PoC-HCV Genedrive Viral Detection Assay Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 417
- 主要终点
- Accuracy of HCV RNA detection with PoC assay (Genedrive, Epistem) vs reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott).
研究概览
简要总结
The principal objective is to assess the diagnostic accuracy of the PoC assay (Genedrive, Epistem) to detect HCV RNA against the reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott) using stored heparinized plasma from patients with chronic hepatitis C and non-infected controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Criteria for case
- •Age > 18 years old.
- •Patients with positive HCV RNA.
- •Heparinized plasma samples are available before the initiation of antiviral HCV therapy.
- •Patients have given a written consent that their blood samples will be further used for research.
- •Criteria for control
- •Age > 18 years old.
- •Participants were tested negative for anti-HCV antibody
- •Heparinized plasma samples are available
- •Participants have given a written consent that their blood samples will be further used for research
排除标准
- 未提供
结局指标
主要结局
Accuracy of HCV RNA detection with PoC assay (Genedrive, Epistem) vs reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott).
时间窗: pre-treatment
Assess the diagnostic accuracy of the PoC assay (Genedrive, Epistem) to detect HCV RNA against the reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott) using stored heparinized plasma from patients with chronic hepatitis C and non-infected controls (with Genedrive channel acceptance set at 2 out of 3).
次要结局
- Assess the inter-examiner reproducibility of the PoC assay.(Pre-treatment)
- Diagnostic algorithm optimization(Pre-treatment)
- Factors associated with false-positive of false-negative results(Pre-treatment)