对我国血站实施核酸检测后输血传播HIV残余风险度的评估  

Evaluation of the residual risk of HIV transmission through blood transfusion after nucleic acid testing in blood centers in China

作　　者：万艳红 甄志军 李莹[3] 何燕琴 燕锋[5] 张冬民[6] 许守广 吴南 李可今 沈有华 鲍琳 曹晓莉[12] 杜霞[13] 钟建玲 冯惟萍[15] 汪鹏 李莹[17] 郭咚 刘洋 李丽[20] 樊新艳 周军兵 孙晓通 周丽君[24] 能利萍 居兵[26] 王芳[27] 邱艳[28] Wan Yanhong;Zhen Zhijun;Li Ying;He Yanqin;Yan Feng;Zhang Dongmin;Xu Shouguang;Wu Nan;Li Kejin;Shen Youhua;Bao Lin;Cao Xiaoli;Du Xia;Zhong Jianling;Feng Weiping;Wang Peng;Li Ying;Guo Dong;Liu Yang;Li Li;Fan Xinyan;Zhou Junbing;Sun Xiaotong;Zhou Lijun;Neng Liping;Ju Bing;Wang Fang;Qiu Yan(Taiyuan Blood Center,Taiyuan 030024,China;Xingtai Central Blood Station,Xingtai 054005,China;Baoding Central Blood Station,Baoding 071051,China;Ganzhou Central Blood Station,Ganzhou 341001,China;Handan Central Blood Station,Handan 056005,China;Taizhou Central Blood Station,Taizhou 225306,China;Yangzhou Central Blood Station,Yangzhou 225007,China;Inner Mongolia Blood Center,Hohhot 010041,China;Ningxia Hui Autonomous Region Blood Center,Yinchuan 750002,China;Shangrao Central Blood Station 334099,China;Yichun Central Blood Station,Yichun 336028,China;Shanxi Provincial Blood Center,Xi’an 710061,China;Kunming Blood Center of Yunnan Province,Kunming 650106,China;Xianyang Central Blood Station,Xianyang 712046,China;Red Cross Blood Center of Gansu Province,Lanzhou 730046,China;Bijie Central Blood Center,Bijie 551799,China;Jiangxi Provincial Blood Center,Nanchang 330052,China;Changsha Blood Center,Changsha 410026,China;Nanjing Red Cross Blood Center,Nanjing 210024,China;Huai’an Central Blood Center,Huai’an 223021,China;Puyang Central Blood Station,Puyang 457005,China;Yancheng Central Blood Station,Yancheng 224055,China;Qingdao Central Blood Station,Qingdao 266073,China;Urumqi Blood Center,Urumqi 830000,China;Henan Provincial Red Cross Blood Center,Zhengzhou 450012,China;Shandong Provincial Blood Center,Jinan 250014,China;Liaoning Provincial Blood Center,Shenyang 110096,China;Beijing Red Cross Blood Center,Beijing 100088,China)

机构地区：[1]太原市血液中心,太原030024 [2]邢台市中心血站,邢台054005 [3]保定市中心血站,保定071051 [4]赣州市中心血站,赣州341001 [5]邯郸市中心血站,邯郸056005 [6]泰州市中心血站,泰州225306 [7]扬州市中心血站,扬州225007 [8]内蒙古自治区血液中心,呼和浩特010041 [9]宁夏回族自治区血液中心,银川750002 [10]上饶市中心血站,334099 [11]宜春市中心血站,宜春336028 [12]陕西省血液中心,西安710061 [13]云南昆明血液中心,昆明650106 [14]咸阳市中心血站,咸阳712046 [15]甘肃省红十字血液中心,兰州730046 [16]毕节市中心血站,毕节551799 [17]江西省血液中心,南昌330052 [18]长沙血液中心,长沙410026 [19]南京红十字血液中心,南京210024 [20]淮安市中心血站,淮安223021 [21]濮阳市中心血站,濮阳457005 [22]盐城市中心血站,盐城224055 [23]青岛市中心血站,青岛266073 [24]乌鲁木齐市血液中心,乌鲁木齐830000 [25]河南省红十字血液中心,郑州450012 [26]山东省血液中心,济南250014 [27]辽宁省血液中心,沈阳110096 [28]北京市红十字血液中心,北京100088

出　　处：《中华实验和临床病毒学杂志》2023年第4期361-366,共6页Chinese Journal of Experimental and Clinical Virology

