摘要
目的针对京津冀血站血液筛查实验室(简称血站实验室)所使用检测试剂进行调查。探讨各实验室在试剂使用方面的差别及对血液检测过程的潜在影响。为进一步分析各实验室检测质量和实现血液检测质量管理同质化提供依据。方法设计特定问卷调查表,向区域内血站发放。调查内容包括各实验室检测试剂种类、质控品使用情况、试剂年使用批次等。整理数据进行分析。结果血型试剂方面,京津冀15家血站实验室中仅有2家使用进口血型检测试剂,其余均使用国产试剂,上海血液、Immucor、北京金豪试剂检测量占比达到89%;12家实验室采用自行制备血型质控品,3家实验室选择购买商品化的血型质控品,保证RhD(-)自制质控品有一定难度;ELISA试剂方面,国产试剂检测量占80.6%,进口试剂占19.4%,集中在万泰、丽珠、科华和新创4家;存在相同ELISA试剂采用不同浓度质控品情况,使用相同试剂和质控值S/CO值存在明显差异。ELISA试剂年订货批次各家实验室有统计学差异。NAT检测试剂以Grifols试剂、华益美试剂和科华NAT试剂为主,区域内Grifols试剂检测量占38.2%,华益美试剂检测量占25%,科华NAT试剂检测量占23.4%。结论区域内血型试剂和ELISA试剂以应用国产试剂为主;血型质控品以自制为主,ELISA质控品全部采用商品化质控品,应对质控品S/CO值存在较大差异进行分析;区域内NAT检测试剂相对集中,NAT检测外部质控品尚没有统一的应用浓度;应规范试剂订货批次,减少试剂质量抽检次数,提高实验室突发事件应对能力。京津冀血站实验室需分析差异对血液检测质量的影响,消除或减小差异,推进区域血站实验室的同质化建设。
Objective This study is aim to investigate the reagent application status in the laboratories of the blood banks in Beijing,Tianjin and Hebei. To implore the differences in reagent usage among laboratories and predict potential effects on the blood testing process,laying a foundation for the analysis of the testing quality and the homogenization of quality management. Methods The pre-designed questionnaires were sent to the blood banks in the region. Information regarding laboratory test reagents,quality control products,and usage amount were collected and analyzed. Results For the blood type detection reagent,only 2 laboratories used imported reagents,and the rest used domestic reagents. The Shanghai Blood,Immucor and Beijing Kinghawk Reagents account for 89% of the reagent selected; 12 laboratories used self-determined quality control systems while 3 laboratories chose to purchase commercial quality control products,which appeared to present certain difficulties in ensuring Rh D(-) self-made control samples. Domestic reagents and imported reagents accounted for80. 6% and 19. 4% respectively in the ELISA reagent usage,which included on Wantai,Livzon,Kehua and Xinchuang. Some blood banks use the same ELISA reagents but the concentrations of control samples were different,and the differences in the S/CO values were significant in the laboratories with the same reagent type and quality control systems; There was significant differences in the ELISA reagent annual order batches among laboratories. For the NAT detection,Grifols reagent,Hua Yi mei reagent and KELONG NAT reagent were the dominant types.The detection volume by Grifols reagents accounted for 38. 2%,the Hua Yi mei for 25%,KELONG reagent for 23. 4% in the three regions,respectively. Conclusion The domestic blood type reagents and domestic ELISA reagents were both applied.The quality control for blood type detection is mainly tested by self-made control samples,and the quality control of ELISA products is mainly tested by commercialized quality control prod
作者
王艳彬
韩卫
张慧贤
黄力勤
葛红卫
王瑞
潘彤
王鹏
杨莉
孙绍秋
曹晓
崔立晔
魏超
于桂军
徐云鹏
房金娟
刘彩侠
王学刚
甄志军
刘晓杰
杜文功
王露楠
戚海
王鸿捷
LI Chunfang
WANG Yanbin;HAN Wei;ZHANG Huixian;HUANG Liqin;GE Hongwei;WANG Rui;PAN Tong;WANG Peng;YANGLi;SUN Shaoqiu;CAO Xiao;CUI Liye;WEI Chao;YU Guijun;XU Yunpeng;FANG Jinjuan;LIU Caixia;WANG Xue-gang;ZHEN Zhijun;LIU Xiaojie;LI Chunfang;QI Hai;WANG Hongjie(Hebei Blood Center;Beijing RedCross Blood Center;Tianjin Blood Center;Beijing Tongzhou Central Blood Station;Tanggu District Blood Station;Tangshan Central Blood Station;Baoding Central Blood Station;Cangzhou Central Blood Station;Zhangjiakou Central Blood Station;Hengshui Central Blood Station;Chengde Central Blood Station;Handan Central Blood Station;Xingtai Central Blood Station;Qinhuangdao Central Blood Station;Langfang Central Blood Station;National Center for Clinical Laboratories)
出处
《中国输血杂志》
CAS
2018年第10期1114-1118,共5页
Chinese Journal of Blood Transfusion
基金
中国输血协会团体标准制定项目:《血站血液检测实验室质量监测指标》P2018-004
关键词
京津冀
血站实验室
试剂
质控品
年订货批次
质量抽检
突发事件
Beijing-Tianjin-Hebeii
Blood Bank Laboratory
reagents
quality control
annual order batch
qualitysampling inspection
emergency
