两种仪器不同检测原理测定免疫球蛋白G的比对分析

目的将同一临床实验室不同检测原理的2台检测仪器测定的免疫球蛋白G（IgG）测定结果进行对比，分析2台仪器的IgG测定结果的可比性。方法分别在德国BN-Ⅱ全自动特种蛋白分析仪和日立全自动7080生化分析仪器上测定患者的血清IgG，将所得结果进行对比分析，计算试验方法（Y）和比较方法（X）之间的相对偏差（SE％）。以CLIA’88规定的允许误差的1／2为标准，判断不同检测系统的可比性。结果两种检测系统间免疫球蛋白IgG的测定结果的误差临床均可以接受。结论不同检测系统即德国BN-Ⅱ全自动特种蛋白分析仪和日立全自动7080生化分析仪测定IgG检测结果具有可比性。当同一实验室同一检测项目存在两种以上检测系统时，应进行方法比对和偏差评估，以保证检验结果的可比性。

Comparasion of the IgG tested by two detection instruments of two different principles

Objective To compare the results of IgG which was tested by 2 detection instruments of 2 different testing principles in the same clinical laboratory to analyse the comparability of the two different test results. Methods Test the patients＇IgG with Dade Behring BN II and HITACHI 7080 biochemical analyzer separately, and conduct a comparative analysis on the results, and calculate the relative deviation（SE%）of the test methods （Y） as well as the comparative approach（X）. Set half of the CLIA 88＇allowable error as standard, and judge the comparability between the different detection systems. Results The errors of the testing IgG of the 2 detection systems were acceptable clinically. Conclusion The comparability of the two detection systems（Dade Behring BN II and HITACHI 7080 biochemical analyzer）dose exist. When there are two or more detection systems for the same testing program, comparison of the methods and bias estimation should be done to guarantee the comparability of the testing results.