摘要
目的研制产气荚膜梭菌(CP)核酸检测试剂国家参考品。方法通过对5株产气荚膜梭菌和7株非产气荚膜梭菌的菌种检定、培养、灭活及分装,组建产气荚膜梭菌核酸检测试剂国家参考品。对参考品进行样品均匀性以及稳定性评估验证,组织3家实验室协作标定。结果参考品由5份阳性参考品、7份阴性参考品、3份重复性参考品以及1份最低检出限参考品样本组成,均匀性和稳定性良好。协作标定结果显示:5份阳性参考品检测结果均为产气荚膜梭菌阳性;7份阴性参考品检测结果均为产气荚膜梭菌阴性;重复性参考品检测结果全部为气荚膜梭菌阳性(n=10,CV≤5.00%);参考品最低检出限为1.0×10^(3)个菌/mL。结论建立了产气荚膜梭菌核酸检测试剂国家参考品,建立的国家参考品可用于产气荚膜梭菌核酸检测试剂盒的质量控制。
Objective To develop a national reference for nucleic acid detection kits of Clostridium perfringens(CP).Methods Five strains of Clostridium perfringens and 7 strains of non-Clostridium perfringens were tested,cultured,inactivated and prepared to establish a national reference for nucleic acid detection kits of Clostridium perfringens.The uniformity and stability of reference were evaluated and verified,and collaborative calibration involving 3 laboratories was organized.Results The reference was composed of 5 positive reference samples,7 negative reference samples,3 repeatable reference samples and 1 minimum detection limit reference sample,with good uniformity and stability.The results of collaborative calibration showed that all the 5 positive reference samples were CP positive,all the 7 negative reference samples were CP negative,the minimum detection limit of reference was 1.0×10^(3) bacterias/mL.The results of repeatable reference were all CP positive(n=10,CV≤5.00%).Conclusion A national reference for nucleic acid detection kits of Clostridium perfringens is established and can be used for quality control of nucleic acid detection kits for Clostridium perfringens.
作者
刘茹凤
陈驰
石继春
李康
王斌
王春娥
叶强
李茂光
LIU Rufeng;CHEN Chi;SHI Jichun;LI Kang;WANG Bin;WANG Chune;YE Qiang;LI Maoguang(Division of Bacterial Polysaccharide and Conjugat Vaccines,Institut for Biological Product Control,National Institutes for Food and Drug Control,Beijing 102629,China)
出处
《国际检验医学杂志》
CAS
2023年第S01期10-13,共4页
International Journal of Laboratory Medicine
基金
国家科技重大专项课题(2018ZX10102-001-002、2018ZX09738006-006)
国家科技基础条件平台-国家菌种资源库课题(NMRC-2020-2)。
关键词
产气荚膜梭菌
核酸检测
验证
国家参考品
Clostridium perfringens
nucleic acid detection
validation
national reference
