京津冀地区血站实验室HBsAg检测复检符合率分析  

Analysis of the concordance rate of HBsAg retest results in the blood station laboratories in Beijing-Tianjin-Hebei region

作　　者：秦倩倩 葛红卫[1] 王瑞[1] 潘彤 韩卫[3] 王鹏 杨莉 孙绍秋[6] 曹晓[6] 崔立晔 魏超 于桂军 徐云鹏 房金娟 刘彩侠 王学刚[12] 甄志军 刘晓杰 杜文功 王露楠 刘江[1] 王鸿捷[1] QIN Qianqian;GE Hongwei;WANG Rui;PAN Tong;HAN Wei;WANG Peng;YANG Li;SUN Shaoqiu;CAO Xiao;CUI Liye;WEI Chao;YU Guijun;XU Yunpeng;FANG Jinjuan;LIU Caixia;WANG Xuegang;ZHEN Zhijun;LIU Xiaojie;DU Wengong;WANG Lunan;LIU Jiang;WANG Hongjie(BeijingRed Cross Blood Center,Beijing 100088,China;Tianjin Blood Center;Hebei Blood Center;Tongzhou Blood Bank;Tanggu Blood Bank;Tangshan Blood Bank;Baoding Blood Bank;Cangzhou Blood Bank;Zhangjiakou Blood Bank;Hengshui Blood Bank;Chengde Blood Bank;Handan Blood Bank;Xingtai Blood Bank;Qinhuangdao Blood Bank;Langfang Blood Bank;National Center for Clinical Laboratories)

机构地区：[1]北京市红十字血液中心,北京100088 [2]天津市血液中心 [3]河北省血液中心 [4]北京市通州区血站 [5]天津市塘沽中心血站 [6]唐山市中心血站 [7]保定市中心血站 [8]沧州市中心血站 [9]张家口市中心血站 [10]衡水市中心血站 [11]承德市中心血站 [12]邯郸市中心血站 [13]邢台市中心血站 [14]秦皇岛市中心血站 [15]廊坊市中心血站 [16]国家卫健委临检中心

出　　处：《中国输血杂志》2020年第3期189-194,共6页Chinese Journal of Blood Transfusion

摘　　要：目的分析北京、天津、河北地区血站实验室2018年的HBsAg ELISA检测复检符合率情况,探究各实验室HBsAg检测能力差异及影响因素,为实现各地区血站实验室同质化打下基础。方法通过问卷填报的形式,收集2018年北京、天津、河北地区15家血站实验室各月的HBsAg ELISA每种试剂需进行重复检测标本数量(IR)和ELISA重复检测为反应性标本数量(RR)2个指标,在各实验室间进行比较分析。结果1)2018年北京、天津、河北地区15家血站实验室HBsAg ELISA的复检率和复检符合率差异均有统计学意义(P<0.01);2)6种HBsAg ELISA试剂的复检符合率差异有统计学意义(P<0.01);3)R1~R44种试剂在不同实验室间的复检符合率差异均有统计学意义(P<0.05);4)E、I、J、M 4个实验室内不同试剂间的HBsAg复检符合率差异均无统计学意义(P>0.05),其余各实验室内不同试剂间的HBsAg复检符合率差异均有统计学意义(P<0.05);5)不同规模实验室的HBsAg复检符合率差异有统计学意义(P<0.01),结果为"中规模、小规模>大规模"。结论2018年北京、天津、河北地区15家血站实验室HBsAg ELISA复检符合率差异较大,除使用试剂本身的差异外,实验室的其他因素对HBsAg复检符合率也有较大影响,各实验室在HBsAg检测中存在的问题及改进方法有待进一步研究和探讨。Objective To analyze the concordance rate of HBsAg ELISA retest results and inital reactive results in the blood station laboratories in Beijing-Tianjin-Hebei region in 2018,and explore the differences in HBsAg detection ability and the influencing factors,so as to lay the foundation for the homogenization of the blood station laboratories in the Beijing-Tianjin-Hebei region.Methods The monthly number of each reagent initial reactive(IR)and repeated reactive(RR)in HBsAg ELISA of 15 blood station laboratories in Beijing-Tianjin-Hebei region in 2018 were collected via questionnaires,and the differences among laboratories were compared and analyzed.Results 1)Both of the retest rate and the concordance rate of RR/IR in HBsAg ELISA of 15 blood station laboratories in the Beijing-Tianjin-Hebei region in 2018 showed statistically significant differences(P<0.01);2)The RR/IR rates of 6 kinds of HBsAg ELISA reagents had statistically significant differences(P<0.01);3)The RR/IR rates of HBsAg in four reagents(R1~R4)among different laboratories had statistically significant differences(P<0.05);4)The RR/IR rates of HBsAg in four laboratories(E,I,J and M)using different reagents had no statistically significant difference(P>0.05),while the RR/IR rates among different reagents in other 11 laboratories had statistically significant differences(P<0.05);5)The RR/IR rates of HBsAg in laboratories with different sizes had a statistically significant difference(P<0.01),and the RR/IR rates in medium/small laboratories was higher than that of large ones.Conclusion The RR/IR rate of HBsAg ELISA retest in 15 blood station laboratories in the Beijing-Tianjin-Hebei region in 2018 was quite different from each other.In addition to the differences lying in reagents themselves,other factors in the laboratories also had a great impact on the RR/IR rate.The existing problems and strategies for future improvement in HBsAg detection of each laboratory need to be further studied and discussed.

关 键 词：京津冀地区 血站实验室 HBSAG ELISA 复检符合率 

分 类 号：R457.1[医药卫生—治疗学] R512.62[医药卫生—临床医学]