Celercare M1 分析仪与 Beckman DXC800 分析仪检测结果的比对及偏倚评估
Comparison Analysis and the Bias Assessment of the Results between Celercare M1 and Beckman DXC800 Analyzer
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摘要: 为了探讨 Celercare M1 分析仪与 Beckman DXC800 分析仪常规生化检测结果的可比性, 为临床实验室认可与不同实验室检验结果的互认提供依据, 文章通过参考美国临床和实验室标准协会(CLSI)EP9-A2 文件, 以 Beckman DXC800 检测系统为参比方法, 以 Celercare M1 检测系统为待评方法, 使用以上两种方法对患者新鲜血清进行常规生化检测, 最后计算两个系统间各项目在医学决定水平处的系统误差, 并以美国临床实验室修正法案(CLIA’88) 允许总误差的 1/2 为标准来判断检验结果的可比性。实验结果显示, Celercare M1 检测系统与Beckman DXC800 检测系统测定结果相关性良好(R 0.975, P < 0.01), 各项目在医学决定水平处的偏倚均低于1/2 CLIA’88 标准, 表明两个检测系统的测定结果间具有良好的可比性。Abstract: To investigate the comparability of conventional biochemical assay results between Celercare M1 and Beckman DXC800 analyzer, and provide the basis for clinical laboratory accreditation and mutual recognition of test results in different laboratories, Beckman DXC800 detection system (comparison method) and Celercare M1 detection system (test method) were used respectively to make a determination for conventional biochemical items with fresh serum according to the EP9-A2 document of CLSI. We caculated the system bias of each item between test method and comparison method at the level of medical decision and judged the comparability of test results according to the half of CLIA’88 standard. It is shown that the correlation coefficient and the linear equation between Celercare M1 and Beckman DXC800 analyzer are excellent(R 0.975, P<0.01), the result biases for each item in medical decision levels are lower than 1/2 CLIA’88 acceptance standard. It is demonstrated that the measurement results between Celercare M1 detection system and Beckman DXC800 detection system have excellent comparability.
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