Kobayashi M, Chayama K, Arase Y, Tsubota A, Saitoh S, Suzuki Y, Kobayashi M, Ikeda K, Matsuda M, Koike H, Hashimoto M, Kumada H
Department of Liver Research Laboratory, Toranomon Hospital, Kawasaki, Japan.
J Gastroenterol. 1999 Aug;34(4):505-9. doi: 10.1007/s005350050304.
By conventional serological grouping methods, it is possible to determine hepatitis C virus (HCV) serological groups for genotypes 1a, and 1b, and genotypes 2a, and 2b, but not for other genotypes, i.e., 3a, 3b, 4a, 5a, and 6a. In this study, we attempted to serologically group HCV with the Murex HCV serotyping 1 to 6 assay (Murex Diagnostics, Kent, UK), using an enzyme-linked immunosorbent assay (ELISA) based on genotype-specific peptides from the NS4 region. The subjects of this study were 365 patients infected with HCV of genotype 1a, 1b, 2a, 2b, 3a, or 3b. The sensitivity of the assay was 100% in patients with genotype 1a, 82.7% in those with 1b, 68.5% in those with 2a, 84.2% in those with 2b, 50.0% in those with 3a, and 76.5% in those with genotype 3b. The overall sensitivity was 78.4%. The specificity of the assay was 100% in the subjects with genotype 1a, 98.8% in those with 1b, 98.4% in those with 2a, 96.9% in those with 2b, 100% in those with 3a, and 100% in those with genotype 3b. The overall specificity was 98.6%. The concordance of the assay was 100% in subjects with genotype la, 81.7% in those with 1b, 67.4% in those with 2a, 81.6% in those with 2b, 50.0% in those with 3a, and 76.5% in those with genotype 3b. The overall concordance was 77.5%. We believe it would be better to serotype with the Murex HCV serotyping 1 to 6 assay, if other than serological group (Gr) 1 or Gr 2 is suspected in particular ethnic groups or in subjects with an indeterminate result with the Immucheck HCV Gr assay (Kokusai, Kobe, Japan), assuming that the genotype must be other than 1a, 1b, 2a, or 2b.
通过传统的血清学分组方法,可以确定丙型肝炎病毒(HCV)1a型、1b型、2a型和2b型的血清学组,但无法确定其他基因型,即3a型、3b型、4a型、5a型和6a型的血清学组。在本研究中,我们尝试使用基于NS4区域基因型特异性肽的酶联免疫吸附测定(ELISA),通过Murex HCV血清分型1至6检测法(Murex诊断公司,英国肯特)对HCV进行血清学分组。本研究的受试者为365例感染1a型、1b型、2a型、2b型、3a型或3b型HCV的患者。该检测法在1a型患者中的敏感性为100%,在1b型患者中为82.7%,在2a型患者中为68.5%,在2b型患者中为84.2%,在3a型患者中为50.0%,在3b型患者中为76.5%。总体敏感性为78.4%。该检测法在1a型受试者中的特异性为100%,在1b型受试者中为98.8%,在2a型受试者中为98.4%,在2b型受试者中为96.9%,在3a型受试者中为100%,在3b型受试者中为100%。总体特异性为98.6%。该检测法在1a型受试者中的一致性为100%,在1b型受试者中为81.7%,在2a型受试者中为67.4%,在2b型受试者中为81.6%,在3a型受试者中为50.0%,在3b型受试者中为76.5%。总体一致性为77.5%。我们认为,如果在特定种族群体中怀疑不是血清学组(Gr)1或Gr 2,或者在使用Immucheck HCV Gr检测法(日本神户国际医疗株式会社)结果不确定的受试者中,假设基因型必须不是1a型、1b型、2a型或2b型,那么使用Murex HCV血清分型1至6检测法进行血清分型会更好。