Wang J T, Wang T H, Sheu J C, Tsai S J, Hsieh Y S, Lin D T, Wang C Y, Chen D S
Department of Internal Medicine and Clinical Pathology, National Taiwan University Hospital, Taipei.
Arch Pathol Lab Med. 1993 Feb;117(2):152-6.
A total of 2671 plasma samples that were selected from 22,500 volunteer blood donors in Taiwan were studied for hepatitis C virus (HCV) infection. The donors were stratified into three groups by serum alanine aminotransferase (ALT) levels. Of the donors, 20,768 (92.3%) had an ALT level less than 30 IU/L (group 1), 1080 (4.8%) had an ALT level between 31 and 45 IU/L (group 2), and 652 (2.9%) had an ALT level greater than 45 IU/L (group 3). To study anti-C100-3 hepatitis C antibody, 2023 plasma samples (10%) from group 1, 321 (30%) from group 2, and 327 (50%) from group 3 were randomly selected and tested. Twenty-one (1.04%) of group 1 donors, 13 (4.05%) of group 2 donors, and 26 (7.95%) of group 3 donors were positive for anti-C100-3, respectively. These seropositive samples were further tested by a recombinant immunoblot assay, by a polymerase chain reaction for HCV RNA, by a second-generation recombinant antigen-based immunoassay (r-HCV), and by a synthetic peptide-based immunoassay (EIA3) for HCV antibodies. By the polymerase chain reaction, 26 of the 60 donors were positive for HCV RNA. The HCV RNA was more frequently found in donors with an ALT level greater than 45 IU/L than in those with an ALT level less than 45 IU/L (15 of 26 vs nine of 34, respectively); in donors who were recombinant immunoblot assay reactive or indeterminate than in those who were recombinant immunoblot assay negative (17 of 21 or seven of 14 vs two of 25, respectively); and in donors who were EIA3 positive (25 of 33 vs one of 27) or r-HCV positive (25 of 35 vs one of 25). Based on these data, we anticipate that screening by anti-C100-3 in Taiwan will exclude approximately 3280 potentially infectious donations under the current screening policy but will result in the loss of 6860 donations that will be negative for HCV RNA per year. Because of its high sensitivity and specificity, EIA3 or r-HCV seems to be a potentially better screening method for HCV carriers.
从台湾22500名无偿献血者中选取了2671份血浆样本，用于研究丙型肝炎病毒（HCV）感染情况。根据血清丙氨酸氨基转移酶（ALT）水平，将这些献血者分为三组。其中，20768名（92.3%）献血者的ALT水平低于30 IU/L（第1组），1080名（4.8%）献血者的ALT水平在31至45 IU/L之间（第2组），652名（2.9%）献血者的ALT水平高于45 IU/L（第3组）。为研究抗C100 - 3丙型肝炎抗体，从第1组中随机选取了2023份血浆样本（10%），第2组中选取了321份（30%），第3组中选取了327份（50%）进行检测。第1组献血者中21名（1.04%）、第2组献血者中13名（4.05%）、第3组献血者中26名（7.95%）的抗C100 - 3检测呈阳性。对这些血清学阳性样本进一步采用重组免疫印迹法、HCV RNA聚合酶链反应、第二代基于重组抗原的免疫测定法（r - HCV）以及基于合成肽的HCV抗体免疫测定法（EIA3）进行检测。通过聚合酶链反应，60名献血者中有26名HCV RNA检测呈阳性。ALT水平高于45 IU/L的献血者中HCV RNA的检出频率高于ALT水平低于45 IU/L的献血者（分别为26例中的15例和34例中的9例）；重组免疫印迹法反应性或结果不确定的献血者中HCV RNA的检出频率高于重组免疫印迹法阴性的献血者（分别为21例中的17例或14例中的7例和25例中的2例）；EIA3阳性的献血者（33例中的25例）或r - HCV阳性的献血者（35例中的25例）中HCV RNA的检出频率高于相应阴性献血者（分别为27例中的1例和25例中的1例）。基于这些数据我们预计，按照台湾目前的筛查政策，采用抗C-100-3进行筛查每年将排除约3280份可能具有传染性的献血，但会导致6860份HCV RNA检测呈阴性的献血被弃用。由于EIA3或r - HCV具有高灵敏度和高特异性，似乎是一种对HCV携带者潜在更好的筛查方法。
