Widell A, Månsson A S, Sundström G, Hansson B G, Nordenfelt E
Department of Medical Microbiology, University of Lund, Malmö General Hospital, Sweden.
J Med Virol. 1991 Dec;35(4):253-8. doi: 10.1002/jmv.1890350409.
The low specificity of screening ELISAs for antibodies to hepatitis C virus in blood donors has called for confirmatory tests. Two types of supplementary antibody assays are available, recombinant immunoblot assays (RIBA-1 and RIBA-2) and an antibody consumption test referred to as a neutralization assay. Amplification of viral nucleic acid by the polymerase chain reaction (PCR) provides an antibody independent mode of detecting viral infection. We applied reverse transcription-double PCR to detect an HCV 5'-noncoding viral RNA sequence in serum specimens and compared PCR findings with confirmatory antibody tests. This study includes sera from 37 blood donors found positive by the Ortho anti-HCV (C100-3) ELISA out of 14,591 donations. Of the 37 positive sera, 8 were positive by RIBA-1 and 1 further by RIBA-2. Seven of the RIBA positive sera contained HCV RNA by PCR. Among the 8 indeterminate and the 21 negative donor sera by RIBA-1, no PCR positive serum was found. The 37 anti-HCV positive donor sera identified by Ortho ELISA were also tested by Abbott anti-HCV (C100-3) ELISA whereby 22 were positive. Of these 22 sera plus 1 further with ELISA OD just below cutoff, 8 were positive by the "neutralization assay," (Abbott Laboratories, North Chicago, IL, USA) and 6 of these, including the borderline serum, were PCR positive. One of the two neutralizable but PCR negative sera was RIBA positive and the other was indeterminate. However, one ELISA (Abbott Laboratories) positive (OD 1.99) serum was not neutralizable but nevertheless contained HCV RNA by PCR.(ABSTRACT TRUNCATED AT 250 WORDS)
献血者丙型肝炎病毒抗体筛查酶联免疫吸附测定（ELISA）的低特异性促使需要进行确证试验。有两种补充抗体检测方法，即重组免疫印迹试验（RIBA - 1和RIBA - 2）以及一种称为中和试验的抗体消耗试验。通过聚合酶链反应（PCR）扩增病毒核酸提供了一种独立于抗体检测病毒感染的方法。我们应用逆转录 - 双重PCR检测血清标本中丙型肝炎病毒（HCV）5' - 非编码病毒RNA序列，并将PCR结果与确证性抗体检测结果进行比较。本研究纳入了在14591份献血样本中经Ortho抗 - HCV（C100 - 3）ELISA检测呈阳性的37名献血者的血清。在这37份阳性血清中，8份经RIBA - 1检测呈阳性，另有1份经RIBA - 2检测呈阳性。7份RIBA阳性血清经PCR检测含有HCV RNA。在8份RIBA - 1检测结果不确定以及21份RIBA - 1检测为阴性的献血者血清中，未发现PCR阳性血清。经Ortho ELISA鉴定为抗 - HCV阳性的37份献血者血清也用Abbott抗 - HCV（C100 - 3）ELISA进行检测，其中22份呈阳性。在这22份血清以及另外1份ELISA OD值略低于临界值的血清中，8份经“中和试验”（美国伊利诺伊州北芝加哥市雅培实验室）检测呈阳性，其中6份，包括临界血清样本，经PCR检测呈阳性。两份可被中和但PCR检测为阴性的血清中，一份RIBA检测呈阳性，另一份结果不确定。然而，一份ELISA（雅培实验室）检测呈阳性（OD值为1.99）的血清不可被中和，但经PCR检测仍含有HCV RNA（摘要截短于250字）
