蔡跃苏^1，2，， 蔡彤彤^3，， 万建新^1，， 詹日明^2，， 刘敏^1，， 李来胜^1，*

（  1、中山大学附属第一医院检验医学部，广州 510080；       2、广东医科大学医学检验学院，东莞 523000；       3、汕头中心医院中山大学附属汕头医院神经内科，汕头，515031；  ）

摘要： 摘要:目的 通过对比与评价环孢素A( cyclosporine A ,CsA) 在ARCHITECT i2000和西门子Viva-E两种不同型号仪器检测系统测定结果的差异，寻找合适医院开展CsA项目检测的仪器。方法 参照美国临床实验室标准化委员会(NCCLS) 的EP9-A2和EP5-A2文件要求,采用ARCHITECT i2000的化学发光微粒子免疫检测法(CMIA)和西门子Viva-E的酶放大免疫测定法(EMIT)测定CsA，以ARCHITECT i2000的CMIA为参比方法，西门子Viva-E的EMIT为实验方法，将两种方法测量结果利用统计学软件进行比对和偏倚评估。结果 通过绘制散点图，未发现离群点；两种检测系统测定CsA结果显著相关，两种检测系统测定CsA项目的精密度评价以及测定患者CsA结果的偏倚均为临床可接受范围。结论 ARCHITECT i2000和西门子Viva-E两种检测系统检测CsA结果具有可比性，临床可根据需要选择合适的检测系统测定CsA。
关键词： CsA；比对；ARCHITECT i2000 ；西门子Viva-E；结果

Cai Yuesu^1,， Cai Tongtong^2,， Wan Jianxin^3,， Zhan Riming^1,， Liu Min^2,， Li Laisheng^1,*

（  1、Department of Laboratory Medicine,The First Affiliated Hospital of Sun Yat-Sen University,Guangzhou,510080；       2、Institute of Laboratory Medicine,Guangdong Medical University,Dongguan,523000；       3、Department of Neurology,The Affiliated Shantou Hospital of Sun Yat-Sen University,Shantou,515031；  ）

Abstract： Objective: By comparison and evaluation the results of CsA in ARCHITECT i2000 and SIEMENS Viva-E two different types of instrument testing system, finding the appropriate instrument for the hospital to detect CsA. Methods: Using ARCHITECT i2000 CMIA and SIEMENS Viva-E EMIT to detect CSA, with reference to the National Committee for Clinical Laboratory Standards (NCCLS) EP9-A2 and EP5-A documentation requirements. The study compare two different methods of the result of CsA and evaluate their biases by analysis in ARCHITECT i2000 as a control method and SIEMENS Viva-E as a experimental method. Results: In the study, there are no abnormal values were found in the scatter plots and the results of two analysis systems correlated significantly. The evaluation of precision and the biases can be accepted by clinical. Conclusion: The test results of ARCHITECT i2000 CMIA and SIEMENS Viva-E EMIT showed the good comparability, and clinical can choose the appropriate analysis systems to test CsA. )
Keywords： CsA; comparative study; ARCHITECT i2000; SIEMENS Viva-E; result

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