乙型肝炎病毒E抗原检测方法性能的初步评价  

Preliminary evaluation on performance of detection method to E antigen of hepatitis B virus

作　　者：苏荣[1] 叶桂样[1] 罗娜[1] 杨延斌[1] 蒋开平[1] 张劲丰[1] 

机构地区：[1]佛山市中医院检验科,广东佛山528000

出　　处：《实验与检验医学》2013年第1期21-23,共3页Experimental and Laboratory Medicine

基　　金：广东省佛山市医学类科技攻关项目编号(201208028)

摘　　要：目的对采用电化学发光法测定乙型肝炎病毒E抗原(HBeAg)进行方法学性能的初步评价。方法严格参照美国临床及实验室标准协会(CLSI)EP10-A2文件,对电化学发光法测定HBeAg结果进行统计,计算其偏差、总不精密度及其截距、斜率、非线性、交叉污染率、漂移性,并与各浓度对应设定值作比较。结果HBeAg高、中、低值3种浓度分别为10.30、5.20、0.10COI,测定结果与均值偏倚分别为-0.02、0.00、0.00,总不精密度分别为0.311,0.00、0.00%,截距:0.00800,斜率:0.99720,交叉污染:0.15000,非线性:-0.01140,漂移:0.00400,(P>0.01)。结论德国Roch E-170全自动电化学发光分析仪测定HBeAg偏差、总不精密度均在允许范围内;有良好的线性关系,交叉污染率较低,稳定性很好,能满足临床常规检测需求。Objective To make preliminary evaluation of methodology performance about detection of HBeAg by using electrochemiluminescence.Methods Statistical stastical analysis of HbeAg results detected by ECLIA was couducted and the deviation,total imprecision and intercept,slope,nonlinearity,cross-contamination rate,drift were calculated and then compared with each corresponding set values of different concentration by strictly referring to the EP10-A2 documents of the American Clinical and Laboratory Standards Institute（CLSI）.Results The values of high,medium and low concentration of HbeAg were 10.30,5.20,0.10 COI respectively,the values of bias were-0.02,0.00,0.00 respectively.The values of total imprecision were 0.311%,0.00%,0.00% respectively.The intercept was 0.00800,the slope was 0.99720,the cross-contamination rate was 0.15000,the nonlinearity value was-0.01140 and the drift was 0.00400（P〉0.01）.Conclusions The deviation and total imprecision of detecting the concentration of HbeAg by full automatic electrochemiluminescence analyzer Roch E-170 were within the allowable scope.The machine has good linear relationship,low cross-contamination rate and good stability to meet the clinical demand for routine test.

关 键 词：电化学发光 乙型肝炎病毒E抗原 EP10-A2 性能评价 

分 类 号：R446.62[医药卫生—诊断学] R512.62[医药卫生—临床医学]