Clinical trial NCT00718042: Evaluation of Chagas Blood Screening and Confirmatory Assays
Official title: Evaluation of ABBOTT PRISM Chagas Assay and Chagas Confirmatory Assay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: healthy donors
Lead sponsor: Abbott Diagnostics Division
Sponsor class: INDUSTRY
First posted: 2008-07-18
Enrollment: 41862
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility criteria: Inclusion Criteria:

* Healthy donors that have consented to participate in study

Exclusion Criteria:

* N/A

Primary outcomes:
measure: PRISM Chagas Specificity
timeFrame: 6 months
measure: PRISM Chagas Sensitivity
timeFrame: 6 months
measure: ESA Chagas Specificity
timeFrame: 3 months
measure: ESA Chagas Sensitivity
timeFrame: 3 months
Secondary outcomes:
measure: PRISM Chagas Reactivity Serology Positive Specimens
timeFrame: 4 months
measure: PRISM Chagas Reactivity in Chagas Endemic Population
timeFrame: 2 months
measure: ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas.
timeFrame: 15 months
measure: ESA Chagas Sensitivity in Serologically Positive Non-US Specimens
timeFrame: 3 months
measure: ESA Chagas Testing in Chagas Endemic Population
timeFrame: 2 months
Other outcomes:
Locations:
city: Lakeland
country: United States
facility: BloodNet USA
state: Florida
city: St. Petersburg
country: United States
facility: Florida Blood Services
state: Florida
city: Glenview
country: United States
facility: LifeSource Blood Center
state: Illinois
city: Charlotte
country: United States
facility: American Red Cross Charlotte NTL
state: North Carolina
city: Portland
country: United States
facility: American Red Cross
state: Oregon
city: Providence
country: United States
facility: Rhode Island Blood Center
state: Rhode Island
city: San Antonio
country: United States
facility: South Texas Blood and Tissue Center
state: Texas
Study officials:
affiliation: American National Red Cross
name: Susan Stramer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lifesource
name: Sharon Gordon
role: PRINCIPAL_INVESTIGATOR
affiliation: South Texas Blood and Tissue Center
name: Norman Kalmin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rhode Island Blood Center
name: Carolyn T Young, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida Blood Services
name: Deborah Williams
role: PRINCIPAL_INVESTIGATOR
affiliation: Blood Net USA
name: Pauline Simmonds-Brown
role: PRINCIPAL_INVESTIGATOR
References: