Hepatitis C Clinical Trial
Official title:
A Registration Study to Evaluate the Performance of CHIRON® RIBA® HCV 3.0 SIA in HCV Antibody Detection
To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0 (RIBA, Investigational Product) test
using known anti-HCV seropositive and seronegative specimens.
Registration for license application
To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0 (RIBA, Investigational Product) test
using known anti-HCV seropositive and seronegative specimens.
To evaluate the effect and applicability of different sample types on RIBA test results
through the tests of the investigational product on serum and plasma collected from the same
donors.
The specimens with HAV IgG positive, or HBsAg positive, or HEV IgG positive, or anti-HIV
positive will be collected and tested for potential interference in the investigational
product when used for testing the specimens infected by viruses other than HCV.
This clinical trial is for registration purpose, the study data will be submitted to
Regulatory Authority (SFDA) for license application for CHIRON®RIBA®HCV 3.0 SIA reagent.
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Observational Model: Case-Only, Time Perspective: Prospective
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