Zheng Xiaotian, Pang Minnie, Chan Amelia, Roberto Ann, Warner Diane, Yen-Lieberman Belinda
Diagnostic Laboratory Services, The Queen's Health Systems and University of Hawaii School of Medicine, Honolulu, HI, USA.
J Clin Virol. 2003 Oct;28(2):214-6. doi: 10.1016/s1386-6532(03)00076-3.
Hepatitis C virus (HCV) is a major cause of chronic liver disease worldwide. It is associated with the development of end-stage liver disease and hepatocellular carcinoma. Studies have shown that patients infected with different genotypes of HCV may respond to interferon-ribavirin therapy differently and thus HCV genotype information is very important in helping physicians to better managing their patients.
Compare the end results of HCV typing of the two commercially available tests.
TRUGENE Genotyping test (Visible Genetics) was used to analyze clinical specimens obtained from North America. The 5' NC was amplified with the Roche COBAS Amplicor HCV Monitor Test. Amplification products were blinded and genotyped by the TRUGENE HCV 5'NC method. Genotype results were compared with those obtained by the reverse hybridization based INNO-LiPA HCV II (Innogenetics) assay. Additional sequencing of the NS5B region was done to resolve discrepancies.
Among the total of 110 consecutively collected serum specimens submitted for HCV genotyping, 108/110 could be typed by the sequencing method and 107/110 were typable by LiPA HCV II method. Our experiences with the tests suggest that at type level, HCV genotype results are 100% concordant between the two tests studied for those 106 specimens successfully typed by both methods. More sensitive amplification, such as qualitative PCR, is needed to test specimens with viral load lower than 20000 IU/ml. Both tests can be easily adapted by a clinical diagnostic laboratory.
丙型肝炎病毒（HCV）是全球慢性肝病的主要病因。它与终末期肝病和肝细胞癌的发生有关。研究表明，感染不同基因型HCV的患者对干扰素-利巴韦林治疗的反应可能不同，因此HCV基因型信息对于帮助医生更好地管理患者非常重要。
比较两种市售检测方法的HCV分型最终结果。
使用TRUGENE基因分型检测（Visible Genetics）分析从北美获取的临床标本。用罗氏COBAS Amplicor HCV监测检测法扩增5'NC。扩增产物经盲法处理后，采用TRUGENE HCV 5'NC方法进行基因分型。将基因型结果与基于反向杂交的INNO-LiPA HCV II（Innogenetics）检测法获得的结果进行比较。对NS5B区域进行额外测序以解决差异。
在总共110份连续收集的用于HCV基因分型的血清标本中，108/110份标本可用测序法分型，107/110份标本可用LiPA HCV II法分型。我们对这些检测方法的经验表明，在基因型水平上，对于两种方法均成功分型的106份标本，所研究的两种检测方法的HCV基因型结果100%一致。对于病毒载量低于20000 IU/ml的标本，需要更灵敏的扩增方法，如定性PCR。两种检测方法临床诊断实验室都能轻松采用。
