摘要
目的建立乙型脑炎病毒核酸检测试剂国家参考品,确定其质量标准。方法通过对24份病原体培养物的复核、确证,全基因组测序及基因分型,组成乙型脑炎病毒核酸检测试剂国家参考品,经多家实验室的协助标定,确定参考品的质量标准,并对参考品进行均匀性及稳定性评估。结果乙型脑炎病毒核酸检测试剂国家参考品由10份阴性、14份阳性、1份最低检出限和1份精密度样品组成。质量标准为10份阴性参考品应均检出阴性;14份阳性参考品应至少检出13份阳性;精密度考品重复检测10次,要求均为乙型脑炎病毒阳性,且其检测值的CV应不大于5.0%;最低检出限参考品要求1∶102倍稀释及以上浓度时应为乙型脑炎病毒阳性。参考品的均匀性及稳定性均符合要求。结论该参考品可用作乙型脑炎病毒核酸检测试剂的质量控制及评价。
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.
作者
夏德菊
周海卫
刘东来
许四宏
XIA Deju;ZHOU Haiwei;LIU Donglai;XU Sihong(DivisionⅡof Diagnostic for Infectious Diseases,National Institutes of Food and Drug Control,Beijing,China,100050)
出处
《分子诊断与治疗杂志》
2024年第5期796-799,803,共5页
Journal of Molecular Diagnostics and Therapy
基金
国家重点研发计划项目(2018ZX10102001)。
关键词
乙型脑炎病毒
核酸检测试剂
基因分型
国家参考品
Japanese encephalitis virus
Nucleic acid testing reagents
Genotyping
National ref⁃erence