贝克曼AU5800全自动生化分析仪检测血浆脂蛋白磷脂酶A2的性能验证  

Verification of the performance of Backman AU5800 automatic biochemistry analyzer for the detection of plasma lipoprotein phospholipase A2

作　　者：兰庆站 成士清[1] 刘义庆[1] 路超[1] 高琦[1] 郑妮[1] 潘翠翠[1] LAN Qingzhan;CHENG Shiqing;LIU Yi qing;LU Chao;GAO Qi;ZHENG Ni;PAN Cuicui(Department of Clinical Laboratory,Shandong Provincial Hospital Affiliated to Shandong University,Jinan,Shandong 250014,China)

机构地区：[1]山东大学附属省立医院临床医学检验部,山东济南250014

出　　处：《国际检验医学杂志》2018年第18期2249-2252,共4页International Journal of Laboratory Medicine

基　　金：山东省自然科学基金资助项目(ZR2016HM52);山东省临床重点专科建设项目经费资助(鲁卫医字[2013]26号)

摘　　要：目的验证贝克曼AU5800全自动生化分析仪速率法检测血浆脂蛋白磷脂酶A2(Lp-PLA2)的分析性能。方法参考美国临床和实验室标准化协会(NCCLS)系列文件和相关文献设计验证方案,对贝克曼AU5800全自动生化分析仪速率法检测Lp-PLA2精密度、准确度、分析线性范围、生物参考区间和携带污染率等进行验证及评价。结果该方法的批内和批间精密度决定系数(CV)值分别为1.39%~2.67%和3.00%~3.47%,均小于规定的范围,准确度验证达到相关文件要求,线性范围在9.63~1 580.87IU/L内良好(验证回归系数a值在0.97~1.03,r^2=0.999 6),生物参考区间及携带污染率均符合要求。结论贝克曼AU5800全自动生化分析仪速率法检测Lp-PLA2分析性能符合临床要求,测定结果灵敏度高,稳定性好,检测范围宽,具有良好的准确性和重复性,适合应用于临床。Objective To verify the analytical performance of plasma lipoprotein phospholipase A2 （Lp-PLA2） by Backman AU5800 automatic biochemical analyzer. Methods With reference to the NCCLS series and related literature design verification scheme,the Lp-PLA2 precision,accuracy,linear range,biological reference range and carrying pollution rate were tested and evaluated by the rate method of Backman AU5800 automatic biochemical analyzer. Results The internal and inter batch precision determination coefficient （ CV ） values of the method wer 1.39%-2.67% and 3.00%-3.47% respectively,both were less than the specified range,the accuracy was verified to meet the requirements of the relevant documents,and the linear range was good within 9.63-1 580.87 IU/L （the a value of regression coefficient was 0.97-1.03, r 2=0.999 6）,the biological reference interval and the carrying capacity were carried out.The pollution rate was in accordance with the requirements. Conclusion Backman AU5800 automatic biochemical analyzer rate method for the detection of Lp-PLA2 analysis performance meets the clinical requirements.The results have high sensitivity,good stability,wide detection range,good accuracy and repeatability.It is suitable for clinical application.

关 键 词：全自动生化分析仪 精密度 准确度 线性范围 性能验证 

分 类 号：R446.6[医药卫生—诊断学]