At a glance
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Alinity s Anti-HCV II - Clinical Evaluation Protocol
In Brief
A clinical study evaluating Alinity s Anti-HCV II for Healthy. Completed, enrolled 16,388 participants across 4 sites.
Detailed Summary
The objective of this study is to demonstrate the performance and intended use of the Alinity s Anti-HCV II investigational assay in a donor screening environment using clinical samples to evaluate assay performance. The Alinity s Anti-HCV II assay performance will be evaluated utilizing the Food and Drug Administration (FDA) licensed Alinity s Anti-HCV assay as the comparator method. The data will be used to support regulatory submissions and/or publications.
Study Details
Timeline
Interventions
For all donor specimens with investigational Alinity s Anti-HCV II results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.