不同生化分析系统间检测结果的偏差评估及应用

目的 通过对同一临床实验室不同生化分析系统进行方法对比和预期偏差评估，探讨不同生化分析系统之间检测结果是否具有可比性或检测结果的偏差是否在允许的范围内。方法 按照EP9-A文件的要求，以美国强生Vitros-750生化分析仪为对比方法，日立7600生化分析仪为试验方法，用患者血清对丙氨酸氨基转移酶、总蛋白、总胆红素等14个生化项目进行检测，计算相关系数和直线回归方程，对两分析系统之间的预期偏差进行评估。结果 在所检测的14个项目中，总胆红素和直接胆红素两系统测定结果的预期偏差不能被接受；其余项目测定结果的预期偏差可以接受。结论 当实验室内同一检测项目存在两套以上分析系统时，应对其进行方法对比和偏差评估，才能保证检测结果的准确稳定。

The evaluation of the outcome bias between two different biochemical analysis systems under the same laboratory conditions

Objective This trial was performed to evaluate the comp arability of the test outcome or the acceptability of the outcome bias of different biochemical analysis systems under the same laboratory conditions. Method According to the profile NCCLS EP9 A, two different biochemical analysis systems, Johnson Vitros 750(comparison method) and Hitachi 7600(laboratory method), were used respectively to test 14 serological items such as ALT, TP, and TB to obtain the correlation coefficient and the linear equation. Then the coefficient and the equation were used to evaluate the outcome bias between these two systems. Result Among these 14 tests, the outcome biases of 2 (TB and DB) were not acceptable. Conclusion In order to insure the accuracy and the stability of the test outcome, method comparison and bias evaluation should be employed when using different biochemical analysis system under the same laboratory conditions.