parasitology Positive Specimens
n=110 Participants
Specimen collected in South/Central America under separate specimen collection protocols were tested with investigational Chagas screening assay and with ESA Chagas.
|
Chagas Extended Evaluation
n=25549 Participants
All subject's blood tested by the investigational Chagas screening test.
|
Total
n=43116 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
>= 18 years
|
16313 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
525 Participants
n=206 Participants
|
330 Participants
n=7 Participants
|
110 Participants
n=31 Participants
|
25549 Participants
n=30 Participants
|
42912 Participants
n=3 Participants
|
|
Age, Customized
Not Collected
|
0 Participants
n=99 Participants
|
204 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
204 Participants
n=3 Participants
|
|
Sex/Gender, Customized
Female
|
0 Participant
n=99 Participants
|
44 Participant
n=107 Participants
|
336 Participant
n=206 Participants
|
0 Participant
n=7 Participants
|
53 Participant
n=31 Participants
|
0 Participant
n=30 Participants
|
433 Participant
n=3 Participants
|
|
Sex/Gender, Customized
Male
|
0 Participant
n=99 Participants
|
41 Participant
n=107 Participants
|
189 Participant
n=206 Participants
|
0 Participant
n=7 Participants
|
57 Participant
n=31 Participants
|
0 Participant
n=30 Participants
|
287 Participant
n=3 Participants
|
|
Sex/Gender, Customized
Not Collected
|
16313 Participant
n=99 Participants
|
204 Participant
n=107 Participants
|
0 Participant
n=206 Participants
|
330 Participant
n=7 Participants
|
0 Participant
n=31 Participants
|
25549 Participant
n=30 Participants
|
42396 Participant
n=3 Participants
|
|
Region of Enrollment
United States
|
16313 participants
n=99 Participants
|
204 participants
n=107 Participants
|
0 participants
n=206 Participants
|
330 participants
n=7 Participants
|
0 participants
n=31 Participants
|
25549 participants
n=30 Participants
|
42396 participants
n=3 Participants
|
|
Region of Enrollment
Argentina
|
0 participants
n=99 Participants
|
85 participants
n=107 Participants
|
176 participants
n=206 Participants
|
0 participants
n=7 Participants
|
76 participants
n=31 Participants
|
0 participants
n=30 Participants
|
337 participants
n=3 Participants
|
|
Region of Enrollment
Brazil
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
50 participants
n=206 Participants
|
0 participants
n=7 Participants
|
7 participants
n=31 Participants
|
0 participants
n=30 Participants
|
57 participants
n=3 Participants
|
|
Region of Enrollment
Guatemala
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
149 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
149 participants
n=3 Participants
|
|
Region of Enrollment
Panama
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
50 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
50 participants
n=3 Participants
|
|
Region of Enrollment
Peru
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
100 participants
n=206 Participants
|
0 participants
n=7 Participants
|
5 participants
n=31 Participants
|
0 participants
n=30 Participants
|
105 participants
n=3 Participants
|
|
Region of Enrollment
Bolivia
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
22 participants
n=31 Participants
|
0 participants
n=30 Participants
|
22 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All fresh blood donor specimens tested with PRISM Chagas assay during design validation phase per protocol.
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 \[radioimmune precipitation assay (RIPA)\].
Outcome measures
| Measure |
ABBOTT PRISM Chagas Specificity
n=16249 Participants
Specificity will be determined for the blood donor specimens tested with the investigational PRISM Chagas screening test.
|
|---|---|
|
PRISM Chagas Specificity
PRISM Chagas Reactive, RIPA Negative
|
23 participants
|
|
PRISM Chagas Specificity
PRISM Chagas Nonreactive
|
16223 participants
|
|
PRISM Chagas Specificity
PRISM Chagas Reactive, RIPA Positive
|
3 participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Specimens from 110 individuals known to be positive for T cruzi parasite were tested with PRISM Chagas assay per protocol.
Specimens from subjects known to be T cruzi parasite positive were tested with PRISM Chagas assay.
Outcome measures
| Measure |
ABBOTT PRISM Chagas Specificity
n=110 Participants
Specificity will be determined for the blood donor specimens tested with the investigational PRISM Chagas screening test.
|
|---|---|
|
PRISM Chagas Sensitivity
PRISM Chagas Reactive, Parasite Positive
|
110 participants
|
|
PRISM Chagas Sensitivity
PRISM Chagas Nonreactive
|
0 participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Determine percentage of donor specimens ESA Chagas negative in a presumed negative population per protocol.
Preselected US blood donor specimens (330) presumed T cruzi antibody negative negative that were tested only with the investigational ESA Chagas.
