时间分辨荧光免疫法检测HBVPreS1Ag试剂盒的应用评价  

Application Value of Time-resolved Fluoroimmunoassay for Detecting Hepatitis B Virus PreSIAg

作　　者：谭玉华 林艳芬[2] 廖思红[3] 陈建起 孙勇 沈健 袁国悦 吴道贫 

机构地区：[1]广州市丰华生物工程有限公司,广州501730 [2]广州医学院第二附属医院检验科,广州510260 [3]中山大学附属第三医院输血科,广州510630

出　　处：《现代检验医学杂志》2013年第6期58-62,共5页Journal of Modern Laboratory Medicine

基　　金：广州经济技术开发区、广州高新技术产业开发区、广州出口加工区、广州保税区科技项目（重点科技攻关计划2010Q-P174）.

摘　　要：目的建立乙型肝炎病毒前S1抗原（HBVPreSlAg）时间分辨荧光免疫法（TrFIA），并对自研试剂盒检测PreSlAg的应用价值进行评价。方法对自研试剂盒的精密度、灵敏度、特异度、稳定性和参考值等分析性能指标进行评价；与对照试剂盒平行检测l020例样本，检验结果的一致性采用Kappa检验。采用时间分辨荧光免疫法检测PreSlAg和乙型肝炎病毒标志物（HBVDNA），用荧光定量聚合酶链反应（PCR）检测HBVDNA，探讨PreSlAg与HBVDNA之间的相关性并对比三者在临床样本中的阳性检出率。结果自研试剂盒符合企业内部栓定标准，批内变异系数小于10％，自研试剂盒灵敏度较酶联免疫法高，有效期为12个月；自研试剂盒与对照试剂盒检测结果的总符合率达98．82％，Kappa指数达0．9763；350例样本中PreSlAg检出率与HBVDNA检出率差异无统计学意义（x2=1．69，P〉0．05）；在HBVDNA阳性时PreSIAg与HBeAg的检出灵敏度一致（x2=0．21，P〉0．05）；但在HBVDNA阴性时特异性PreSlAg不及HBeAg（x2=50．24，P〈0．05）。PreSlAg和HBeAg的检出率均随HBVDNA浓度升高而升高；PreSIAg和HBeAg联合应用检出率（66．00％）高于HBVDNA检出率（49．43％）（x2=20．88，P〈o．05）。结论PreSlAg是反应HBV复制和传染性的一个重要补充标志物。自研试剂盒在预示HBV的感染、复制和传染性等方面具有重要的价值。Objective To establish a time-resolved fluoroimmunoassay（TrFIA） for detection hepatitis B virus PreSIAg and e- valuate the kit in application. Methods The self-made kit,s precision, sensitivity, specificity,stability, and the reference val- ue of the kit was evaluated,self-made kits and similar kits detected 1 020 cases of samples,the Kappa test was used for the consistency of detection results. TrFIA was used to detect the PreSIAg and hepatitis B virus markers, and HBV DNA was quantitatively detected using real-time PCR,then discussed the relationship between PreSiAg and HBV DNA, and contrast the positive rate between the three. Results The Self-made kit comply with internal standards. The coefficients of variation （CV） was less than 10%. The sensitivity of self-made kit was higher than ELISA kit. The validity of self-development kit was 12 months. The compliance rate of clinical research was reached 98.82%. Kappa index of the self-made kits and similar kits detection results was 0. 976 3. The difference between PreS1Ag positive rate and HBV DNA positive rate was not sig- nificant difference（x2= 1.69, P〉0.05）. The sensitivity of PreS1Ag was consistent with HBeAg in HBV DNA positive sam- ples （x2= 0.21, P〈0.05）. The specificity of HBeAg was better than PreS1Ag in H BV DNA negative samples （x2=50.24, P〈0.05）. The positive rate of PreS1Ag or HBeAg increased accompany with the HBV DNA concentration. The positive rate of the application of PreS1Ag combined with HBeAg was higher than the positive rate of HBV DNA in detection clinical samples （x2=20.88,P〈0.05）. Conclusion PreS1Ag is an important serum marker in HBV replication and infection. This study indicated their own development kit has important value in HBV infection,replication and infectious.

关 键 词：乙型肝炎病毒 前S1抗原 时间分辨荧光免疫法 

分 类 号：R392-33[医药卫生—免疫学]