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作 者:唐妮娜[1]
出 处:《医学理论与实践》2013年第21期2823-2824,2827,共3页The Journal of Medical Theory and Practice
摘 要:目的:探讨罗氏Cobas E411与Cobas E601两台电化学发光免疫分析仪检测结果的可比性。方法:参考美国临床和实验室标准协会(CLSI)EP9-A2文件,以E411为比对方法(X),E601为实验方法(Y),检测患者样本中甲胎蛋白(AFP)、癌胚抗原(CEA)、糖类抗原125(CA125)、糖类抗原199(CA199)的含量,并对实验数据进行比对分析。结果:两系统之间的相关性好,在医学决定水平处的预期偏倚均可接受。结论:使用不同检测系统检测同一项目时,应进行比对分析和偏倚评估,以保证系统间检测结果的可比性。Objective: To investigate the comparability of test results of two electrochemiluminescence immunoassay analyzer between Roche Cobas E411 and Cobas E601. Methods: According to United States Clinical and Laboratory Standards Institute (CLSI) EP9-A2 document, E411 was acted as comparison method (X) and E601 was as the experi- mental method (Y). Alpha fetoprotein (AFP), carcinoembryonic antigen (CEA), carbohydrate antigen 125 (CA125) and carbohydrate antigen 199 (CA199) levels of patient samples were tested and the results were analyzed. Results: The correlation between the two systems is good and the bias is acceptable in the medical decision level. Conclusion: The comparative analysis and bias evaluation systems should be carried out to ensure the comparability of test results when the same items are detected with different detection systems.
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