2019 年第 8 期 第 14 卷

全自动化学发光仪检测血清脂蛋白相关磷脂酶A2的性能评价

Performance evaluation of automatic chemiluminescence analyzer in detecting serum lipoprotein-associated phospholipase A2

作者：王晓伟辛晓文王晓燕周珊李宁姚继承

英文作者：

单位：264209威海威高生物科技有限公司研发中心（王晓伟、李宁、姚继承）；264200山东省威海市立医院临床检验科（辛晓文、周珊）；264200山东省威海市传染病医院检验科（王晓燕）

英文单位：

关键词：全自动化学发光仪；精密度；准确度；线性范围；性能验证

英文关键词：

• 摘要：

• 【摘要】目的    验证全自动化学发光仪检测血清脂蛋白相关磷脂酶A2（Lp-PLA2）的性能。方法    参考美国临床和实验室标准化协会颁布的系列文件和《医疗机构临床实验室管理办法》相关文献设计验证方案，对AutolumiS3000全自动化学发光仪检测Lp-PLA2的精密度、可报告检测范围、准确度、参考区间进行验证评价。结果    全自动化学发光仪检测Lp-PLA2的批内精密度变异系数为3.45%～3.82%，批间精密度变异系数为3.90%～4.39%，均小于说明书中声明的10%，通过验证。根据可报告检测范围验证结果计算得线性方程为Y=0.987X-29.012，相关系数r2=0.995 7，结果显示在厂家声明的0.1～1 000.0 μg/L范围内线性相关良好，验证通过。准确度验证结果显示检测后实测平均值均落在理论浓度±10%允许偏差范围内；测试均值计算线性方程为Y=0.975X+16.365，相关系数r2=0.989 8；在新鲜血清中分别加入20、50、100 μl的本验证质控品，进行回收试验，对质控品的回收率分别为98.3%、101.2%和108.6%，均在规定范围内，准确度验证通过。本研究纳入的200份健康体检者血清验证结果最低值为58.1 μg/L，最高值为191.0 μg/L，都在厂商提供的41.24～199.28 μg/L参考区间之内，也符合相关法规要求，说明该参考区间适用于本实验室。结论    AutolumiS3000全自动化学发光仪检测Lp-PLA2的主要性能与厂家提供的资料和要求基本一致，且符合相关标准，可以满足临床应用。

• 【Abstract】Objective    To verify the performance of automatic chemiluminescence analyzer in the detection serum lipoprotein-associated phospholipase A2（Lp-PLA2）. Methods    With reference to the National Committee for Clinical Laboratory Standards series, literatures design and validation schemes of Management Measures of Clinical Laboratories in Medical Institutions, the precision, accuracy, linear range and biological reference of serum Lp-PLA2 detected by AutolumiS3000 automatic chemiluminescence analyzer were analyzed. Results    Coefficients of variation of intra-batch and inter-batch precision were 3.45%-3.82% and 3.90%-4.39%, respectively, which were less than the specified range(10%). The linear equation was Y=0.987X-29.012 and the correlation coefficient was r2=0.995 7; the linear correlation was good in the range of 0.1-1 000 μg/L declared by the manufacturer. The mean values of tested samples were within the allowable deviation range of theoretical concentration(±10%); the linear equation for calculating the mean values was Y=0.975X+16.365 and the correlation coefficient was r2=0.989 8; the recovery rates of quality control products(20, 50 and 100 ml) were 98.3%, 101.2% and 108.6%, respectively, suggesting reasonable accuracy in detecting Lp-PLA2. The lowest and highest validation results in 200 health examinees were 58.1 μg/L and 191.0 μg/L, which were within the reference range of 41.24-199.28 μg/L provided by the manufacturer and met the requirements of relevant laws and regulations, indicating that the reference range was suitable for our laboratory. Conclusion    AutolumiS3000 automatic chemiluminescence analyzer meets the instructions from manufacturer and clinical requirements and criterion in detecting of Lp-PLA2.