Progress and challenges in the laboratory diagnosis of hepatitis C virus / 中华检验医学杂志

ABSTRACT

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.