Outcome measures
| Measure |
ABBOTT PRISM Chagas Specificity
n=330 Participants
Specificity will be determined for the blood donor specimens tested with the investigational PRISM Chagas screening test.
|
|---|---|
|
ESA Chagas Specificity
ESA Chagas Negative
|
327 participants
|
|
ESA Chagas Specificity
ESA Chagas Indeterminate
|
3 participants
|
|
ESA Chagas Specificity
ESA Chagas Positive
|
0 participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Specimens from 110 subjects known to be positive for T cruzi parasite tested with ESA Chagas per protocol.
Specimens from individuals known to be T cruzi parasite positive were tested with ESA Chagas assay.
Outcome measures
| Measure |
ABBOTT PRISM Chagas Specificity
n=110 Participants
Specificity will be determined for the blood donor specimens tested with the investigational PRISM Chagas screening test.
|
|---|---|
|
ESA Chagas Sensitivity
ESA Chagas Positive
|
110 participants
|
|
ESA Chagas Sensitivity
ESA Chagas Negative
|
0 participants
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Total of 287 specimens presumed T cruzi antibody positive per protocol.
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).
Outcome measures
| Measure |
ABBOTT PRISM Chagas Specificity
n=287 Participants
Specificity will be determined for the blood donor specimens tested with the investigational PRISM Chagas screening test.
|
|---|---|
|
PRISM Chagas Reactivity Serology Positive Specimens
PRISM Chagas Reactive, RIPA Positive
|
224 participants
|
|
PRISM Chagas Reactivity Serology Positive Specimens
PRISM Chagas Reactive, RIPA Negative
|
24 participants
|
|
PRISM Chagas Reactivity Serology Positive Specimens
PRISM Chagas Nonreactive, RIPA Negative
|
39 participants
|
|
PRISM Chagas Reactivity Serology Positive Specimens
PRISM Chagas Nonreactive, RIPA Positive
|
0 participants
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Total of 524 specimens from Chagas endemic areas tested with PRISM Chagas per protocol.
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.
Outcome measures
| Measure |
ABBOTT PRISM Chagas Specificity
n=524 Participants
Specificity will be determined for the blood donor specimens tested with the investigational PRISM Chagas screening test.
|
|---|---|
|
PRISM Chagas Reactivity in Chagas Endemic Population
PRISM Chagas Reactive, RIPA Positive
|
129 participants
|
|
PRISM Chagas Reactivity in Chagas Endemic Population
PRISM Chagas Reactive, RIPA Negative
|
5 participants
|
|
PRISM Chagas Reactivity in Chagas Endemic Population
PRISM Chagas Reactive, RIPA Indeterminate
|
3 participants
|
|
PRISM Chagas Reactivity in Chagas Endemic Population
PRISM Chagas Nonreactive, RIPA Positive
|
2 participants
|
|
PRISM Chagas Reactivity in Chagas Endemic Population
PRISM Chagas Nonreactive, RIPA Negative
|
385 participants
|
|
PRISM Chagas Reactivity in Chagas Endemic Population
PRISM Chagas Nonreactive, RIPA Indeterminate
|
0 participants
|
SECONDARY outcome
Timeframe: 15 monthsPopulation: A total of 58 US blood donor specimens were PRISM Chagas repeatedly reactive were included per protocol.
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.
Outcome measures
| Measure |
ABBOTT PRISM Chagas Specificity
n=58 Participants
Specificity will be determined for the blood donor specimens tested with the investigational PRISM Chagas screening test.
|
|---|---|
|
ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas.
ESA Chagas Positive, RIPA Negative
|
49 participants
|
|
ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas.
ESA Chagas Positive, RIPA Positive
|
9 participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: A total of 85 serum specimens from non-US individuals reactive for T cruzi antibodies per protocol.
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.
Outcome measures
| Measure |
ABBOTT PRISM Chagas Specificity
n=85 Participants
Specificity will be determined for the blood donor specimens tested with the investigational PRISM Chagas screening test.
|
|---|---|
|
ESA Chagas Sensitivity in Serologically Positive Non-US Specimens
ESA Chagas Positve
|
85 participants
|
|
ESA Chagas Sensitivity in Serologically Positive Non-US Specimens
ESA Chagas Negative
|
0 participants
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Total of 132 out of the 524 specimens from Chagas endemic areas that were tested RIPA positive per protocol.
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.
Outcome measures
| Measure |
ABBOTT PRISM Chagas Specificity
n=132 Participants
Specificity will be determined for the blood donor specimens tested with the investigational PRISM Chagas screening test.
|
|---|---|
|
ESA Chagas Testing in Chagas Endemic Population
ESA Chagas Postive, RIPA Positive
|
130 participants
|
|
ESA Chagas Testing in Chagas Endemic Population
ESA Chagas Indeterminate, RIPA Positive
|
2 participants
|
Adverse Events
Donor Follow-up Specimen Collection
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER