【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。更多还原

【Abstract】 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 revealedthat average and variance of interior-group inter-group did not showed significant difference(α=0.05). Accelerated thermostability test calculated the candidates stored at-20 ℃ would be valid for about 16.8 years. Neutralization titers by collaborative study in 6 laboratorises were negative(200905-1), 1∶100.98±0.13(200905-2) and 1∶103.31±0.35(200905-3). It could be concluded that the candidates could be used as reference materials.更多还原