改良抗体结合实验检测灭活狂犬病疫苗效价

目的:建立抗体结合试验检测狂犬病疫苗(aG株)效价的方法。方法:将待检测疫苗与疫苗标准品梯度稀释后分别加入人抗狂犬病毒免疫球蛋白国家标准品中和1 h,之后加入80%感染剂量的狂犬病毒CVS-11,体外中和1h后接种BSR细胞,培养24 h后免疫荧光染色,在显微镜下观察结果,通过检测剩余病毒量计算待检疫苗的效价,同时与小鼠中和试验法(NIH法)测定狂犬病疫苗效价进行比较。结果:2种方法对8个样品效价的检测结果无显著统计学差异(P=0.997,配对t检验)。结论:初步建立了改良抗体结合试验,可用于狂犬病疫苗中间产品的质量控制。

Establishment of Modified Antibody Binding Test for Potency Test-ing of Inactivated Rabies Vaccines

Objective： To develop a modified antibody binding test（M-ABT） for potency testing of rabies vaccine （aG stain）. Methods： Testing vaccine samples and reference vaccine were prepared by serial dilution, anti-rabies antibody national stand was added and incubated at 37℃ for 1 h, followed by another 1 h incubation with rabies virus CVS-11 for in vitro neutralization, then inoculated with BSR cells, cultured for 24 h, subjected to fluores-cence staining and fluorescent microscopy observation. The residual rabies virus was detected and vaccine potency was calculated. Vaccine potency was also determined by NIH methods. Results： A total of 8 samples were detect-ed by M-ABT and NIH, and no significant difference（P=0.997, paired t test） was found. Conclusion： M-ABT has been established and can be used for quality control in the manufacture of rabies vaccine.