罗氏Cobas 6000全自动电化学发光分析仪检测AFP，CEA的性能验证

Performance Verification of the Detection of AFP and CEA in Roche Cobas 6 0 0 0 Automatic Electrochemical Luminescence Analyzer

目的：对罗氏Cobas 6000全自动电化学发光检测系统检测甲胎蛋白（AFP）和癌胚抗原（CEA）进行性能验证。方法收集2014年1～4月期间医院住院患者血清样本，混合成不同水平的混合血清，参照 CLSI EP文件及其它文献，验证罗氏Cobas 6000全自动电化学发光检测系统检测 AFP和CEA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 AFP 和 CEA两个项目的低、高值质控物批间精密度的变异系数（CV）分别为 AFP （6.53％，8.38％），CEA（8.15％，7.84％），批内精密度的变异系数（CV）分别为 AFP（3.97％，6.51％），CEA（4.77％，4.52％）。测定10份定值室间质评物的检测结果与“靶值”的最大偏倚分别为AFP（－12.62％），CEA（－10.71％），均在偏倚允许范围之内。验证实验的分析测量范围为 AFP（0.5～1000 IU／ml），CEA（0.2～1000 ng／ml），临床可报告范围为AFP（0.5～1000 IU／ml），CEA（0.2～1000 ng／ml）。结论罗氏Cobas 6000全自动电化学发光免疫分析系统检测 AFP， CEA性能良好，能够满足临床检测的性能要求。

Objective To evaluate the performance verification of AFP and CEA detected by Roche Cobas 6000 automatic electrochemical luminescence analyzer.Methods Serum samples in hospital patients during April 1 to 4,2014 were collected and mixed.Samples with the different levels of AFP and CEA were prepared.Referring to CLSI EP files and other docu-ments,the precision,accuracy and the reported linear range of AFP and CEA from Roche Cobas 6000 automatic electrochem-ical luminescence analyzer were verified.Results AFP and CEA in the quality control sera with low and high values were detected by Roche Cobas 6000 automatic electrochemical luminescence analyzer.The coefficient of variations （CV）of inter batch precision were AFP （6.53%,8.38%）,CEA （8.15%,7.84%）,and the CV of within batch precision were AFP （3.97%,6.51%）,CEA （4.77%,4.52%）,respectively.10 copies of laboratory quality control were analyzed,issued by the National Center for clinical laboratory in 2013.The largest bias between detection results and“target value”were AFP （-12.62%）and CEA （-10.71%）respectively,which were all within the measurement range of quality assessment.Analysis of measuring range in the linear range experiment were AFP （0.5～1 000 IU/ml）,CEA （0.2～1 000 ng/ml）,and the clini-cal reportable range were AFP （0.5～1 000 IU/ml）,CEA （0.2～1 000 ng/ml）,respectively.Conclusion Detection of AFP and CEA from Roche Cobas 6000 automatic electrochemical luminescence analyzer had a good performance.Meanwhile,the Roche Cobas 6000 automatic electrochemical luminescence analyzer could meet the clinical routine testing requirements.