Haushofer Alexander C, Berg Jörg, Hauer René, Trubert-Exinger Doris, Stekel Herbert G, Kessler Harald H
Institute of Laboratory Medicine, General Hospital St. Pölten, A-3100 St. Pölten, Austria.
J Clin Virol. 2003 Aug;27(3):276-85. doi: 10.1016/s1386-6532(02)00183-x.
Genotyping of hepatitis C virus (HCV) is clinically relevant to epidemiology, prognosis, and therapeutical management of HCV infection.
Accuracy and specificity of three assays for HCV genotyping/subtyping were determined. The TruGene HCV 5'NC Genotyping Kit (TruGene), which is a direct sequencing test and two assays based on reversed hybridization, Inno-LiPA HCV II assay and ViennaLab HCV Strip Assay, were compared. Amplification products generated by the Cobas Amplicor HCV Test were used.
A total of 100 consecutive HCV RNA positive samples derived from patients with chronic hepatitis C were examined for their genotypes/subtypes by the three assays.
Identification of genotypes and subtypes by the TruGene assay as reference test for the Inno-LiPA HCV II assay and the ViennaLab HCV Strip Assay or Inno-LiPA HCV II assay as reference test for the TruGene and the ViennaLab HCV Strip Assay showed similar results for overall accuracies (TruGene as reference test for Inno-LiPA HCV II and ViennaLab HCV Strip Assay, genotypes/subtypes: 100%/95.5% and 97%/92%; Inno-LiPA HCV II as reference test for TruGene and ViennaLab HCV Strip Assay, genotypes/subtypes: 99%/85.9% and 97%/87.9%) and specificities (TruGene as reference test for Inno-LiPA HCV II and ViennaLab HCV Strip Assay, genotypes/subtypes: 100%/97.8% and 99%/97.7%; Inno-LiPA HCV II as reference test for TruGene and ViennaLab HCV Strip Assay, genotypes/subtypes: 100%/99.4% and 99.7%/98%).
The three assays were found to be reliable for the detection and discrimination of all HCV genotypes common in Europe and in North America and to be suitable for the routine diagnostic laboratory.
丙型肝炎病毒（HCV）基因分型在HCV感染的流行病学、预后及治疗管理方面具有临床相关性。
确定三种HCV基因分型/亚型检测方法的准确性和特异性。比较了直接测序检测方法TruGene HCV 5'NC基因分型试剂盒（TruGene）以及两种基于反向杂交的检测方法Inno-LiPA HCV II检测法和ViennaLab HCV Strip检测法。使用了Cobas Amplicor HCV检测试剂盒产生的扩增产物。
采用这三种检测方法对100例连续的慢性丙型肝炎患者的HCV RNA阳性样本进行基因分型/亚型检测。
以TruGene检测法作为Inno-LiPA HCV II检测法和ViennaLab HCV Strip检测法的参考检测，或以Inno-LiPA HCV II检测法作为TruGene检测法和ViennaLab HCV Strip检测法的参考检测，在总体准确性（以TruGene检测法作为Inno-LiPA HCV II检测法和ViennaLab HCV Strip检测法的参考检测，基因/亚型：100%/95.5%和97%/92%；以Inno-LiPA HCV II检测法作为TruGene检测法和ViennaLab HCV Strip检测法的参考检测，基因/亚型：99%/85.9%和97%/87.9%）和特异性（以TruGene检测法作为Inno-LiPA HCV II检测法和ViennaLab HCV Strip检测法的参考检测，基因/亚型：100%/97.8%和99%/97.7%；以Inno-LiPA HCV II检测法作为TruGene检测法和ViennaLab HCV Strip检测法的参考检测，基因/亚型：100%/99.4%和99.7%/98%）方面显示出相似的结果。
发现这三种检测方法在检测和区分欧洲和北美常见的所有HCV基因型方面是可靠的，适用于常规诊断实验室。
