总胆红素氧化酶法检测系统的性能评价

目的评价氧化酶法测定血清总胆红素（TBil）的性能。方法用氧化酶法测定血清TBil,探讨氧化酶法的精密度、线性、分析灵敏度、抗干扰性和回收率,并与改良J-G法进行比较。结果 TBil的高、低浓度样本批内CV分别为0.38%、0.78%,日间CV分别为1.78%、2.73%;平均回收率为101.2%;分析灵敏度为1.23μmol/L;线性范围为1.23～574.40μmol/L;2种方法相关性良好,直线回归方程为Y=1.105X-1.11,r=0.998。血红蛋白、维生素C和脂肪乳分别为4.8 g/L、500 mg/L和5%时对氧化酶法测定血清TBil不产生干扰。结论氧化酶法具有良好的精密度、线性范围和抗干扰能力,与改良J-G法具有很好的一致性,适用于临床常规检测。

Evaluation on the performance of total bilirubin oxidase assay system performance

Objective To evaluate the performance of serum total bilirubin（TBil） determination by oxidase method.Methods Serum TBil was determined by oxidase method,and the method′s precision,linearity,analytical sensitivity,anti-interference ability and recovery rate were evaluated.The method was compared with the modified J-G method.Results The within-run coefficients of variation（CV） of high and low TBil concentration samples were 0.38% and 0.78% respectively.The day to day CV of high and low TBil concentration samples were 1.78% and 2.73% respectively.The average recovery rate was 101.2%.The analytical sensitivity was 1.23 μmol/L,and the linear range was from 1.23 to 574.4 μmol/L.There was a good correlation between the 2 methods,and the linear regression equation was Y = 1.105X-1.11（r=0.998）.There was no interference when hemoglobin,vitamin C and fat emulsion were 4.8 g/L,500 mg/L and 5% for serum TBil oxidase.Conclusions Oxidase method has good precision,linear range and anti-interference ability and has a good consistency with the modified J-G method.It is suitable for routine clinical testing.