应用定量RT-PCR对猪瘟兔化弱毒疫苗的质量评价研究

为进一步验证猪瘟兔化弱毒(HCLV)疫苗荧光定量RT-PCR(qRT-PCR)与兔体定型热试验之间存在正相关性,本研究利用qRT-PCR方法对278批次HCLV疫苗进行检测,分别检测其疫苗含量及牛病毒性腹泻病毒(BVDV)污染情况。结果表明,278批次猪瘟疫苗中有66批(24%)疫苗含量达不到规程标准,有42批(15%)疫苗存在BVDV污染;从所检疫苗中抽取6份qRT-PCR检测HCLV含量较低的疫苗,采用兔体定型热试验进行验证,两种方法结果吻合,表明qRT-PCR方法可以作为评价猪瘟疫苗质量的一种备选方法。

Qualification of the C-strain-based vaccines against classical swine fever using quantitative RT-PCR

Our previous studies showed that positive correlation existed between the quantitative RT-PCR(qRT-PCR) detection and body fever response method in rabbits for quality assay of classical swine fever virus(CSFV) C-strain-based vaccine(HCLV).In this study,we detected 278 batches of finished products of HCLV from 20 manufactures using the qRT-PCR for detecting the virus contents and bovine viral diarrhoea virus(BVDV) contaminant.The results indicated that 24%(66/278) of vaccine batches was under the national standard for the virus contents,and 15%(42/278) of which was contaminated with BVDV.Furthermore,the results of body temperature responses in rabbits were consistent with the qRT-PCR results on 6 selected vaccine batches,which demonstrated qRT-PCR could be an alternatives method to be used for quality control assay in process of HCLV production.