猪瘟病毒阴性和阳性血清(细胞中和试验)参考品的制备  

Preparation of reference negative and positive sera against classical swine fever virus for the neutralization tests in cells

作　　者：戴志红[1] 蒋卉[1] 关孚时[1] 孙海燕[1] 李翠[1] 张秀英[1] 徐璐 王琴 刘景利[3] 王杰[3] 徐珊珊[3] 赵丹彤 石宝兰 关永梅 张慧芳 刘长辉 何侠 侯军 高云飞 王在时[1] 

机构地区：[1]中国兽医药品监察所,北京100081 [2]国家猪瘟参考实验室,北京100081 [3]中国农业科学院哈尔滨兽医研究所,黑龙江哈尔滨150001 [4]金宇保灵生物药品有限公司,内蒙古呼和浩特010030 [5]福州大北农生物技术有限公司,福建福州350014 [6]南京天邦生物科技有限公司,江苏南京211102

出　　处：《中国预防兽医学报》2013年第12期997-1001,共5页Chinese Journal of Preventive Veterinary Medicine

基　　金：国家十一五科技支撑计划(2006BAD06A10);农业部农产品质量安全监管专项(2130109)

摘　　要：为制备和标定猪瘟病毒(CFSV)阴性和阳性血清细胞中和试验参考品,本实验制备了CSFV阴性、弱阳性和强阳性血清,通过过滤、分装、冻干、熔封,获得一组候选物。按常规方法进行各项指标的检测,并在国内6个实验室对其细胞中和效价进行了协作标定和定值。结果显示:这组候选物物理性状、无菌检验、安全检验、支原体检验、真空度测定均合格;剩余水分小于3%;特异性检验结果均为口蹄疫病毒、伪狂犬病病毒、猪繁殖与呼吸综合征病毒、猪细小病毒、牛病毒性腹泻/粘膜病毒抗体阴性;残余CFSV免疫荧光和套式RT-PCR核酸检测结果均为阴性;均匀性检验结果表明,各组测定数据的均值与方差无显著差异(p>0.05);在-20℃的保存有效期约为16.8年。协作标定定值的细胞中和效价分别为:阴性(200905-1)、1∶100.98±0.13(200905-2)、1∶103.31±0.35(200905-3)。该候选物可以作为参考品。To prepare and characterize the reference negative and positive sera against classical swine fever virus （CSFV） for the neutralization tests, a set of freeze-dried candidate sera against CSFV were prepared, examined and collaborative studied. The tests such as character, sterility, safety, mycoplasmas, and vacuum degree were qualified by routing quality assays, the residual moisture contents were less than 3%, the antibodies against foot and mouth disease, pseudorabies, porcine reproductive and respiratory syndrome, porcine parvovirus and bovine viral diarrhea-mucosal disease were all negative by ELISA assays, and the remainders of CSFV were all negative assayed by IFA and nested RT-PCR. Homogeneity examined by t- test and F- test revealed that average and variance of imerior-group inter-group did not showed significant difference （c~=0.05）. Accelerated thermostability test calculated the candidates stored at -20 ~C would be valid for about 16.8 years. Neutralization titers by collaborative study in 6 laboratorises were negative （200905-1）, It could be concluded that the candidates could be used as reference materials.

关 键 词：猪瘟病毒 血清 参照品 均匀性 热加速稳定性 

分 类 号：S852.65[农业科学—基础兽医学]