Pawlotsky J M, Prescott L, Simmonds P, Pellet C, Laurent-Puig P, Labonne C, Darthuy F, Remire J, Duval J, Buffet C, Etienne J P, Dhumeaux D, Dussaix E
Department of Bacteriology and Virology, Hôpital Henri Mondor, Université Paris XII, Créteil, France.
J Clin Microbiol. 1997 Jul;35(7):1734-9. doi: 10.1128/jcm.35.7.1734-1739.1997.
In patients with chronic hepatitis C, determination of hepatitis C virus (HCV) genotype could be routinely run in the future to tailor treatment schedules. The suitabilities of two versions of a serological, so-called serotyping assay (Murex HCV Serotyping Assay version 1-3 [SA1-3] and Murex HCV Serotyping Assay version 1-6 [SA1-6]; Murex Diagnostics Ltd.), based on the detection of genotype-specific antibodies directed to epitopes encoded by the NS4 region of the genome, for the routine determination of HCV genotypes were studied. The results were compared with those of a molecular biology-based genotyping method (HCV Line Probe Assay [INNO-LiPA HCV]; Innogenetics S.A.), based on hybridization of PCR products onto genotype-specific probes designed in the 5' noncoding region of the genome, obtained with pretreatment serum samples from 88 patients with chronic hepatitis C eligible for interferon therapy. Definitive genotyping was performed by sequence analysis of three regions of the viral genome in all samples with discrepant typing results found among at least two of the three assays studied. In all instances, sequence analysis confirmed the result of the INNO-LiPA HCV test. The sensitivity of SA1-3 was 75% relative to the results obtained by the genotyping assay. The results were concordant with those of genotyping for 92% of the samples typeable by SA1-3. The sensitivity of SA1-6 was 89% relative to the results obtained by the genotyping assay. The results were concordant with those of genotyping for 94% of the samples typeable by SA1-6. Overall, SA1-6 had increased sensitivity relative to SA1-3 but remained less sensitive than the genotyping assay on the basis of PCR amplification of HCV RNA. Cross-reactivities between different HCV genotypes could be responsible for the mistyping of 8 (SA1-3) and 6% (SA1-6) of the samples. Subtyping of 1a and 1b is still not possible with the existing peptides, but discriminating between subtypes may not be necessary for routine use.
在慢性丙型肝炎患者中，未来可能会常规检测丙型肝炎病毒（HCV）基因型以制定个性化治疗方案。研究了两种基于血清学的所谓血清分型检测方法（Murex HCV血清分型检测方法1 - 3版[SA1 - 3]和Murex HCV血清分型检测方法1 - 6版[SA1 - 6]；Murex诊断有限公司）对于HCV基因型常规检测的适用性，这两种方法基于检测针对基因组NS4区域编码表位的基因型特异性抗体。将结果与基于分子生物学的基因分型方法（HCV线性探针检测法[INNO - LiPA HCV]；Innogenetics公司）进行比较，该方法基于PCR产物与基因组5'非编码区设计的基因型特异性探针杂交，研究对象为88例符合干扰素治疗条件的慢性丙型肝炎患者的预处理血清样本。对所有在至少两种研究检测方法中出现分型结果不一致的样本，通过对病毒基因组三个区域进行序列分析来进行最终基因分型。在所有情况下，序列分析均证实了INNO - LiPA HCV检测的结果。相对于基因分型检测结果，SA1 - 3的灵敏度为75%。SA1 - 3可分型样本中92%的结果与基因分型结果一致。相对于基因分型检测结果，SA1 - 6的灵敏度为89%。SA1 - 6可分型样本中94%的结果与基因分型结果一致。总体而言，SA1 - 6相对于SA1 - 3灵敏度有所提高，但仍低于基于HCV RNA PCR扩增的基因分型检测方法。不同HCV基因型之间的交叉反应可能导致8%（SA1 - 3）和6%（SA1 - 6）的样本出现分型错误。现有肽段仍无法对1a和1b亚型进行分型，但对于常规应用而言，区分亚型可能并非必要。
