CAJ | 학술논문

目的:用单克隆抗体制备的双抗夹心ELISA法快速检测灭活乙型脑炎疫苗中的乙型脑炎病毒包膜蛋白(E)的含量,并探讨其替代蚀斑减少中和试验法的可行性.方法:将疫苗样品用蚀斑减少中和试验法测定,同时选定一批疫苗为参考疫苗,用双抗夹心ELISA法检测.结果:用双抗夹心ELISA法测得的中和指数(T_E)为1.595~1.655.用蚀斑减少中和试验法测得的中和指数(T_P)为1.367~1.932.经F检测,两种检测方法的灵敏度有极显著差异(F=56.25,P<0.01), 用t检验法对这两种检测方法进行统计分析,表明两组测定值的差异无统计学意义(t=0.079 3,P>0.05).结论: 双抗夹心ELISA法与蚀斑减少中和试验法测得的中和指数(T)呈正相关性;与蚀斑减少中和试验法比,双抗夹心ELISA法具有重复性好、成本低、快速等优点.用双抗夹心ELISA法取代蚀斑减少中和试验法测灭活乙型脑炎疫苗效价是可行的.
목적:용단극륭항체제비적쌍항협심ELISA법쾌속검측멸활을형뇌염역묘중적을형뇌염병독포막단백(E)적함량,병탐토기체대식반감소중화시험법적가행성.방법:장역묘양품용식반감소중화시험법측정,동시선정일비역묘위삼고역묘,용쌍항협심ELISA법검측.결과:용쌍항협심ELISA법측득적중화지수(T_E)위1.595~1.655.용식반감소중화시험법측득적중화지수(T_P)위1.367~1.932.경F검측,량충검측방법적령민도유겁현저차이(F=56.25,P<0.01), 용t검험법대저량충검측방법진행통계분석,표명량조측정치적차이무통계학의의(t=0.079 3,P>0.05).결론: 쌍항협심ELISA법여식반감소중화시험법측득적중화지수(T)정정상관성;여식반감소중화시험법비,쌍항협심ELISA법구유중복성호、성본저、쾌속등우점.용쌍항협심ELISA법취대식반감소중화시험법측멸활을형뇌염역묘효개시가행적.
Objective: To investigate the feasibility of Sandwich ELISA with neutralizing McAbs against encephalitis B virus E protein for rapid detection of eucephalitis B virus E protein content in inactivated encephalitis B vaccine as a substitutive method to the plaque-reduction test(PRT).Methods: The potency of encephalitis B vaccine was tested by both PRT and Sandwich ELISA assay.A batch of reference vaccines was provided by Liaoning Yisheng Bio-Pharmaceutical Co.Ltd.Results: Analysis of the data indicated that there was a significant positive correlation of T values (neutralizing index) between Sandwich ELISA assay and relevant PRT of encephalitis B vaccine. The range of T_E values measured by Sandwich ELISA assay of a batch of encephalitis B vaccine was between 1.595 and 1.655, while the range of T_P values measured by PRT was between 1.367 and 1.932 (P<0.01 by F test for sensitivity of the 2 methods,P>0.05 by t test for T values measured by the 2 methods).Conclusion: The potency of inactivated encephalitis B vaccine detected by Sandwich ELISA assay is accordant with that detected by the PRT.Sandwich ELISA assay of encephalitis B vaccine shows better reproducibility, lower cost and faster than PRT. Sandwich ELISA assay of encephalitis B vaccine is a potential substitutive method for plaque-reduction test.