质控图联合Westgard多规则法评价两套生化检测系统测定尿酸的室内质控方案  

The Evaluation of Internal Quality Control Plan for Uric Acid Determination by Two Sets of Biochemical Detection Systems Using Quality Control Charts Combined with Westgard Multi-rule Method

作　　者：严诗云 吴静标[1] 韩芝斌 姚燕丽[1] 曹春玲 黄燕虹[1] Yan Shiyun;Wu Jingbiao;Han Zhibin;Yao Yanli;Cao Chunling;Huang Yanhong(Guangdong Medical Devices Quality Surveillance and Test Institute,Guangzhou Guangdong 510663,China)

机构地区：[1]广东省医疗器械质量监督检验所,广东广州510663

出　　处：《医疗装备》2023年第16期23-26,共4页Medical Equipment

基　　金：广东省重点领域研发计划项目(2020B1111160001)。

摘　　要：目的 联合应用质控图和Westgard多规则法,对所建立的2套生化检测系统测定尿酸的室内质控方案及结果进行评价。方法 使用2套生化检测系统对人基质定值生化质控血清水平2、水平3进行连续20 d的精密度和准确度检测,统计人基质定值生化质控血清水平2、水平3实测值与靶值的相对偏差,比较2套检测系统的精密度结果的差异,分别绘制Levey-Jennings质控图和Z-分数质控图,联合Westgard多规则法评价2套生化检测系统测定尿酸的室内质控方案及结果。结果 人基质定值生化质控血清水平2、水平3在2套生化检测系统的精密度和准确度结果均符合行业标准YY/T 1207-2013要求;日立7180生化分析仪检测水平2提示警告1次,水平3均合格,AU680生化分析仪检测水平2提示警告1次,水平3提示警告1次、失控1次。结论 Westgard多规则法和质控图联合应用进行室内质量控制,可有效提高生化检测项目性能,对检验质量的持续改进具有重要指导意义。Objective The internal quality control plan and results of the two established biochemical detection systems for measuring uric acid were evaluated by combining quality control chart and Westgard multi-rule method.Methods With 20 consecutive days of precision and accuracy testing for Human matrix calibration biochemical quality control serum with levels 2 and 3 produced using two sets of biochemical detection systems,the relative deviation between the measured values of serum levels 2 and 3 of human matrix biochemical quality control and the target values was statistically analyzed,and the difference in precision results between the two detection systems was compared.In addition,Levey-Jennings quality control charts and Z-score quality control charts were drawn separately,and the internal quality control plans and results of two biochemical detection systems for measuring uric acid were evaluated using the combined Westgard multi-rule method.Results The precision and accuracy results of human matrix fixed value biochemical quality control serum with levels 2 and 3 in two sets of biochemical detection systems met the industry standard requirements of YY/T 1207-2013;The Hitachi 7180 biochemical analyzer detected level 2 with one warning,and level 3 was qualified.The AU680 biochemical analyzer detects level 2 with one warning,level 3 with one warning,and out of control once.Conclusion The combined application of Westgard multi-rule method and quality control chart for internal quality control can effectively improve the performance of biochemical testing projects,and has important guiding significance for the continuous improvement of detection quality.

关 键 词：质控图 Westgard多规则法 尿酸 质控 生化分析 

分 类 号：R446.11[医药卫生—诊断学]