摘要
目的通过调查京津冀地区15家血站血液筛查实验室(简称血站实验室)的ELISA室内质量控制(简称室内质控)策略,了解实验室过程稳定性监控模式的具体方式,甄别实验室间质控策略的差异,推进京津冀地区血站实验室同质化建设。方法通过调查表分别收集各血站实验室ELISA室内质控信息,包括质控物种类及浓度、控制频次、控制方法(构图方法、质控规则)、控制方式及质控数据分析情况。结果1)质控物种类及浓度:京津冀15家血站实验室均采用商品化的弱阳性质控品进行ELISA室内质控活动,但部分实验室无法达到S/CO值为2—5的技术要求;外部阴性质控品呈现多样性,其中6家实验室为商品化阴性质控品、3家实验室为自制阴性质控品、6家实验室未采用阴性质控品。2)控制频次:京津冀15家血站实验室在ELISA试验中均采用统一的质控批长度,即每一块酶标板作为一个质控批次。3)控制方法:15家实验室均采用SPC技术对数据进行分析和监控。采用外部阴性质控品的9家实验室均将其纳入结果有效性判定。15家实验室均使用外部弱阳性质控品绘制Levey-Jennings图(简称L-J图),但建立L-J图质控框架方法呈现多样性,其中2家实验室采用预实验、11家实验室采用即刻法、2家实验室采用数据累积法的方式。有5家血站实验室同时利用X-Bar图监控系统误差和趋势变化。15家实验室至少采用2种质控规则监控随机误差和系统误差,违反质控规则时各实验室的处理策略呈现多样性。4)控制方式:15家实验室均在信息系统中设有独立的室内质控模块,实现对质控数据的自动判定及强行控制。5)质控数据分析情况:15家实验室均使用质控小组的模式对质控数据进行分析和处理,7家实验室支持对质控数据进行拓展性分析。结论京津冀15家血站实验室均在信息系统平台上进行了有效的室内质控活动,但各实验室在ELISA室内质控策略上存在一定差异,部分实验室仍有优化及改进的空间。应依据各个实验室的实际情况和检测能力,选择适宜的质控品、使用适宜的质控方法,确保室内质控对试验稳定性和有效性的监控效果。
Objective Investing the IQC strategy of ELISA of in Beijing-Tianjin-Hebei blood screening laboratories,to improve the testing quality and lay the foundation of testing quality unification program of these laboratories. Methods Using questionnaire to collect data from the laboratories in Beijing-Tianjin-Hebei Region,including quality control materials and concentration,frequency,method,mode and data analysis,which can reflect the quality control strategy. Results 1) Type of quality control materials. All 15 laboratories use commercial positive quality control to carry out IQC,and apply SPC technology to analyze and monitor the data. However,some laboratories can’t meet the technical requirement with SCO value of2—5 in practical application. It shows diversity on the external negative quality control. 6 laboratories use commercial negative quality control,3 laboratories use self-made negative quality control,and 6 laboratories don’t use negative quality control. 2)The control frequency is unanimous requirement in All 15 laboratories,which is each block of the enzyme as a quality control batch. 3) The result of external negative quality control is used as the test validity standard in 9 laboratories. The result of external positive quality control is used to draw the Levey-Jennings chart( L-J chart). Pre-experiment method is applied to establish the framework of quality control chart in 2 laboratories,Grubbs method and data accumulation method is applied to establish the framework of quality control chart in 11 and 2 laboratories,respectively. Moreover,5 laboratories simultaneously draw X-Bar chart to monitor the stability of the test. At least 2 kinds of quality control rules are used in 15 laboratories to monitor the random error and system error. When the quality control rules are violated,the treatment strategies of each laboratory are diversified.4) There are independent IQC modules in the laboratory information system in all 15 laboratories to achieve automatic judgement and forced control. 5) The quality control data are analyzed and processed by the quality control group in 15 laboratories,and 7 laboratories supported the expansibility analysis of quality control data. Conclusion The blood screening laboratories in Beijing-Tianjin-Hebei region have carried out effective IQC activities on the information system platform,but there are certain differences in the quality control strategies in ELISA,and some laboratories still have the space for optimization and improvement. According to the ability of each laboratory,the appropriate quality control materials should be selected and the appropriate quality control method should be applied in order to ensure the monitoring effect.
作者
王瑞
葛红卫
黄力勤
潘彤
韩卫
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
王鸿捷
刘江
WANGRui;GE Hongwei;HUANG Liqin;PAN Tong;HAN Wei;WANG Peng;YANG Li;SUN Shaoqiu;CAO Xiao;CUILiye;WEI Chao;YU Guijun;XU Yunpeng;FANG Jinjuan;LIU Caixia;WANG Xuegang;ZHEN Zhijun;LIU Xi-aojie;DU Wengong;WANG Lunan;WANG Hongjie;LIU Jiang(Beijing Red Cross Blood Center,Beijing 100088 China;Tianjing Blood Center;Hebei Blood Center;Tongzhou Blood Bank;Tanggu Blood Bank;TangshanBlood 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 BloodBank;National Center for Clinical Laboratories)
出处
《中国输血杂志》
CAS
2018年第10期1119-1124,共6页
Chinese Journal of Blood Transfusion
关键词
酶联免疫吸附试验
室内质量控制
血站实验室
京津冀地区
enzyme linked immunosorbent assay ( ELISA)
internal quality control (IQC)
blood screening laboratory
Beijing-Tianjin-Hebei Region
作者简介
并列通信作者:王鸿捷(1966.1-),男,主任技师,主要从事血站业务及质量管理研究,电话:010-82807250,Email:hjgewang@163.com;并列通信作者:刘江(1961.12-),男,主任技师,主要从事血站业务及质量管理研究,电话:010-82807766,Email:public@brcbc.sina.net
