通过用单克隆抗体制备双抗体夹心ELISA,快速检测狂犬病疫苗中狂犬病毒糖蛋白(G)的含量,将狂犬病疫 苗的检定时间由28天缩短至2个工作日,以此缩短疫苗库存待检时间,提高疫苗的生产和销售效率,并最终替代 NIH动物法。将待检的狂犬病疫苗样品在同一性别12～14g昆明鼠体内作效力检定试验(NIH),同时用双抗体夹 心ELISA检测狂犬病疫苗中狂犬病毒G蛋白含量,用Microsoft Office Excel做出标准品和各样品疫苗的线性关 系图并计算出疫苗效力值E-NIH。结果用双抗体夹心ELISA所得的E-NIH与对应的小鼠效力试验所得结果M- NIH之间呈正相关性;同一批狂犬病疫苗分次测得E-NIH值在2．41～5．85之间,而相应的M-NIH值在5．11～ 10．19之间。从而得出E-NIH与相应的M-NIH之间存在明显的线性关系;与NIH法比较,ELISA具有重复性好、 成本低、快速等优点;用双抗体夹心ELISA替代小鼠效力试验是可能并可行的。

Sandwich ELISA with neutralizing McAbs against rabies virus glycoprotein can be used as a substitutive method to the NIH test. Kunming mice (12-14g) were inoculated ip with different dilution of rabies vaccines two times for NIH test (M-NIH), then challenged with CVS strain of rabies virus. At the same time, glycoprotein of rabies vaccines were tested with sandwich ELISA. A reference vaccine whose efficacy had been known was also tested with sandwich ELISA. Analysis of the data indicated that there was a significant positive correlation (0. 98) between E-NIHs and relevant M-NIHs of rabies vaccines. The range of E-NIHs resulted from one batch of rabies vaccine was between 2. 41 and 5. 85 while the range of M-NIH was between 5. 11 and 10. 19. There was a significant linear relation between E-NIHs and M-NIHs of rabies vaccines. E-NIHs showed a better reproducibility, lower cost and faster than M-NIHs. ELISA is a potential substitute of rabies vaccine NIH test.