A Registration Study to Evaluate the Performance of CHIRON® RIBA® HCV 3.0 SIA in HCV Antibody Detection
Last updated on July 2021Recruitment
- Recruitment Status
- Terminated
- Estimated Enrollment
- 1000
Summary
- Conditions
- Hepatitis C
- Type
- Observational
- Design
- Observational Model: Case-OnlyTime Perspective: Prospective
Participation Requirements
- Age
- Between 1 years and 90 years
- Gender
- Both males and females
Description
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 a...
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.
Tracking Information
- NCT #
- NCT01582594
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Yuanli Mao, Professor Beijing 302 Hospital Principal Investigator: Yanping Luo, Professor Chinese PLA General Hospital Principal Investigator: Xinxin Zhang, Professor Ruijin Hospital Principal Investigator: Tai Guo, Director National Institites of Food and Drug control
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