基因Ⅰ型非洲猪瘟病毒(SD/DY-Ⅰ/21株)阳性血清定性标准样品的研制OA

SPF pigs were immunized with inactivated genotype Ⅰ African swine fever virus(ASFV)strain SD/DY-Ⅰ/21,and the positive serum of the immunized pigs was collected which was used to prepare qualitative reference material(RM).Toward this end,the positive serum of ASFV strain SD/DY-Ⅰ/21 was inactivated,titrated and then tested for purity and stability,followed by lyophilization.A total of five hundred bottles of RM for positive serum of genotype Ⅰ ASFV strain SD/DY-Ⅰ/21 were successfully prepared.The homogeneity and stability of the RM were detected and evaluated using indirect enzyme-linked immunosorbent assay(iELISA)commended in Diagnostic techniques for African swine fever(GB/T 18648-2020).Afterwards,the RM was characterized by nine different laboratories and tested for clinical trial.The results indicated that the RM was pure,homogenous,and free of exogenous virus contamination,showing good specificity,homogeneity and stability.The RM was stable after storage at-20℃ for at least 12 months,and at least 7 days at 4℃,25℃ and 37℃,respectively.The results of collaborative characterization performed by the nine laboratories all showed that the RM was positive for antibody against genotype Ⅰ ASFV.The RM prepared in this study is suitable for quality control,proficiency testing,as well as comparison and evaluation of detection reagents/kits,technicians and testing methods for serological detection of genotype Ⅰ ASFV.