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迄今,由丙型肝炎病毒(HCV)引起的丙型肝炎仍是非甲非乙型肝炎的主要病原,其传染性强,易于慢性化,对人类危害甚大。目前丙型肝炎的诊断主要依赖于抗HCV及HCVRNA的检测。虽已有不少商品化试剂盒提供于临床应用,如何规范检测试剂,使之更有效地诊断、监测HCV感染,仍是广大微生物学工作者、临床工作者关心的课题。为此,美国FDA最近在网上公布了《HCV感染检测方法审批草案》(Premarket Approval Applications for Assays Pertaning to Hepatitis C
To date, hepatitis C virus caused by hepatitis C virus (HCV) is still the major causative agent of non-A, non-B hepatitis. It is highly contagious and easy to be chronic, which is harmful to human beings. The current diagnosis of hepatitis C mainly depends on the detection of anti-HCV and HCVRNA. Although many commercial kits have been provided for clinical application, how to standardize the testing reagents and make them more effective in diagnosing and monitoring HCV infection remains a topic of concern to the majority of microbiologists and clinicians. To this end, the United States FDA recently published on the Internet “HCV infection testing methods approval draft” (Premarket Approval Applications for Assays Pertaning to Hepatitis C