A Registration Study to Evaluate the Performance of CHIRON® RIBA® HCV 3.0 SIA in HCV Antibody Detection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 795
- 试验地点
- 4
- 主要终点
- To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Residual serum or plasma specimens after routine clinical testing; fresh specimens or frozen specimens stored at -20°C or lower within 2 years after collection, with sufficient volume (≥0.5 mL) to complete all the study tests ; 2) Residual serum or plasma specimen is acceptable; matched serum and plasma with EDTA, heparin or citrate used as the anticoagulant. The collection and preparation of the specimens should comply with the standard laboratory operation procedures and the instruction for use (IFU).
排除标准
- •Severely hemolytic or turbid specimens; 2) Bacterial contaminated specimens; 3) Specimens that are improperly collected, prepared, or stored or not in accordance with package insert instructions.
- •Elimination criteria:
- •Errors arising during testing in which the specimen cannot be repeated shall be excluded;
- •Test results that do not pass routine quality control will not be used
- •Any specimen in which the case report form has incomplete data, or the case report form is missing the principal investigator's signature will not be used in the study. Case report forms with missing data will have an explanation for the missing data and should be signed by the principal investigator.
- •Use of unqualified reagents for specimen testing.
结局指标
主要结局
To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0
时间窗: up to 30 weeks
To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0 (RIBA, Investigational Product) test using known anti-HCV seropositive and seronegative specimens. As the study early terminated,no evaluation performed.
次要结局
- the effect and applicability of different sample types on RIBA test results(up to 30 weeks)
- potential interference in RIBA(up to 30 weeks)