HealthyNCT00718042

Evaluation of Chagas Blood Screening and Confirmatory Assays

A study testing ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay in people with Healthy, run by Abbott Diagnostics Division at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41,862 participants
Where: 7 sitesUnited States
Study dates: Jun 2008to Sep 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy donors that have consented to participate in study

Who cannot join

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

American Red Cross Charlotte NTL
Charlotte, North Carolina, 28273
LifeSource Blood Center
Glenview, Illinois, 60025
BloodNet USA
Lakeland, Florida, 33805
American Red Cross
Portland, Oregon, 97220
Rhode Island Blood Center
Providence, Rhode Island, 02908
South Texas Blood and Tissue Center
San Antonio, Texas, 78201
Florida Blood Services
St. Petersburg, Florida, 33716

Other trials in United States

About this study

Official title: Evaluation of ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay

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.

Conditions: Healthy
Being tested: ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay
Keywords: healthy donors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABBOTT PRISM Chagas Assay and Chagas Confirmatory AssayDevice
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.
ABBOTT PRISM Chagas Assay and Chagas Confirmatory AssayDevice
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.

Study groups in NCT00718042
Study group	Role	What they receive
1	Experimental	All subjects will have their blood tested by the investigational Chagas screening assay. Receives: Device: ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay
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. Receives: Device: ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay

What is being measured

The primary outcome is the main question the study is designed to answer.

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)].
Measured: 6 months
PRISM Chagas Sensitivity
Specimens from subjects known to be T cruzi parasite positive were tested with PRISM Chagas assay.
Measured: 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.
Measured: 3 months
ESA Chagas Sensitivity
Specimens from individuals known to be T cruzi parasite positive were tested with ESA Chagas assay.
Measured: 3 months

Secondary outcomes (5)

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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2008Sep 2009

First posted18 Jul 2008 (estimated)
Study startJun 2008
Primary completionJul 2009
Study completionSep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 41,862 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00718042
Sponsor's protocol ID: 7B5-02-06P06
Status last verified: Feb 2012
First submitted: 16 Jul 2008
Last updated: 7 Mar 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay
ClinicalTrials.gov ID: NCT00718042
Acronym / sponsor ID: 7B5-02-06P06
Conditions: Healthy
Keywords: healthy donors
Study type: Interventional
Recruitment status: Completed
Enrolment: 41,862 participants (actual)
Lead sponsor: Abbott Diagnostics DivisionIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Jul 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 18 Jul 2008 (estimated)
Results: Posted 23 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Device: ABBOTT PRISM Chagas Assay and Chagas Confirmatory AssayAll subjects will have their blood tested by the investigational Chagas screening assay.
2	Experimental	Device: ABBOTT PRISM Chagas Assay and Chagas Confirmatory AssayTesting of blood donor samples with the investigational Chagas screening assay. Samples that test positive will be also tested with the Chagas confirmatory assay.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Healthy donors that have consented to participate in study

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ABBOTT PRISM Chagas Assay and Chagas Confirmatory AssayTest 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.	Device	1
ABBOTT PRISM Chagas Assay and Chagas Confirmatory AssayTest 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.	Device	2

Primary outcome

PRISM Chagas Specificity
Time frame: 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
Time frame: 6 months
Specimens from subjects known to be T cruzi parasite positive were tested with PRISM Chagas assay.
ESA Chagas Specificity
Time frame: 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
Time frame: 3 months
Specimens from individuals known to be T cruzi parasite positive were tested with ESA Chagas assay.

5 secondary outcomes

PRISM Chagas Reactivity Serology Positive Specimens
Time frame: 4 months
PRISM Chagas Reactivity in Chagas Endemic Population
Time frame: 2 months
ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas.
Time frame: 15 months
ESA Chagas Sensitivity in Serologically Positive Non-US Specimens
Time frame: 3 months
ESA Chagas Testing in Chagas Endemic Population
Time frame: 2 months

Results and safety

Results posted to the registry on 23 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ABBOTT PRISM Chagas Specificity	16,313	16,249
Reactivity T Cruzi Antibody Positive	289	287
Reactivity in Chagas Endemic Population	525	524
Sensitivity Chagas Parasitology Positive Specimens	110	110
Chagas Extended Evaluation	25,549	25,511
ESA Chagas Specificity	0	0

Primary outcome: PRISM Chagas Specificity

Time frame: 6 months. Number. Unit: participants

Measure	ABBOTT PRISM Chagas Specificity n = 16249
PRISM Chagas Reactive, RIPA Negative	23
PRISM Chagas Nonreactive	16223
PRISM Chagas Reactive, RIPA Positive	3

ABBOTT PRISM Chagas Specificity: Specificity: 99.86 (95% CI 99.79 to 99.91), Point Estimate

Population analysed: All fresh blood donor specimens tested with PRISM Chagas assay during design validation phase per protocol.

Primary outcome: PRISM Chagas Sensitivity

Time frame: 6 months. Number. Unit: participants

Measure	Sensitivity Chagas Parasitology Positive Specimens n = 110
PRISM Chagas Nonreactive	0
PRISM Chagas Reactive, Parasite Positive	110

Sensitivity Chagas Parasitology Positive Specimens: Point estimate: 100 (95% CI 96.70 to 100.00), Sensitivity

Population analysed: Specimens from 110 individuals known to be positive for T cruzi parasite were tested with PRISM Chagas assay per protocol.

Primary outcome: ESA Chagas Specificity

Time frame: 3 months. Number. Unit: participants

Measure	ESA Chagas Specificity n = 330
ESA Chagas Negative	327
ESA Chagas Indeterminate	3
ESA Chagas Positive	0

ESA Chagas Specificity: Percentage: 99.1 (95% CI 97.4 to 99.8), Percentage Negative

Population analysed: Determine percentage of donor specimens ESA Chagas negative in a presumed negative population per protocol.

Primary outcome: ESA Chagas Sensitivity

Time frame: 3 months. Number. Unit: participants

Measure	Sensitivity Chagas Parasitology Positive Specimens n = 110
ESA Chagas Positive	110
ESA Chagas Negative	0

Population analysed: Specimens from 110 subjects known to be positive for T cruzi parasite tested with ESA Chagas per protocol.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Donor Follow-up Specimen Collection	0 of 47 (0%)	0 of 47 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Susan Stramer, PhD principal investigator

American National Red Cross

Sharon Gordon principal investigator

Lifesource

Norman Kalmin, MD principal investigator

South Texas Blood and Tissue Center

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay in people with Healthy, run by Abbott Diagnostics Division at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PRISM Chagas Specificity (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00718042.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2012.