雅培i2000SR和Beckman DXI800全自动化学发光仪测定AFP、CEA水平的可比性研究

摘要

Objective To investigate the comparability between Abbortt i2000SR and Beckman DXI800 automatic immunoassay analyzers for the detection of AFP and CEA.The anticipated bias were analyzerd comparatively and evaluted to study whether their testing results bias were within the limitation. Methods According to National Committee for Clinic Laboratory Standards(NCCLS)document EP9-A2,Abbortt i2000SR(comparasion method)and Beckman DXI800(labortory method) automatic immunoassay analyzers were used respectively to measure the serum concentrations of AFP and CEA of 40 patients and evaluate the outcome bias between the two analyzers. Results Both of the two instruments had a great correlation and the correlation coefficient of each item was above 0.99.Among these testing of AFP and CEA,the anticipated bias was acceptable within methodogical linear limitation.The two immunoassay analyzers were comparative in testing AFP and CEA. Conclusion When using two or more detection analyzers to analyze the same project,method comparison and bias estimation can ensure the comparability of measurement results.%目的：探讨雅培i2000SR和Beckman DXI800全自动化学发光仪检测甲胎蛋白（AFP）和癌胚抗原（CEA）结果的可比性、偏倚评估及临床可接受程度。方法根据美国临床实验室标准化委员会（NCCLS）EP9-A2文件的要求，收集40例患者不同浓度的新鲜血清，分别在两台仪器上进行AFP、CEA测定，共得到40组数据。以雅培i2000SR化学发光仪为比较方法，Beckman DXI800作为实验方法，对检测结果进行方法比对和偏倚评估。结果 AFP和CEA两个项目的检验结果在两台仪器上的相关性较好，相关系数r均＞0.99，AFP和CEA在医学决定水平上的预期偏倚均可接受，AFP和CEA在两台化学发光仪上的检测结果具有较好的一致性。结论当同一实验室出现不同仪器检测相同检验项目时，应进行方法比对和偏差评估，以保证检验结果的可比性。