Halfon P, Ouzan D, Khiri H, Feryn J M
Laboratoire Alphabio, Marseille, France.
J Med Virol. 1997 Aug;52(4):391-5. doi: 10.1002/(sici)1096-9071(199708)52:4<391::aid-jmv8>3.0.co;2-x.
Hepatitis C virus (HCV) genotypes can be established by methods based on PCR typing and serological typing. The accuracy of these methods depends on their sensitivity and specificity. These should be compared with the reference method, direct sequencing, and analysis of viral genomes. Among the serologic methods recently developed, the performance of a new serotyping assay (RIBA HCV 3.0 SIA, Chiron corporation, Emeryville) was assessed using a panel of 147 well-characterized French isolates from chronic hepatitis C patients. Definitive genotypes of the isolates were established by direct sequencing in 5' NC and in some cases in NS-5B. HCV serotypes 1, 2, and 3 were determined by measuring type specific antibodies to core and NS-4 derived peptide antigens. Of the 147 sera, serotypic-specific antibodies were detected in 136 (sensitivity, 92.5%). The specificity of the RIBA SIA HCV serotyping assay was 92.6% (including samples with mixed results); without these, the specificity was 80.1%. Analysis of the 28 discrepant samples showed that (1) a different serotype was found in 18 samples including five for genotype 1, three for genotype 2, two for genotype 3, five for genotype 4, and three for genotype 5, and that (2) ten patients showed a reactivity with mixed serotypes, one had circulating antibodies to type 1 or 2, and nine had circulating antibodies to type 1 or 3. In summary, except for genotypes 4 and 5, the results of the test were well correlated (85.7%) with those of direct sequence genotyping. The former test is rapid and does not require the strict HCV RNA storage and preservation conditions of the latter. This new method may thus be considered as an alternative for HCV typing. However, although it is convenient, its lower sensitivity compared to the molecular typing method and the discrepant results limit its routine use in a clinical context.
丙型肝炎病毒（HCV）基因型可通过基于聚合酶链反应（PCR）分型和血清学分型的方法来确定。这些方法的准确性取决于其敏感性和特异性。应将这些方法与参考方法（直接测序和病毒基因组分析）进行比较。在最近开发的血清学方法中，使用一组来自147例法国慢性丙型肝炎患者的特征明确的分离株，对一种新的血清学分型检测方法（RIBA HCV 3.0 SIA，Chiron公司，埃默里维尔）的性能进行了评估。通过对5'非编码区（NC）以及某些情况下对NS-5B进行直接测序，确定了分离株的确切基因型。通过检测针对核心抗原和NS-4衍生肽抗原的型特异性抗体来确定HCV血清型1、2和3。在147份血清中，136份检测到血清型特异性抗体（敏感性为92.5%）。RIBA SIA HCV血清学分型检测方法的特异性为92.6%（包括结果混合的样本）；不包括这些样本时，特异性为80.1%。对28份结果不一致的样本进行分析发现：（1）18份样本中发现了不同的血清型，其中5份为基因型1，3份为基因型2，2份为基因型3，5份为基因型4，3份为基因型5；（2）10例患者表现出混合血清型反应性，1例有针对1型或2型的循环抗体，9例有针对1型或3型的循环抗体。总之，除基因型4和5外，该检测结果与直接序列基因分型结果具有良好的相关性（85.7%）。前一种检测方法快速，且不需要后一种方法所需的严格的HCV RNA储存和保存条件。因此，这种新方法可被视为HCV分型的一种替代方法。然而，尽管它很方便，但其与分子分型方法相比敏感性较低以及结果不一致限制了其在临床环境中的常规应用。
