Healthy Clinical Trial
Official title:
Alinity s Anti-HCV II - Clinical Evaluation Protocol
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.
This study evaluates the Alinity s Anti-HCV II investigational assay using the Alinity s System. The Alinity s Anti-HCV II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma specimens on the Alinity s System. The Alinity s Anti-HCV II assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HCV. The performance of the Alinity s Anti-HCV II assay will be evaluated by performing specificity, and sensitivity testing of the Alinity s Anti-HCV II assay. To evaluate specificity, approximately 15,000 random unique donor specimens will be collected. To evaluate sensitivity, Abbott will provide a minimum of 400 frozen samples from U.S. individuals characterized as HCV positive and a minimum of 400 frozen specimens from U.S. individuals at increased risk for HCV infection. ;
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