ELISA单试剂抗-HCV反应性献血者的HCV基因分型及归队研究  

HCV genotyping of anti-HCV reactive samples by one ELISA assay and blood donor reentry study

作　　者：向庆林 张天弼 霍宝锋 张国英 李慧文 梁海燕 郑静敏 张弢 XIANG Qinglin;ZHANG Tianbi;HUO Baofeng;ZHANG Guoying;LI Huiwen;LIANG Haiyan;ZHENG JingMin;ZHANG Tao(Shaoguan Central Blood Station,Shaoguan 512026,China;Southern Air Force Hospital)

机构地区：[1]韶关市中心血站,广东韶关512026 [2]南部战区空军医院

出　　处：《中国输血杂志》2021年第8期889-891,共3页Chinese Journal of Blood Transfusion

摘　　要：目的了解ELISA单试剂筛查抗-HCV反应性献血者HCV基因(型),为抗-HCV假阳性献血者归队提供科学依据。方法从韶关市中心血站献血者信息系统中,提取2014年1月1日~2018年12月31日453名用第3代ELISA单试剂检测抗-HCV反应性献血者信息,电话召回本人到站采集其静脉血标本3管(5 mL/管),做血清学(第4代ELISA试剂)和PCR定性检测,PCR检测有反应者送基因检测实验室做HCV基因分型以便指导其下一步的诊断和治疗;阴性者按中国输血协会《血液筛查反应性献血者归队指南》做献血者归队处理。结果本组第3代ELISA单试剂检测抗-HCV反应性献血者的应召采集血液标本的比例为70.2%(318/453);HCV基因检测:阴性者比例83.0%(264/318),阳性者为17.0%(54/318);阳性者HCV亚型分布HCV2a>1b>3a=6a。第3代试剂反应率为0.41%,第4代试剂反应率为0.06%。经过2轮归队程序,98位献血者可以回归献血者队伍,回归率21.63%(98/453)。结论HCV RNA定性及HCV基因型分型检测证实第3代及其前代ELISA单试剂检测献血者抗-HCV反应性过高且其中绝大部分实为HCV阴性者;故对这部分献血者做NAT或(和)HCV基因分型,确定阳性者以永久屏蔽,阴性者转入献血者归队程序。Objective To investigate the genotype of anti-HCV reactive blood donors by one ELISA assay and provide scientific basis for the reentry of anti-HCV false positive blood donors.Methods The data of 453 blood donors reactive to antibody to HCV(anti-HCV)with one ELISA assay(third generation)were extracted via the blood donor information system of Shaoguan Central Blood Station from January 1,2014 to December 31,2018.The subjects were recalled to the station for the serological retest,using a 4th generation ELISA reagent,and PCR qualitative test.The PCR reactive samples were sent to the genetic testing laboratory for HCV genotyping,in order to guide diagnosis and treatment in the future.Meanwhile,those PCR negative blood donors returned to be eligible again based on the Guidelines for the Return of Reactive Blood Donors for Blood Screening.Results 70.2%(318/453)of the previous anti-HCV-reactive blood donors,using a third-generation ELISA assay responded to the HCV genotyping,of which 83.0%(264/318)were negative,and 17%(54/318)positive.The profile of HCV subtypes in positive donors was HCV2a>1b>3a=6a.A little bit high false positive rate was presented by the third,and former,generation reagent than the four generation(0.41%vs 0.06%),which was confirmed by HCV RNA qualitative and HCV genotyping tests.After two rounds of reentry testing,98 eligible blood donors returned to the blood donor team,with the return rate at 21.63%(98/453).Conclusion NAT or(and)HCV genotyping for anti-HCV reactive blood donors screened out by the third,and former,generation,should be carried out to permanently shield the true positive donors and reenter the negative ones.

关 键 词：抗-HCV反应性 ELISA HCV基因分型 无偿献血者 献血者归队 

分 类 号：R446[医药卫生—诊断学] R193.3[医药卫生—临床医学]