血清结合胆红素酶法测定在自动生化分析仪上的应用  

Application of enzymatic assay for serum conjugated bilirubin on automatic analyzer

作　　者：赵建华[1] 蒋胜高[1] 罗浔阳[2] 王毓三[1] 

机构地区：[1]江苏省肿瘤防治研究所,江苏省临床检验中心南京210009 [2]南京大学医学院附属鼓楼医院检验科

出　　处：《临床检验杂志》2004年第6期419-422,共4页Chinese Journal of Clinical Laboratory Science

摘　　要：目的　建立酶法测定血清结合胆红素的全自动分析方法 ,并在肝胆疾病患者中临床应用。方法　通过试剂的合理组合 ,分析参数和操作程序的设定 ,建立结合胆红素 (CB)的全自动分析方法 ,同时对总胆红素进行自动化酶法测定。结果　酶法CB测定 :精密度 ,批内n =2 0 , x =6 .4 8μmol/L ,s=0 .11,CV =1.7%和n =2 0 , x =77.9μmol/L ,s=0 .4 2 ,CV =0 .5 3% ;批间n =10 , x =9.4 6 μmol/L ,s=0 .17,CV =1.83%和n =10 , x =5 9.7μmol/L ,s=1.4 3,CV =2 .39% ;线性范围至少可达 340 μmol/L ;比对实验 :与Beckman重氮法试剂 (在BeckmanCX7型生化分析仪上 )比较 ,Y(酶法 ) =0 .75 9X1- 2 .82、r =0 .991,与IagnosticumRT重氮法试剂 (日立 76 0 0 0 2 0型分析仪 )比较 ,Y =0 .84 1X2 - 4 .39、r=0 .96 3。临床研究显示 :与重氮法直接胆红素值相比 ,本法测定CB值能够更灵敏地反映黄疸患者的胆红素分泌功能。结论　建立的CB全自动分析方法具有良好的分析特性 ,可在临床推广应用。Objective To establish an automated enzymatic assay specific for serum conjugated bilirubin (CB),and to investigate its value of clinical application.Method By reasonably organizing reagents, designing analytic parameters and programming operation procedure,total and conjugated bilirubins were determined on Hitachi 7600-020 Automatic Analyzer.Results The intra-assay CVs were 1.7% and 0.53% (n=20) at CB concentrations of 6.48μmol/L and 77.9μmol/L,respectively.The inter-assay CVs were 1.83% and 2.39% at 9.46μmol/L and 59.7μmol/L,respectively.The linearity range for CB was extended to at least 340 μmol/L.The values of serum CB (Y) determined by using this assay correlated well with those of direct bilirubin (X) obtained by diazo-dye method [Y=0.759X(Beckman Kit)-2.82,r=0.991 and Y=0.841X(Iagnosticum RT Kit)-4.39,r=0.963].The clinical study showed that the values of CB based on the method reflected more sensitively the pathophysiological conditions of hepatobiliary disease patients with jaundice than total or direct bilirubin.Conclusion The proposed automatic assay for CB shows good analytical specificity and is valuable for clinical application.

关 键 词：结合胆红素 酶法测定 自动生化分析仪 重氮法 黄疸 

分 类 号：R442.4[医药卫生—诊断学] R446.1[医药卫生—临床医学]