安徽省采供血系统ELISA单试剂检测呈反应性献血者重新召回的检测结果分析  

A recall test analysis on previously single-ELISA-positive donors under the Anhui province blood collect & supply system

作　　者：吕蓉[1] 李素萍[1] 蒋菲菲[1] 赵阳[1] 魏家余 王超[1] 於娟[1] 赵茹 孙友岒 徐曙光 LV Rong;LI Suping;JIANG Feifei;ZHAO Yang;WEI Jiayu;WANG Chao;YU Juan;ZHAO Ru;SUN Youl- ing;XU Shuguang(Anhui Blood Center, Hefei 230031, China;Wuhu Blood Center;Huainan Blood Center;Liuan Blood Center.)

机构地区：[1]安徽省血液中心,安徽合肥230031 [2]芜湖市中心血站 [3]淮南市中心血站 [4]六安市中心血站

出　　处：《中国输血杂志》2018年第4期405-409,共5页Chinese Journal of Blood Transfusion

基　　金：安徽省合肥市卫生计生委应用医学重点项目(HWK2016zd014)

摘　　要：目的通过分析安徽省采供血系统暂时屏蔽的献血者重新召回检测结果,为制定合适的血清学检测呈反应性献血者重新召回策略提供理论依据。方法对2013年1月—2015年6月HBsAg、抗-HCV、抗-HIV、抗-TP血清学单试剂检测呈反应性的献血者,屏蔽6个月后,对其追踪采样进行相应反应性项目的检测：首先用原试剂再次进行ELISA双试剂检测,同时进行单人份核酸检测（NAT）若均为阴性送确证试验室再次进行ELISA双试剂（至少有一种试剂与原试剂不同）检测及补充血清学试验：乙型肝炎病毒核心抗体检测、HBsAg中和试验、HCV重组免疫印迹试验（RIBA）、HIV免疫印迹试验（WB）、TP梅毒螺旋体明胶颗粒凝集试验（TPPA）。结果确证实验室共检测召回样本201例,召回检测阴性119例,召回率59.2%。其中：检测HBsAg单试剂呈反应性标本65例,可重新召回献血者26例,召回率40.00%（26/65）;检测抗-HCV单试剂呈反应性标本40例,可重新召回献血者35例,召回率87.50%（35/40）;检测抗-HIV单试剂呈反应性标本46例,可重新召回献血者25例,召回率54.35%（25/46）;检测抗-TP单试剂呈反应性标本50例,可重新召回献血者33例,召回率66.00%（33/50）。结论血清学ELISA单试剂检测呈反应性献血者中有一部分是潜在合格的献血者,现行的呈反应性献血者重新召回策略具有防止合格献血者流失的积极意义,但召回检测结果仍然呈反应性献血者的进一步追踪值得探讨。Objective To analyze of test results of the blood donors who were temporarily blocked by the Anhui Blood Center due to being ELISA-positive. We believe this study would provide a theoretical references for the establishment of a sensible recall strategy for the re-entry of blood donors. Methods After being rejected for 6 months,the tracked samples with positive results in HBsAg,anti-HCV,anti-HIV,or anti-TP tests from 2014. 1 to 2015. 6 were re-tested for corresponding items： An ELISA test was first conducted with the original reagents,which was followed by NAT tests. If the results were both negative,the sample would be sent for confirmatory tests,where two ELISA reagents（at least one reagent was different from the original ones） were adopted. Other supplementary experiments,such as the HBc Ab test,HBsAg neutralization test,anti-HCV RIBA test,anti-HIV WB test and anti-TP TPPA tests,were also conducted. Results The confirmatory laboratory has received 201 tracked samples,119 of which were tested negative with a recall rate of 59. 2%. In all the samples,we tested 65 samples in the HBsAg test and 26 were negative,yielding a recall rate of 40. 00%; In the anti-HCV tests,35 of the 40 samples were negative at a recall rate of 87. 50%;In anti-HIV tests,25 of 46 samples were recalled with a recall rate of 54. 35%; In the anti-TP tests,33 of the 50（66. 00%） samples were recalled. Conclusion The single-ELISA-positive samples turned out to be potential qualified blood samples. The current recall strategy holds great significance in preventing the loss of qualified blood donors. That being said,the donors remaining positive in the recall tests may need further investigation.

关 键 词：暂时屏蔽 呈反应性献血者 核酸检测 ELISA 

分 类 号：R457.11[医药卫生—治疗学] R446.6[医药卫生—临床医学]