改良酶法肌酐测定试剂的研制

Development of improved enzymatic creatinine reagents

目的探讨建立一种改良酶法肌酐（Cr）测定试剂,并考察其与进口Cr测定试剂（日本东洋纺公司酶法Cr试剂）对血清测定的可比性及偏倚。方法采用酶法测定Cr反应前后吸光度的变化,探讨试剂各成分和浓度对检测性能的影响,并在同一台全自动生化分析仪上同时测定两种试剂的空白吸光度（A值）、分析灵敏度,对自主研发试剂的精密度、线性范围及方法学指标进行评价。结果自主研发试剂的空白A值为0.009,分析灵敏度的A值变化率为0.13,优于进口试剂。自主研发试剂高、低值血清测定变异系数分别为1.5%和1.1%;线性范围为0-2 850μmol/L;方法学比对回归方程为Y=0.98 X＋1.15,r=0.999;估计偏倚低于允许误差。以相对偏差不小于10%作为有明显干扰的评判指标,结果显示35mmol/L肌酸、3.42mmol/L胆红素、0.03g/L维生素C、5g/L血红蛋白、1 450浊度乳糜对高、低值浓度标本检测结果均无干扰。结论自主研发的Cr测定试剂性能良好,与进口试剂之间具有良好的相关性,符合临床应用基本要求。

Objective To develop improved enzymatic creatinine（Cr）assay reagents（self-RD）,and to investigate their application on serum detection by comparing with imported commercial Cr reagents（enzymatic Cr reagents from Toyobo）Methods Enzymatic method was used to evaluate the effect of every component and different concentrations of reagents on Cr assay by detecting the alteration of absorbance of Cr before or after the reaction.Meanwhile,the blank absorbance and analysis sensitivity of self-RD and imported reagents,the technical indicators of precision,linearity,as well as method comparison of self-RD reagents,were detected on the same automatic biochemical analyzer.Results The blank absorbance of self-RD reagents was 0.009,and the detection sensitivity was 0.13,better than that of imported Cr reagents.The coefficient of variation（CV）of high and low values of serum of self-RD reagents were 1.5%,and 1.1%,respectively.The linear range was 0-2 850μmol/L and the method comparison result was Y=0.98 X＋1.15（r=0.999）.The expected bias was less than the allowable error region.Using relative deviation≥10% as an index to evaluate the existence of significant interference,it shows that 35mmol/L of creatine,3.42mmol/L of bilirubin,0.03g/L of vitamin C,5g/L of hemoglobin and 1450 FTU chyle in both low and high concentration serum samples did not interfere with the test result.Conclusion The quality of self-RD reagents was good,and there was a good relativity between selfRD reagents and imported Cr reagents with excellent quality.This indicates the self-RD reagents could satisfy the application requirements of the clinics.