全自动生化分析仪检测胆固醇指标性能验证  

Performance verification of automatic biochemical analyzer on detection of serum cholesterol

作　　者：张娟[1] 滕新栋 徐翮飞[1] 张瑾[1] 陈晓光[1] 徐颖[1] 张齐[1] ZHANG Juan;TENG Xin-dong;XU He-fei;ZHANG Jin;CHEN Xiao-guang;XU Ying;ZHANG Qi(Shandong International Travel Healthcare Center,Qingdao,Shandong 266071,China)

机构地区：[1]山东国际旅行卫生保健中心,山东青岛266071

出　　处：《中国国境卫生检疫杂志》2018年第5期317-320,共4页Chinese Journal of Frontier Health and Quarantine

基　　金：国家质检总局科技计划项目(2015IK206;2017IK115);山东出入境检验检疫局科技计划项目(SK201720)

摘　　要：目的对贝克曼AU680全自动生化分析仪的胆固醇指标(总胆固醇TC、甘油三酯TG、高密度脂蛋白胆固醇HDLC和低密度脂蛋白胆固醇LDL-C)检测进行性能验证,确保检测结果的准确可靠。方法根据我国卫生行业标准及美国临床实验室标准化协会相关文件,从精密度、正确度、检测结果可报告范围和生物参考区间4个方面进行验证。结果贝克曼AU680全自动生化分析仪检测TC、TG、HDL-C和LDL-C低值的实验室变异系数分别为0.79%、1.05%、0.94%、2.53%,批间差分别为2.40%、3.00%、3.60%、9.10%:4个项目高值血清的实验室变异系数分别为1.08%、1.69%、1.86%、2.61%;批间差分别为2.70%、3.80%、6.00%、8.50%,均在厂家声称的范围内,精密度验证通过。TG和HDL-C低值的定值未落在置信区间内,其余各指标均包含在其中;重新计算TG和HDL-C低值的定值验证区间后,包含了参考物质的定值,正确度验证通过。4项指标的r^2>0.995,说明线性范围验证通过。4项指标检测范围分别为3.12~5.81、0.58~1.71、1.15~2.19和1.87~3.01 mmol/L,均位于厂家声明的生物参考区间。结论贝克曼AU680全自动生化分析仪检测胆固醇4项指标满足各项验证要求,通过性能验证。Objective To evaluate the performance feature of Beckman AU680 automatic biochemical analyzer on de-tection of serum cholesterol（TC,TG,HDL-C and LDL-C）.Methods Based on the evaluation protocol documents from health industry standard of the People＇s Republic of China and Clinical and Laboratory Standards Institute（CLSI）,verification of performance was performed in four aspects,including precision,trueness,reportable range and reference interval.Results The coefficient of variation（CV） of TC,TG,HDL-C and LDL-C on low value serum was0.79%,1.05%,0.94%,2.53%,and the inter assay variations was 2.40%,3.00%,3.60%,9.10%,respectively.The CV of the 4 indictors on high value serum was 1.08%,1.69%,1.86%,2.61% and the inter assay variations was 2.70%,3.80%,6.00% and 8.50%,respectively.All of them were covered in CVs and inter assay variations stated by the manufacturer.The verification of performance for precision of TC,TG,HDL-C and LDL-C was acceptable.Confidence interval was covered the results of all indicator except low value of TG and HDL-C,which were covered after being recalculated,and verification of performance for trueness was acceptable.Reportable range indicated that r^20.995,which illustrated that the method was linear in experiment concentration range.Reference intervals of TC,TG,HDL-C and LDL-C were 3.12-5.81,0.58-1.71,1.15-2.19 and 1.87-3.01 mmol/L,respectively.All of them were covered in reference intervals stated by the manufacturer.Conclusion Performance verification of Beckman AU680 automatic biochemical analyzer on detection of serum cholesterol verified the equipment executed correctly and met detection requirements,and it could be suitable for clinical detection.

关 键 词：生化 胆固醇 验证 

分 类 号：R446.112[医药卫生—诊断学]