时间分辨荧光免疫分析技术定量测定乙型肝炎病毒五项指标的应用评价

Estimation of Time-Resolved Fluorescence Immunoassay On Detection of five Markers of Hepatitis B Virus

目的:评价时间分辨荧光免疫分析技术(TRFLA)检测乙型肝炎病毒标志物(HBV-M)五项指标(HBsAg、HBsAb、HBeAg、HBeAb、HBcAb)的应用价值。方法:采用TRFIA法对其配套试剂盒进行准确性和重复性测试;然后对108例随机样本采用TRFIA与酶联免疫吸附试验(ELISA)两种方法同时检测HBV-M五项指标;最后对两种方法的差异指标用微粒子酶免疫分析(MELA)法作复核测定。结果:TRFIA检测HBV-M五项指标的准确性和重复性全部符合标准;两种方法检测结果符合率达95.4%以上,各指标阴阳性结果经配对资料x^2检验均差异无显著性(P>0.05);TRFIA与MEIA复核结果高度相符。结论:TRFIA作为一种高灵敏度的定量方法,对HBV-M五项指标的测定,能为乙肝的临床诊断、疗效观察提供动态数据,并为接种乙肝疫苗提供可靠依据,是一种比较理想的定量检测方法。

Objective To estimate the value of the time-resolved fluorescence immunoassay（TRFIA） on detecting five im- mun markers （ Hepatitis B surface antigen, Hepatitis B surface antibody, Hepatitis B ＂e＂ antigen, Hepatitis B ＂e＂ antibody, Hepatitis B core antibody） of hepatitis B virus. Methods Measured the accuracy and the duplication by TRFIA for the necessary reagent box;and then, five immun markers of hepatitis B virus of 108 random samples were detected by TRFIA and enzyme linked immunosorbent assay（ ELISE ） ;in the end, reexamined the difference targets of two methods by micro particl enzyme immunoassay（MEIA）. Results The accuracy and the duplication of TRFIA conformed to the standard ;the result＇ s accordant ratio of two methods was above 96.3% ,there was no remarkable significance in the negative targents and positive targents by paired Chi-square test （ P 〉 0.05 ） ;the result of reexamining by MEIA highly accorded with that by TRFIA. Conclusion As a high-sensitive quantitative method on detecting the five immun markers of hepatitis B virus by TRFIA , can provide the dynamic data for clinical diagnosis and the curativ effect observation of hepatitis B , and it can also supply reliable basis for the vaccination of hepatitis B, so it is a perfect quantitative method.