Abbott ESA Chagas Assay Post-Market Study

• Sponsor: Abbott Diagnostics Division (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01662362
• Collaborator: (none)
• Enrollment: 63
• Locations: 2
• Arm: 1
• Duration (Months): 5
• Patients Per Site: 31.5
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief Summary

The study is conducted to meet an FDA post market commitment to collect and report data on the performance of the ESA Chagas assay. A minimum of 50 donor specimens that are FDA-licensed ABBOTT PRISM Chagas repeatedly reactive (RR)will be tested with the ABBOTT ESA Chagas assay. In addition, minimum of 300 ABBOTT PRISM Chagas nonreactive (NR) unidentified donor specimens will be tested with ABBOTT ESA Chagas assay.

Condition or Disease	Intervention/Treatment	Phase
Chagas Disease	Device: Testing Donor Specimens with ESA Chagas	N/A

Detailed Description

ABBOTT ESA Chagas testing will be performed at a minimum of two blood donor centers. Testing will be performed using the FDA-licensed ESA Chagas assay and will be performed in accordance with the ESA Chagas package insert. ABBOTT PRISM Chagas repeatedly reactive blood donor specimens identified by U.S. blood donor centers, as part of the routine blood donation process, will be tested with the FDA-licensed ESA Chagas. Specimens will also be tested with radioimmune precipitation assay (RIPA) for antibody to T. cruzi, a laboratory developed test, and the FDA-licensed ORTHO T. cruzi ELISA. The donor centers will contact the donors and request the donor to return to complete a questionnaire and provide a follow-up specimen.

In addition, a minimum of 300 blood donor specimens with ABBOTT PRISM Chagas nonreactive results will also be tested with ESA Chagas. These specimens will be unidentified, leftover specimens from routine donor testing and not individually identifiable. Specimens that are positive or indeterminate with ESA Chagas will be further tested with RIPA.

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Abbott ESA Chagas Assay Post-Market Study
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Testing Donor Specimens with ESA Chagas Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.	Device: Testing Donor Specimens with ESA Chagas; Donors will be asked to return for a follow-up blood draw.; Other Names: ABBOTT ESA Chagas (ESA Chagas) assay List Number: 8L34

Outcome Measures

Primary Outcome Measures

1. ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas [Up to six months]

Secondary Outcome Measures

1. ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas [Up to six months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

PRISM Chagas Repeatedly Reactive Donor Specimens

Inclusion Criteria:

• Blood donor specimen documented as PRISM Chagas repeatedly reactive

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LifeSource	Rosemont	Illinois	United States	60018
2	American Red Cross	Gaithersburg	Maryland	United States	20877

Sponsors and Collaborators

• Abbott Diagnostics Division

Investigators

• Principal Investigator: Susan Stramer, Ph.D., American National Red Cross
• Principal Investigator: Sharon Gordon, MS, MBA, MT, LifeSource

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Diagnostics Division
• ClinicalTrials.gov Identifier: NCT01662362
• Other Study ID Numbers: 7B5-02-10P02-01
• First Posted: Aug 10, 2012
• Last Update Posted: Feb 20, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Abbott Diagnostics Division: Chagas Disease; Trypanosoma cruzi; American trypanosomiasis; South American trypanosomiasis; kissing bugs; reduviid bugs
• Additional relevant MeSH terms: Chagas Disease

Study Results

Participant Flow

Arm/Group Title	Testing Donor Specimens With ESA Chagas
Arm/Group Description	Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw. Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw.
Period Title: Overall Study
STARTED	63
COMPLETED	25
NOT COMPLETED	38

Baseline Characteristics

Arm/Group Title	Testing Donor Specimens With ESA Chagas
Arm/Group Description	Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw. Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw.
Overall Participants	63
Age, Customized (participants) [Number]
>= 18 years	19 30.2%
Unknown	44 69.8%
Sex/Gender, Customized (participants) [Number]
Male	9 14.3%
Female	10 15.9%
Unknown	44 69.8%
Region of Enrollment (participants) [Number]
United States	63 100%

Outcome Measures

1. Primary Outcome

Title	ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas
Time Frame	Up to six months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Testing Donor Specimens With ESA Chagas
Arm/Group Description	Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw. Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw.
Measure Participants	63
Number (95% Confidence Interval) [percent agreement to RIPA]	92.06

2. Secondary Outcome

Title	ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas
Time Frame	Up to six months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Testing Donor Specimens With ESA Chagas
Arm/Group Description	Test blood donor specimens that are ABBOTT PRISM Chagas Nonreactive with ESA Chagas. These specimens will be unidentified specimens from routine donor testing and not individually identifiable. Specimens that are positive or indeterminate with ESA Chagas will be further tested with RIPA.
Measure Participants	300
Number (95% Confidence Interval) [percentage of specimens ESA negative]	99.00

Adverse Events

Arm/Group Title	Testing Donor Specimens With ESA Chagas
Arm/Group Description	Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw. Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw.
All Cause Mortality
	Testing Donor Specimens With ESA Chagas
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Testing Donor Specimens With ESA Chagas
	Affected / at Risk (%)	# Events
Total	0/63 (0%)
Other (Not Including Serious) Adverse Events
	Testing Donor Specimens With ESA Chagas
	Affected / at Risk (%)	# Events
Total	0/63 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.