Zaaijer H L, Vrielink H, van Exel-Oehlers P J, Cuypers H T, Lelie P N
Viral Serology Department, Central Laboratory of the Netherlands Red Cross Blood Transfusion Service, Amsterdam.
Transfusion. 1994 Jul;34(7):603-7. doi: 10.1046/j.1537-2995.1994.34794330015.x.
Recently, new immunoblot assays for the detection of antibodies to hepatitis C virus (HCV) became available.
The performance of five confirmatory anti-HCV immunoblot assays was studied with samples with known HCV antibody and HCV RNA status. The assays were a third-generation strip recombinant immunoblot assay (RIBA-3, Chiron Corp., Emeryville, CA), a second-generation HCV blot (DB-2 blot, Diagnostic Biotechnology, Singapore), the Wellcozyme HCV Western blot (Murex blot, Murex Diagnostics, Dartford, UK), an immunodot HCV assay (Matrix, Abbott Laboratories, Chicago, IL), and the third-generation HCV line immunoassay (Liatek-III, Organon Teknika, Boxtel, The Netherlands).
Sensitivity on samples from 48 HCV RNA-positive, second-generation RIBA (RIBA-2)-positive persons and specificity on samples from 31 low-risk donors was 96 percent or better for all assays. The sensitivity on 31 HCV RNA-positive, RIBA-2-indeterminate samples was as follows: Liatek-III, 94 percent; RIBA-3, 90 percent; Murex blot, 61 percent; Matrix, 55 percent; and DB-2 blot, 39 percent. In testing 39 HCV RNA-negative, RIBA-2-indeterminate donor samples, the percentage found to be negative was Liatek-III, 77 percent; RIBA-3, 67 percent; Murex blot, 49 percent; DB-2 blot, 33 percent; and Matrix, 15 percent. The order of sensitivity on four HCV seroconversion series was (from high to low): RIBA-3, Liatek-III, DB-2 blot, Murex blot, and Matrix; the differences were small.
Detection of HCV antibodies was not refined by the addition of new HCV antigens (NS5, E2/NS1), but by improved classical antigens (core, NS3, NS4). Replacement of the commonly used RIBA-2 will resolve the status of a high proportion of RIBA-2-indeterminate samples.
最近,出现了用于检测丙型肝炎病毒(HCV)抗体的新型免疫印迹检测法。
使用已知HCV抗体和HCV RNA状态的样本,对五种确证性抗HCV免疫印迹检测法的性能进行了研究。这些检测法包括第三代条带重组免疫印迹检测法(RIBA - 3,Chiron公司,加利福尼亚州埃默里维尔)、第二代HCV印迹检测法(DB - 2印迹检测法,Diagnostic Biotechnology公司,新加坡)、Wellcozyme HCV免疫印迹检测法(Murex印迹检测法,Murex Diagnostics公司,英国达特福德)、免疫斑点HCV检测法(Matrix,雅培实验室,伊利诺伊州芝加哥)以及第三代HCV线性免疫检测法(Liatek - III,Organon Teknika公司,荷兰博克斯泰尔)。
对于所有检测法,在48例HCV RNA阳性、第二代重组免疫印迹检测法(RIBA - 2)阳性患者的样本上的敏感性以及在31例低风险供体样本上的特异性均达到96%或更高。在31例HCV RNA阳性、RIBA - 2结果不确定的样本上的敏感性如下:Liatek - III为94%;RIBA - 3为90%;Murex印迹检测法为61%;Matrix为55%;DB - 2印迹检测法为39%。在检测39例HCV RNA阴性、RIBA - 2结果不确定的供体样本时,检测为阴性的百分比分别为:Liatek - III为77%;RIBA - 3为67%;Murex印迹检测法为49%;DB - 2印迹检测法为33%;Matrix为15%。在四个HCV血清转化系列样本上的敏感性顺序为(从高到低):RIBA - 3、Liatek - III、DB - 2印迹检测法、Murex印迹检测法和Matrix;差异较小。
添加新的HCV抗原(NS5、E2/NS1)并未改善HCV抗体的检测,而是改进经典抗原(核心抗原、NS3、NS4)起到了作用。取代常用的RIBA - 2将解决很大一部分RIBA - 2结果不确定样本的状况。