氧化酶法肌酐测定的检测方法改良

An Improved Oxidase Method for Determining Creatinine in Blood and Urine

目的：通过调整方法学参数改进现用肌酐试剂在日立7600-020生化分析仪上的测试性能。方法在日立7600-020生化分析仪上，将豪迈公司氧化酶法肌酐试剂进行方法改良，然后参照CLSI方法学评价相关文件进行评估，具体指标有准确度、精密度、干扰试验、线性范围和参考区间。结果通过方法改良的肌酐测试系统性能指标为：偏倚（bias）是2.51%；批内不精密度（CVw）为2.43%；批间不精密度（CVb）为3.05%；线性范围为33-9105 umol/L；干扰试验，改良法优于原法；参考区间两种方法相符合。结论通过改良的肌酐测试系统优于原方法学系统。

Objective To improve the test by adjusting the methodological parameters of the creatinine reagent in Hitachi 7600-020 biochemical analyzer. Methods To adjust the methodological parameters of the creatinine reagent and evaluate the oparation performance （including：accuracy,precision, interference test, linear range and reference interval）according to the method of CLSI. Results Improved oparation performance： The bias was 2.51%; Within （CVw） was 2.43% and be-tween-batch precision （CVb） was 3.05%;the linear range was 33-9 105 umol/L; Interference test： the improved method is better than the original method; the reference interval is consistent with the original method. Conclusion The improved method is better than the original method.