丙型肝炎病毒实验室诊断的现状与存在的问题

实验室诊断方法对丙型肝炎病毒(HCV)感染的确认和治疗的监测起着关键作用.自从1989年HCV被鉴定至今的近20年间,随着分子生物学检测技术的发展,HCV的实验室诊断也取得了长足进步,但同时也有很多问题需要研究和解决.HCV抗体检测操作简便,耗时少,但对处于窗口期的标本容易漏检,且不能判别是活动性感染还是感染已被清除.HCV RNA检测有较高的敏感度和特异度,定量检测还可以用于抗病毒治疗监测;国际上,RNA检测的发展趋势为全自动化.目前RNA检测亟待解决的两个问题是标准化和高成本问题.近5年HCV抗原检测和抗原抗体联合检测试剂盒也已问世,但其敏感度尚不及RNA的检测.HCV基因分型主要基于核酸杂交或直接测序原理,均有相应的商品化试剂盒,但高成本限制了其在临床实验室的广泛应用.

Progress and challenges in the laboratory diagnosis of hepatitis C virus

Hepatitis C virus (HCV) is a common blood-borne pathogen that relies heavily on laboratory assays for the confirmation of infection. Anti-HCV testing is the earliest and classical method which is easy to perform but has a long window period (7 - 8 weeks with the third-generation method) compared to the nucleic acid test (NAT). NAT provides direct evidence for the presence of HCV and quantitative HCV RNA testing has been applied to monitor the antiviral response to treatment. In some developed countries NAT is also used for blood screening. Cost-effectiveness and standardization are the major challenges for NAT. In recent years HCV core antigen assay and the combination antigen-antibody assay have been introduced in some clinical laboratories and proved to be premising in the early diagnosis of HCV, whereas they still remain less sensitive than NAT and require methodological improvement. Finally, HCV genotyping assays based on sequencing or reverse hybridization can provide important prognostic information related to therapeutic response, however, it is rarely used in China due to the high cost.