非洲马瘟病毒(AV1311株)核糖核酸标准物质的研制OA北大核心CSTPCD

Reference materials(RMs)are the gold standard for molecular diagnosis technology.In view of the lack of African horse sickness virus(AHSV)RMs in China,AHSV(AV1311 strain)nucleic acid RM(NARM)was successfully prepared using AV1311 strain as raw material by virus culture,inactivation,packaging,and characteristic testing.At the same time,a digital PCR method was established to evalu-ate the homogeneity,stability,and quantification of the NARM in collaboration with 9 laboratories,and carried out clinical trials.The results of homogeneity evaluation showed there was no statistical differences within groups and between groups,and the samples were homogeneous.The stability investi-gation revealed that the NARM could be stored at-20 ℃ for 6 months,4 ℃ for 7 days,and at 25 ℃ for 24 hours.It could undergo up to 5 freeze-thaw cycles and requires transport on dry ice.The certified value of the NARM was(6.9±1.1)X 103 copies/μL.Clinical trials demonstrated that the prepared NARM had good interoperability with clinical samples.In conclusion,the prepared NARM has accurate quantification,good homogeneity and stable values,which had been successfully evaluated by National Administrative Committee[GBW(E)091272]and provides a material basis for the prevention of AHS in China.