两种方法对Ⅰ型Sabin株脊髓灰质炎病毒神经毒力的共同评价  

Joint evaluation of type Ⅰ Sabin strain poliovirus neurovirulence by two different assays

作　　者：丁玲 郭羽 赵素玲 马萌 孙千一 马燕 张亮 管茜茜 王辉 李拓 李娜 Ding Ling;Guo Yu;Zhao Suling;Ma Meng;Sun Qianyi;Ma Yan;Zhang Liang;Guan Qianqian;Wang Hui;Li Tuo;Li Na(Department of Quality Control, Beijing Institute of Biological Products Co., Ltd., Beijing 100176, China;General Manager’s office, Beijing Institute of Biological Products Co., Ltd., Beijing 100176, China)

机构地区：[1]北京生物制品研究所有限责任公司质量检定室,100176 [2]北京生物制品研究所有限责任公司总经理办公室,100176

出　　处：《国际生物制品学杂志》2019年第4期175-179,共5页International Journal of Biologicals

摘　　要：目的研究PCR和限制性内切酶突变分析(mutant analysis by PCR and restriction enzyme cleavage,MAPREC)技术和猴体神经毒力试验(monkey neurovirulence test,MNVT)评价同一批Ⅰ型Sabin株脊髓灰质炎(脊灰)病毒神经毒力的结果差异.方法采用MAPREC技术,检测Ⅰ型Sabin株脊灰病毒神经毒力关键位点480和525位点突变率;采用MNVT病理切片分析,评价Ⅰ型Sabin株脊灰病毒神经毒力.结果 MAPREC检测待测样品核酸480和525位点突变率均值为0.460%,低于高突变参考品的1.288%.MNVT切片结果分析表明,有效猴病变分值差合格.结论对同一批样品,MAPREC与MNVT分析结果一致.Objective To study the difference between the neurovirulence results of the same type Ⅰ Sabin strain poliovirus using mutant analysis by PCR and restriction enzyme cleavage (MAPREC) and monkey neurovirulence test (MNVT). Methods The MAPREC assay was used to detect the point mutation rate of the amino acids 480 and 525, key sites for the virulence of type Ⅰ Sabin strain poliovirus. The paraffin sections of the MNVT were analyzed to evaluate the neurovirulence of the same virus strain. Results The average mutation rate of 480 and 525 sites in MAPREC assay was 0.460%, which was lower than 1.288% of high mutant virus reference. The paraffin sections results of MNVT showed that the lesion score difference of effective monkeys was qualified. Conclusion The MAPREC result of the same batch of samples is consistent with the MNVT result.

关 键 词：脊髓灰质炎病毒 疫苗 减毒 神经毒力 序列分析 RNA 动物实验 

分 类 号：R186[医药卫生—流行病学]