Héjjas M, Medgyesi G A, Falus A, Hajnal A, Forster T, Szabó J
National Institute of Haematology, Blood Transfusion and Immunology, Budapest, Hungary.
Transfus Med. 1994 Dec;4(4):273-80. doi: 10.1111/j.1365-3148.1994.tb00264.x.
Routine screening of Hungarian blood donors for anti-HCV commenced in the second half of 1992. Before this, five available anti-HCV ELISA kits were compared in pilot studies. In the first series, 831 random donor samples were tested by one of the tests and the 12 (1.4%) reactives found were retested by the other four. Six of the reactives were positive in all ELISA. In the second series, 325 samples from donors with elevated transaminase levels were tested by all five kits. Forty-four were found to be reactive by one or more of the tests and 32 (10%) were positive in all five assays. Samples concordantly reactive in the ELISA were positive in second or third generation recombinant immunoblot assay (RIBA 2 or RIBA 3); those that gave discordant results were indeterminate or negative. Eleven concordantly reactive samples from the second series were HCV RNA positive by polymerase chain reaction (PCR). In the first period of screening with Abbott ELISA 2 a repeat-reactivity rate of 0.98% was observed in 171,106 samples tested. Reactives were retested for supplementary testing by Wellcozyme anti-HCV. Donors reactive in both tests and strongly reactive (ELISA ratio (ER) = optical density/cut off > or = 2.5) in either of them were permanently deferred. Those negative in the supplementary ELISA or weakly reactive (1.0 < or = ER < 2.5) in both tests were subjected to RIBA 2. On the basis of RIBA, positive donors were permanently deferred, indeterminates were excluded for 1 year and negatives were readmitted. In 1992, 1,347 supplementary tests were completed; 824 (61%) of the respective donors were permanently deferred, 218 (16%) were deferred for 1 year and 305 (23%) were readmitted.
匈牙利自1992年下半年开始对献血者进行常规抗丙型肝炎病毒（anti-HCV）筛查。在此之前，先在试点研究中对五种现有的抗HCV酶联免疫吸附测定（ELISA）试剂盒进行了比较。在第一个系列中，用其中一种检测方法对831份随机抽取的献血者样本进行检测，检测出的12份（1.4%）反应性样本再用其他四种方法进行复测。其中6份反应性样本在所有ELISA检测中均呈阳性。在第二个系列中，用所有五种试剂盒对325份转氨酶水平升高的献血者样本进行检测。通过一种或多种检测方法发现44份样本呈反应性，其中32份（10%）在所有五种检测中均呈阳性。ELISA检测结果一致呈反应性的样本在第二代或第三代重组免疫印迹试验（RIBA 2或RIBA 3）中呈阳性；结果不一致的样本结果不确定或为阴性。第二个系列中11份结果一致呈反应性的样本通过聚合酶链反应（PCR）检测HCV RNA呈阳性。在用雅培ELISA 2进行筛查的第一阶段，在检测的171,106份样本中观察到重复反应率为0.98%。对反应性样本用Wellcozyme抗HCV进行补充检测。在两种检测中均呈反应性且在其中任何一种检测中呈强反应性（ELISA比值（ER）=光密度/临界值≥2.5）的献血者被永久延期献血。在补充ELISA检测中呈阴性或在两种检测中均呈弱反应性（1.0≤ER＜2.5）的献血者接受RIBA 2检测。根据RIBA检测结果，呈阳性的献血者被永久延期献血，结果不确定的献血者被排除1年，呈阴性的献血者重新被允许献血。1992年，共完成了1347次补充检测；相应献血者中824人（61%）被永久延期献血，218人（16%）被延期1年，305人（23%）重新被允许献血。
