【作者】 邱艳； 杨海平； 查祎； 王祎； 孙莉； 修冰水；

【Author】 Yan Qiu,Hai-Ping Yang,Yi Zha,et al.Beijing Red Cross Blood Center,100088, Beijing,China

【机构】 北京红十字血液中心； 军事医学科学院基础输血研究所；

【摘要】 目的比较ORTHO HCV 3.0 ELISA试剂长短两种孵育试验过程在血液筛查中是否存在差别方法随机挑选在常规血液筛查中检出的抗-HCV有反应性的标本,对其RNA进行检测,并用RIBA和不同于常规抗-HCV筛查的抗-HCV ELISA试剂对其抗-HCV进行检测。依据ORTHO HCV 3.0 ELISA检测试剂说明书中的两种检测程序,同时用对库存180份该类标本进行对比检测。结果 16份标本的检测结果不一致,长孵育试验过程漏检3份确证阳性的标准并有2份假阳性的结果 ,其灵敏度高于短孵育试验方法。两种试验方法的S/Co值分布没有差别,但RIBA不确定的标本其S/Co在一定的灰区范围内。结论在新献血者比例较高的献血人群,采用高灵敏度的试验方法和设定合理的结果判定灰区,有助于预防输血传播HCV,提高血液的安全。更多还原

【Abstract】 Aim Compare the two test procedures of ORTHO HCV 3.0 ELISA test system and check if the two procedures exit the difference for the blood donor screening Methods A total of 180 storage samples, detected out in the routine blood donor anti-HCV screening with different anti-HCV ELISA tests and supplemented the results with RNA,ALT,RIBA and the others anti-HCV ELISA test,were used to compare the two test procedures of ORTHO HCV 3.0 ELISA test which were described no any difference to the test results in the operation instruction manual.The trials were performed under the same experimental condition. Results 16 samples were with discordant results.Three confirmed anti-HCV positive samples were missed by short incubation test procedure and two confirmed anti-HCV negative samples were reactive with standard incubation test procedure.The standard incubation test procedure of ORTHO HCV 3.0 ELISA is much more sensitivity and lower specificity than the short one.The S/Co value distribution between two test procedures was no significant different,but some of the S/Co values of RIBA indeterminate samples were within certain range of the gray zone.Conclusion for the blood donor population with high ratio of first time donation and high rate of HCV infections,the choice of the anti-HCV screening test should be the much more sensitive in order to prevent the transfusion transmitted infected diseases and the gray zone fix is also necessary both for weak reactive and indeterminate specimens.更多还原