Zeuzem S, Rüster B, Roth W K
Medizinische Klinik II, Klinikum der Johann Wolfgang Goethe-Universität, Frankfurt.
Z Gastroenterol. 1994 Jun;32(6):342-7.
Direct detection of hepatitis C virus (HCV) by reverse transcription (RT) and polymerase chain reaction (PCR) has clinical impact on diagnosis and the assessment of anti-viral therapy. However, recent results of a quality control study on the detection of HCV-RNA by RT-PCR revealed inappropriate sensitivity and specificity in the majority of participating laboratories. In this study we evaluated the first standardized RT-PCR-assay (Amplicor HCV) for routine detection of hepatitis C virus in serum samples from patients with hepatitis C (n = 111), patients with resolved acute hepatitis C (n = 7) and controls (n = 101). The Amplicor HCV assay was convenient to handle, detected all genotypes of the hepatitis C virus commonly present in Europe (type 1, 2 and 3 according to Simmonds et al.) and had a lower detection limit of 10(2)-10(3) copies as assessed by quantifiable HCV-specific RNA templates. In the clinical evaluation the Amplicor HCV system reached a sensitivity of 100% and a specificity of 97%.
通过逆转录（RT）和聚合酶链反应（PCR）直接检测丙型肝炎病毒（HCV）对诊断及抗病毒治疗评估具有临床意义。然而，近期一项关于RT-PCR检测HCV-RNA的质量控制研究结果显示，大多数参与研究的实验室在灵敏度和特异性方面存在不足。在本研究中，我们评估了首个用于常规检测丙型肝炎患者（n = 111）、已痊愈的急性丙型肝炎患者（n = 7）及对照者（n = 101）血清样本中丙型肝炎病毒的标准化RT-PCR检测方法（Amplicor HCV检测法）。Amplicor HCV检测法操作简便，能检测出欧洲常见的所有丙型肝炎病毒基因型（根据Simmonds等人的分类为1型、2型和3型），并且通过可定量的HCV特异性RNA模板评估，其检测下限为10(2)-10(3)拷贝。在临床评估中，Amplicor HCV系统的灵敏度达到100%，特异性为97%。
