Development of national reference materials for Japanese encephalitis virus nucleic acid detection reagents
Objective To establish a national reference material for the nucleic acid detection re-agent of the Japanese encephalitis virus and set its quality standards for it.Method By reviewing and confirm-ing of 24 pathogen cultures,conducting whole genome sequencing and genotyping,a national reference materi-al for Japanese encephalitis virus nucleic acid detection reagent was developed.Multiple laboratories assisted in determining the quality standards of the reference material,as well as evaluating its uniformity and stability.Results The national reference sample for the nucleic acid testing reagent for Japanese encephalitis virus includ-ed 10 negative,14 positive,1 minimum detection limit,and 1 precision sample.The quality standard states that all 10 negative reference samples should test negative.At least 13 out of the 14 positive reference samples should be detected.The precision reference should be tested 10 times,all of which should be positive for Japanese en-cephalitis virus,with the CV of their detection values not exceeding 5.0%.The minimum detection limit refer-ence substance must be diluted 1∶100 times or more to test positive for Japanese encephalitis virus.The uniformi-ty and stability of the reference material meet the required standards.Conclusion This reference material can be used for quality control and evaluation of Japanese encephalitis virus nucleic acid detection reagents.
Japanese encephalitis virusNucleic acid testing reagentsGenotypingNational ref-erence
NETL
NSTL
万方数据
