Status:
COMPLETED
Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol
Lead Sponsor:
Abbott Diagnostics Division
Conditions:
Healthy
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
The objective of this study is to demonstrate the performance and intended use of each of the Alinity s investigational assays in a donor screening environment using clinical specimens to evaluate ass...
Detailed Description
This study evaluates Alinity s investigational assays using the Alinity s System. The Alinity s System is a high-volume, automated, blood-screening analyzer that is designed to determine the presence ...
Eligibility Criteria
Inclusion
- Healthy donors who consented to participate in the study.
Exclusion
- For testing with the Alinity s Chagas assay, exclude donors that have been screened on a previous donation using a licensed test for antibodies to T cruzi.
- Note: A subject may participate at different times during the study for separate assay studies, but each subject should be represented only once for each assay.
- The protocol does not define an age limit. A donor must be at least 17 years old to donate to the general blood supply, or 16 years old with parental/guardian consent, if allowed by state law.
Key Trial Info
Start Date :
September 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2018
Estimated Enrollment :
106881 Patients enrolled
Trial Details
Trial ID
NCT03285295
Start Date
September 15 2017
End Date
June 21 2018
Last Update
October 9 2019
Active Locations (5)
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1
Biotest Pharmaceuticals Corporation
Boca Raton, Florida, United States, 33431
2
American Red Cross National Testing Laboratory
St Louis, Missouri, United States, 63108
3
CSL Plasma Inc.
Knoxville, Tennessee, United States, 37932
4
QualTex Laboratories
San Antonio, Texas, United States, 78201