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丙型肝炎病毒感染的实验室检测方法及策略

王宇 邢文革 刘中夫 金聪

引用本文:
Citation:

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。
详细信息
    通信作者:

    金聪, jinc@chinaaids.cn (ORCID: 0000-0002-2344-6561)

Advances in laboratory testing methods and strategies for hepatitis C virus infection

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    Corresponding author: JIN Cong, jinc@chinaaids.cn (ORCID: 0000-0002-2344-6561)
  • 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。

     

  • 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

    图  2  HCV常规检测流程5

    注:*对过去6个月内可能有HCV暴露的个体,建议行HCV RNA检测或后续随访检测HCV抗体。对于免疫功能缺陷的个体,可以考虑行HCV RNA检测。**若怀疑抗体检测假阳性,可使用另一种HCV抗体检测方法检测。*** HCV RNA检测可使用基于实验室的核酸检测,也可使用即时核酸检测。当无法行HCV RNA检测时,也可使用HCV抗原检测。****对过去6个月内可能有HCV暴露的个体,或者有HCV感染的临床证据,或者担心样本质量有问题,可以重复HCV RNA检测或追踪观察。

    Figure  2.  Routine HCV testing algorithm5

    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
    下载: 导出CSV

    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
    下载: 导出CSV
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