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丙型肝炎病毒感染的实验室检测方法及策略
DOI: 10.12449/JCH240405
利益冲突声明：本文不存在任何利益冲突。
作者贡献声明：王宇负责查找文献，撰写文稿；金聪、邢文革负责撰写和审阅文稿；刘中夫负责审阅文稿及定稿。
Advances in laboratory testing methods and strategies for hepatitis C virus infection
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摘要: 丙型肝炎病毒（HCV）感染的实验室检测为HCV感染者的检测发现和诊断提供关键依据。近年来，HCV感染检测技术不断发展，检测试剂性能显著提高，新的检测服务策略不断出现并逐步推广应用。本文归纳了国内外HCV感染的实验室检测方法及检测策略，总结了HCV感染检测的方法，分析了新方法和新策略对我国HCV感染防控带来的影响。及时准确的实验室检测方法和有效可行的检测策略有助于HCV感染的早发现、早诊断、早治疗，最终实现2030年消除病毒性肝炎主要公共卫生危害的战略目标。Abstract: Laboratory testing for hepatitis C virus （HCV） infection provides an important basis for the identification and diagnosis of patients with HCV infection. With the continuous development of HCV testing in recent years， the performance of reagents has been significantly improved， and new testing service strategies have emerged and gradually been applied in clinical practice. This article summarizes the laboratory testing methods and strategies for HCV infection in China and globally， as well as the testing methods for HCV infection， and analyzes the influence of new methods and strategies on the prevention and control of HCV infection in China. Timely and accurate laboratory testing methods and effective and feasible testing strategies may help to realize the early identification， early diagnosis， and early treatment of HCV infection and ultimately achieve the strategic goal of eliminating viral hepatitis as a major public health threat by 2030.
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Key words:
- Hepacivirus /
- Biomarkers /
- Diagnosis
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图 1 外周血中HCV感染检测标志物的动态变化［5］
注： a，自限性HCV感染；b，慢性HCV感染。
Figure 1. Dynamic change of biomarkers for HCV testing in peripheral blood
表 1 获批的HCV感染检测方法和检测产品数量
Table 1. Approved HCV testing methods and products
检测方法 检测产品的数量 总计 国产产品 进口产品 ELISA 抗体 25 23 2 抗原 4 4 0 抗原抗体 2 2 0 CLIA 抗体 37 31 6 抗原 2 1 1 抗原抗体 1 1 0 快检（抗体） 29 29 0 WB（抗体） 1 0 1 RIBA（抗体） 2 1 1 核酸检测 RNA定性 4 1 3 RNA定量 31 25 6 RNA定性+定量 4 0 4 
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表 2 HCV筛查试剂的发展
Table 2. Development of HCV screening reagents
项目 第一代 第二代 第三代 第四代 靶点 NS4（c100-3） C，NS3，NS4 C，NS3，NS4 衣壳抗原，C，NS3，NS4 敏感度 <95% >95% >95% >99% 特异度 <95% >95% >95% >99% 窗口期 16～24周 7～8周 7～8周 4～8周
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