Berger A, Doerr H W, Preiser W, Weber B
Institut für Medizinische Virologie, Zentrum der Hygiene Universitätskliniken Frankfurt a. M., Germany.
J Virol Methods. 1996 May;59(1-2):141-6. doi: 10.1016/0166-0934(96)02034-4.
Numerous 2nd and 3rd generation screening and confirmatory assays for the detection of anti-HCV antibodies have been introduced on the international market. The aim of the present study was to compare the performance of five different commercially available screening assays and four 'confirmatory' assays in a panel of serum samples that had tested positive or borderline with a 2nd generation EIA (Abbott HCV EIA 2nd generation). Considerable discrepancies were observed between the different screening assays and confirmatory tests. The antigens from the putative 'core' region of HCV were recognized most frequently by the confirmatory assays. By considering the reactivity to either NS5 (RIBA III and Inno-LIA) or E2/NS1 antigens (Inno-LIA Ab III) no sample could be identified as anti-HCV positive that would otherwise have been regarded as borderline or negative according to its banding pattern with core, NS3 and NS4 proteins. All 24 HCV-RT-PCR positive samples were anti-HCV reactive by the screening EIAs but only 18 and 21 samples were confirmed anti-HCV positive with the RIBA II and III, respectively. A clear association was observed between HCV-RNAemia in serum samples and index values (O.D. sample/O.D. cut-off) of the screening EIAs as well as with the number of reactive proteins in the confirmatory assays. In conclusion, the results of current screening and confirmatory assays are highly divergent. The additional diagnostic significance of the relatively expensive and labour-intensive immunoblots appears to be very limited. For the serological diagnosis of HCV infection and for blood donor screening, confirmatory assays should only be used if there is a borderline result by HCV EIA. The determination of infectivity by qualitative PCR and the follow-up of patients undergoing IFN therapy by HCV-RNA quantification appears to be much more useful.
国际市场上已推出众多用于检测抗丙型肝炎病毒（HCV）抗体的第二代和第三代筛查及确证检测方法。本研究的目的是比较五种不同的市售筛查检测方法和四种“确证”检测方法在一组血清样本中的性能，这些血清样本在第二代酶免疫测定（Abbott HCV EIA第二代）中检测为阳性或临界阳性。不同的筛查检测方法和确证检测之间观察到了相当大的差异。确证检测最常识别来自HCV假定“核心”区域的抗原。根据对NS5（RIBA III和Inno-LIA）或E2/NS1抗原（Inno-LIA Ab III）的反应性，没有样本可被鉴定为抗HCV阳性，否则根据其与核心、NS3和NS4蛋白的条带模式会被视为临界或阴性。所有24份HCV逆转录聚合酶链反应（RT-PCR）阳性样本通过筛查酶免疫测定均为抗HCV反应性，但分别只有18份和21份样本通过RIBA II和III确证为抗HCV阳性。在血清样本中的HCV病毒血症与筛查酶免疫测定的指数值（光密度样本/光密度临界值）以及确证检测中反应性蛋白的数量之间观察到明显关联。总之，当前筛查和确证检测的结果差异很大。相对昂贵且劳动强度大的免疫印迹的额外诊断意义似乎非常有限。对于HCV感染的血清学诊断和献血者筛查，仅当HCV EIA结果为临界值时才应使用确证检测。通过定性PCR确定感染性以及通过HCV-RNA定量对接受干扰素治疗的患者进行随访似乎更有用。
