电化学发光肿瘤标志物检测质控计划建立方法的探讨  

A Discussion on the Establishment of Quality Control Plan forElectrochemical Luminescent Tumor Marker Detection

作　　者：梁河涛[1] 刘华伟[1] 黄潇苇[1] 叶庭菠 LIANG Hetao;LIU Huawei;HUANG Xiaowei;YE Tingbo(Department of Clinical Medical Laboratory,The Third People′s Hospital of Chengdu,Chengdu 610031,China)

机构地区：[1]成都市第三人民医院临床医学检验部,成都610031

出　　处：《标记免疫分析与临床》2020年第12期2181-2185,共5页Labeled Immunoassays and Clinical Medicine

基　　金：成都市卫计委课题“CNTN3蛋白在胃癌中的表达与疾病预后的相关性分析”(编号:2018069)。

摘　　要：目的探讨电化学发光肿瘤标志物检测建立新的质控计划时,采用厂家给定的目标值作为室内质控暂定均值的可行性研究。方法收集2017年至2019年近三年间的室内质控数据和卫生部室间质评结果并计算相应项目的σ值。将5组批号质控品前20个点累计结果均值和相应批号使用期间全部累计结果均值,分别与厂家给定目标值进行比较,计算相关系数(R 2)与差异分析。结果质控品的目标值与20个点累计均值和全部结果累计均值相比,差异无统计学意义;采用质控品的目标值作为室内质控计划均值期间,室间质评结果良好,2017至2019三年间,各项目σ值均达到4以上,超出实验室质量目标要求,获得良好的性能评价。结论考虑到成本、效率以及长时间内可变因素较多等情况,在建立新的电化学发光肿瘤标志物检测的室内质控计划时,采用厂家的质控品目标值作为质控计划的暂定均值,该法简便可行。Objective To explore the feasibility of using the target value provided by the manufacturer as the quality control target value when to establish a new quality control plan for the detection of electrochemiluminescent tumor markers.Methods We collected the internal quality control data from 2017 to 2019 and the results of the external quality assessment of the Ministry of Health and theσvalue of the corresponding items,then compared with the target value provided by the manufacturer,and calculated the correlation coefficient(R 2)to evaluate the difference.Results There was no statistically significant difference between the quality control target value provided by the manufacturer and the cumulative value of the first 20 points and the total value of all results.During the period when the target value provided by the manufacturer was used as the target value of the quality control plan,the external quality evaluation results were good in the three years of duration from 2017 to 2019,in which each item′sσvalue reached 4 or more,exceeding the laboratory quality target requirements,and we obtained an excellent evaluation.Conclusion Considering the cost,efficiency,and many other contributing factors over a long period of time,when establishing a new quality control plan for the detection of electrochemiluminescent tumor markers,the target value provided by the manufacturer can be considered as the tentative target of the quality control plan value.

关 键 词：质量控制计划 暂定均值 电化学发光技术 肿瘤标志物 

分 类 号：R-331[医药卫生]