兔病毒性出血症灭活疫苗效力检验替代方法研究

Research on Alternative Method of Potency Test of Rabbit Haemorragic Disease Virus(RHDV) Inactivated Vaccine

为了采用血凝抑制(HI)试验方法替代兔病毒性出血症灭活疫苗效力检验的免疫攻毒方法,试验在制备了HI试验用兔出血症病毒血凝(HA)抗原、阳性血清、阴性血清的基础上,研究了免疫攻毒保护与免疫血清HI效价之间的平行关系,并进行了替代方法的应用。结果表明,当免疫血清HI效价不低于1∶32时,两种方法的检验结果符合率为100%,证明了该替代方法的可行性,也为下一步修订兔病毒性出血症灭活疫苗效力检验方法提供了数据支持。

In order to replace existing potency test of rabbit haemorragic disease virus( RHDV) inactivated vaccine with hemagglutination inhibition( HI) test,on the basis of HI antigen,positive serum and negative serum preparation,a parallel relation test between HI titre and clinical protection of immunization rabbits challenged with RHDV was carried out;While HI test was also applicated to potency test of the vaccine. The results show that HI titre of inoculazated rabbits should be no less than 1 ∶ 32,and the coincidence rate of the two methods is 100%,indicating the HI test is feasible. The results also provide data for revising China Veterinary Pharmacopoeia.