摘　　要：目的评价我国血站血液检测引入核酸扩增检测(nucleic amplification test,NAT)后输血传播HIV(transfusion transmitted HIV,TT-HIV)的残余风险度(residual risk,RR)。方法收集中国采供血机构执业比对工作平台28家血站2017—2020年献血者数据和HIV感染标志物检测数据,利用新感染率/窗口期数学模型对2遍ELISA加1遍NAT单检或混检(2ELISA+ID-NAT/MP-NAT)和2遍ELISA加1遍NAT混检(2ELISA+MP-NAT)2种血液筛查(血筛)策略,估算在不同献血年份的初次献血者(first donor,FD)和重复献血者(repeated donor,RD)血液HIV检测的RR,经t检验统计学分析,比较2种血筛策略不同献血年份的FD和RD的TT-HIV RR的差异,同时观察2种血筛策略中各年间不同献血者HIV检测RR变化趋势。结果2017—2020年间,2ELISA+ID-NAT/MP-NAT血筛策略中FD的RR分别为2.869/百万人/年(10^(6)py)、3.795/10^(6)py、3.879/10^(6)py和2.890/10^(6)py,RD的RR分别为1.797/10^(6)py、1.502/10^(6)py、1.857/10^(6)py和1.483/10^(6)py,FD与RD的RR比较F=9.898,p<0.05,差异有统计学意义。2ELISA+MP-NAT血筛策略中FD的RR分别为3.508/10^(6)py、1.868/10^(6)py、2.204/10^(6)py和1.765/10^(6)py,RD的RR分别为0.948/10^(6)py、0.926/10^(6)py、0.748/10^(6)py和0.682/10^(6)py,FD与RD的RR比较F=17.126,P<0.05,有统计学差异;2种血筛策略中FD之间RR比较F=3.493,P>0.05,无差异;RD之间RR比较F=24.516,P<0.05,有差异;全部献血者(total donor,TD)之间RR比较F=20.216,P<0.05,有差异。趋势图表明无论哪种血筛策略FD的RR均大于RD。结论我国血站血液检测引入NAT后血液传播HIV的RR显著下降。不同血筛策略对HIV检测的RR存在一定差异。不同献血人群的HIV检测RR有明显差别,RD相对于FD是HIV低风险献血人群。Objective To evaluate the residual risk(RR)of transfusion transmitted HIV(TT-HIV)after the implementation of nucleic acid amplification test(NAT)in blood screening test among blood centers in China.Methods The data of blood donors and HIV infection markers from 2017 to 2020 were collected from 28 blood centers via the Platform of Comparison of blood establishments Practice in Chinese Mainland.The new infection rate/window period mathematical model was used for two types of blood screening strategies,namely,two rounds ELISA plus individual NAT take turn with pooling NAT(2ELISA+ID-NAT/MP-NAT)and two ELISA plus one round pooling NAT(2ELISA+MP-NAT),and the RR of HIV infection was estimated also based on first donors(FDs)and repeated donors(RDs)in different blood donation years.T-test analyses were conducted for comparing TT HIV RR among FDs and RDs in different blood donation years with two blood screening strategies,and the variation trend of RR in HIV test was observed.Results From 2017 to 2020,the RR of FDs in 2ELISA+ID-NAT/MP-NAT blood screening strategy was 2.869/10^(6) person-year,3.795/10^(6) persons-year,3.879/10^(6) person-year,and 2.890/10^(6) person-year respectively.The RR of RDs was 1.797/10^(6) person-year,1.502/10^(6) person-year,1.857/10^(6) person-year,and 1.483/10^(6) person-year respectively.Significant difference exists between RR of FDs and RDs,with F=9.898 and p<0.05.In 2ELISA+MP-NAT strategy,the RR of FDs was 3.508/10^(6) person-year,1.868/10^(6) person-year,2.204/10^(6) person-year,and 1.765/10^(6) person-year respectively.The RR of RDs was 0.948/10^(6) person-year,0.926/10^(6) person-year,0.748/10^(6) person-year,and 0.682/10^(6) person-year respectively.Statistical difference existed between RR of FDs and RDs,with F=17.126 and P<0.05.There was no significant difference between the RR of FDs in these two strategies with F=3.493 and P>0.05,while there was a difference between the RR of RDs in these two strategies with F=24.516 and P<0.05,and a difference between the RR of total donors(TDs)in t

关 键 词：输血 HIV 窗口期 残余风险度 首次献血者 重复献血者 

分 类 号：R512.91[医药卫生—内科学] R457.1[医药卫生—临床医学]