罗氏Cobas6000全自动电化学发光分析仪FPSA和TPSA的性能验证.PDFVIP

罗氏Cobas 6000全自动电化学发光分析仪FPSA和TPSA的性能验证 解放军302医院临床检验医学中心 李想 摘 要：目的 对罗氏Cobas 6000全自动电化学发光检测系统检测 FPSA和TPSA进行性能验证评价。方法 收集2014年1-4月期间医院 门诊、住院患者和正常健康体检者的血清样本，混合成正常水平和异 常水平的混合新鲜血清，参照CLSI EP文件及其他文献，验证罗氏 Cobas 6000全自动电化学发光检测系统检测FPSA和TPSA 的精密度、 准确度和可报告范围。。结果 罗氏Cobas 6000全自动电化学发光免疫分析 仪检测FPSA和TPSA 7个项目的低、高值质控血清批间精密度的变异系数（CV ） 分别为FPSA （7.29 ，8.75 ％）、TPSA （7.03 ，6.19 ％）。测定10份卫生部临检中 心20 13年发放的室间质控品的检测结果与 “靶值”的最大偏倚分别为FPSA （5.66 ％）、TPSA （7.778 ％），均在质评的测量范围之内。线性范围验证实验 的分析测量范围为FPSA （0.01~50 ）、TPSA （0.03~ 100），临床可报告范围为FPSA （0.01~47 ）、TPSA （0.03~97 ）。 结论 罗氏Cobas 6000全自动电化学发光免疫 分析系统检测FPSA和TPSA性能良好，能够满足检测的性能要求。 关键词：全自动电化学发光分析仪；肿瘤标志物；性能评价 Performance verification methodology of Roche Cobas 6000 automatic electrochemiluminescence analyzer for detection of seven tumor markers Abstract: Objective To verify the performance evaluation of Roche Cobas 6000 automatic electrochemiluminescence analyzer detection system for detection of FPSA and TPSA. Methods We detected and verified the performance index (reportable range linear relationship, precision, accuracy) of FPSA and TPSA by Roche Cobas 6000. Results The a and r2 of reportable range linear relationship of FPSA and TPSA respectively were FPSA (0.9827, 0.9913), TPSA (0.9726, 0.9896), which were detected by Roche Cobas 6000 automatic electrochemiluminescence immunoassay analyzer. Meanwhile, the coefficient of variation (CV) of intra batch precision FPSA (5.02, 6.56 ％), TPSA (4.13, 4.30 ％), inter batch precision were FPSA (7.29, 8.75 ％), TPSA (7.03, 6.19 ％), respectively. What’s more, the detection results and the bias of “targetvalue” from the 10 room control respectively were FPSA (5.66 ％), TPSA (7.778 ％), which were all in the range of external quality assessment (EQA). Conclusion The system detection performan