血清甲胎蛋白在两个免疫分析系统间检测的比对评估  

The Evaluation of the Outcome Bias of AFP between Two Different Imunity Analysis Systerm

作　　者：蔡新[1] 余清[1] 杨丽[1] 梁鑫[1] 

机构地区：[1]江苏省中医院检验科,南京210029

出　　处：《数理医药学杂志》2008年第2期169-173,共5页Journal of Mathematical Medicine

摘　　要：目的:通过对同一临床实验室两台不同的免疫分析系统进行方法比较和预期偏倚评估,探讨AFP在两化学发光分析系统之间检测数据是否具有可比性或检测结果偏倚是否在允许范围内,以确保不同免疫分析系统检测结果的准确性和一致性。方法:按照美国临床实验室标准化委员会(NCCLS)EP9-A文件的要求,以美国贝克曼ACCESS分析仪为比较仪器,贝克曼DXI800为试验仪器,用患者样品对AFP进行检测,对两分析系统之间的预期偏倚进行评估。结果:在所测定的AFP中,预期偏倚在方法线性范围内均可以接受。结论:根据NCCLS有关文件EP9-A对贝克曼ACCESS和贝克曼DXI 800化学发光分析系统进行方法比对及偏倚评估,测定表明两者具有很好的相关性。两个免疫测定系统测定AFP结果具有可比性。当同一实验室同一检验项目存在2个以上的检测系统时,应进行方法比对和偏差评估,以保证检验结果的可比性。Objective. To insure the accuracy of the testing results methodology and the anticipated bias of the two different immunity analytical systerm in the same clinial laboratory weres analyzed comparatively and evaluated to study whether AFP in the two immunity and analytical systerms was comparative or whether their testing results bias were within the limitation. Methods： Accroding to the NCCLS-Ep9-A, two different immunity analytical systerms, BECKMAN ACCESS（comparsion method） and BECKMAN DXI800 （laboratory method）, were used repectively to test the AFP of samples ande evaluate the outcome bias between the two systerms. Results. Among these testing results of AFP , theanticipated bias was acceptable within methodological linear limitation. Conclusion. The two immunity analytical systerm was comparative in testing AFP. But for the tests, which have more than two sets of analytical systerms, the analytical comparison and bias evalution should bu made. Only after accurate evalution konwledge about the bias of the items in the different analytical systerms was accuray and stability of testing results could be insured.

关 键 词：(NCCLS)EP9-A文件 化学发光分析仪 偏倚评估 方法比对 甲胎蛋白 

分 类 号：R446.62[医药卫生—诊断学]