无偿献血者抗-HCV筛查与RIBA补充实验情况的综合分析  

Analysis of anti-HCV screening and the use of RIBA method as confirmatory tests in volunteer blood donors

作　　者：钟江[1] 陈文霞[1] 刘玉姣[1] 王军[1] 蔡健[1] 

机构地区：[1]贵州省血液中心,贵州贵阳550001

出　　处：《中国输血杂志》2016年第6期616-619,共4页Chinese Journal of Blood Transfusion

摘　　要：目的评估献血人群抗-HCV ELISA试剂的初筛效果、重组免疫印迹试验(RIBA补充实验)和HCV RNA核酸检测的情况,以探索无偿献血人群抗-HCV的筛查效果。方法收集2013年5月31日-2015年1月20日118 350例标本,采用2个不同厂家抗-HCV ELISA初筛试剂检测,初筛有反应性的标本(S/CO≥0.75)采用RIBA的方法进行补充实验,RIBA补充实验不确定结果的标本进行核酸检测。结果 2种初筛酶免试剂检测结果的阳性符合率为64.6%,阴性符合率为99.9%,总符合率为99.9%。北京万泰抗-HCV抗体诊断试剂盒检测阳性标本93.3%分布于S/CO≥10.0以上,上海科华抗-HCV抗体诊断试剂盒检测阳性标本91.3%分布于S/CO≥7.0以上。2种初筛试剂单边阳性的结果中,RIBA补充实验总阳性结果的比例为2.7%,不确定结果的比例为18.4%,阴性结果的比例为78.9%,北京万泰试剂单边阳性对应有2例RIBA阳性结果,上海科华试剂单边阳性对应有1例RIBA阳性结果,2种试剂检测性能具有一定的互补性。初筛单边阳性及RIBA补充实验结果为不确定的标本核酸检测均为阴性。RIBA阳性标本条带分析结果中,Core、NS3、NS4.1、NS4.2、NS5条带所占的比例分别为35.4%、33.9%、14.9%、2.4%、13.4%;RIBA不确定结果中,仅有Core、NS3 2种条带,比例为49.2%、50.8%。结论在献血人群中抗-HCV ELISA试剂检测存在生物学上的假阳性,一定程度上造成血液资源的浪费,选择灵敏度高、特异性好的初筛试剂,辅以RIBA补充实验,对于保证输血安全具有非常重要的意义。Objective To assess the efficacy of anti-HCV ELISA screening,anti-HCV RIBA confirmation and HCV nucleic acid testing,and to explore the impact of screening on HCV infection in blood donors. Methods Two different manufacturers of anti-HCV ELISA reagents for HCV screening were used to screen 118 350 blood donors from September 15 th,2010 to August 15 th,2012. Screening reactive specimens（ S / CO≥0. 75） using RIBA method was used to confirm. Uncertain results from RIBA method were further screened by nucleic acid test. Results Both positive ELISA screening test results were consistent with the reagent at 64. 6%. The negative coincidence rate was 99. 9%. The total coincidence rate was99. 9%. Beijing Wantai anti-HCV antibody diagnostic kit to detect positive samples achieved 93. 3% and was distributed at S / CO≥10. 0 above,while Shanghai Kehua anti-HCV antibody diagnostic kit reached 91. 3% and was distributed at S / CO≥7. 0 and above. Among the two screening agents with unilateral positive results,the proportion of RIBA positive results was2. 7%,the proportion of indeterminate results was 18. 4%,and the proportion of negative results was 78. 9%. Beijing Wantai reagents had two corresponding RIBA positive results,while Shanghai had one corresponding RIBA positive result. Both reagents were complementary to each other. Positive results in screening test and inconclusive results in RIBA using nucleic acid test deemed the result negative. Among the positive RIBA results,the proportions occupied by core,NS3,NS4. 1,NS4. 2,NS5 bands were 35. 4%,33. 9%,14. 9%,2. 4% and 13. 4% in RIBA positive results. Among inconclusive RIBA results,the proportion of core and NS3 bands were 49. 2% and 50. 8%. Conclusion In blood donors,there exists false positives determined by anti-HCV ELISA test,which has caused unnecessary waste of blood resources to some extent. Thus,choosing a combined reagent with high sensitivity and good specificity,along with the use of RIBA method to detect,carries very important significance in ensuring

关 键 词：献血者 抗-HCV 重组免疫印迹试验 

分 类 号：R446.6[医药卫生—诊断学]