首页|新型冠状病毒S蛋白Del 143~145突变核酸标准物质的制备及定值研究

新型冠状病毒S蛋白Del 143~145突变核酸标准物质的制备及定值研究

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目的 研制新型冠状病毒S蛋白Del143~145突变位点假病毒核糖核酸标准物质,满足公共卫生检测领域对标准物质的需求.方法 以新冠病毒原始株序列为参考,引入Omicron变异株特征性S蛋白Del 143~145,使用三质粒慢病毒包装系统制备假病毒.对产物进行均匀性、长期稳定性和短期稳定性评价,多家实验室联合定值.结果 制备的假病毒标准物质均匀性良好,可在-40℃下长期保存6个月以上,在常温条件下稳定12 h以上.多家实验室联合确定标准物质量值为(1.37±0.24)× 104 copies/μL.结论 研究制备的标准物质均匀稳定,适用于相关实验室的量值传递;质量检定、质量控制等多个领域.
Development and quantification of nucleicacid reference material of SARS-CoV-2 S protein with Del 143-145 mutation
Objective To developed the pseudovirus carrying point mutation of Del143-145 in S protein of severe acute respiratory coronavirus 2(SARS-CoV-2)as a standard reference material(SRM)of nucleic acid,so as to meet the needs of SRM in public health practice.Methods The Del143-145 in S protein as the characterized mutation of omicron variant was imported into the genome of original SARS-CoV-2 which was used as the reference genome.The pseudovirus was then prepared based on a three plasmids lentiviral packaging system.The homogeneity,long-term and short-term stability were tested,and the concentration was determined by multiple laboratories.Results The SRM showed good homogeneity which was stable for more than 6 months at-40℃ and for more than 12 hours at room temperature.Based on multiple laboratories calculation,the value of SRM was 1.37±0.24×104 copies/μL.Conclusions The SRM prepared in the study had good homogeneity and stability,and is suitable for multiple fields,including dissemination of values of quantity,verificatin of instruments and quality control.

Severe acute respiratory coronavirus 2LentivirusNucleic acid testStandard reference Material

梁志超、赵兴春、王晓文、徐雷、孟昊洋、鲁玺龙、赵洁、冯兆民、李夫、王全意、张代涛、杨扬仲夫、潘阳

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北京市疾病预防控制中心传染病地方病控制所 100013

公安部物证鉴定中心,北京 100038

中国计量测试学会行政审批部,北京 100125

北京睿信捷环保科技有限公司,北京 100010

北京市疾病预防控制中心中心办公室 100013

国家药品监督管理局药品审评中心生物制品临床部,北京 100176

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新型冠状病毒 慢病毒 核酸检测 标准物质

国家重点研发计划国家重点研发计划国家重点研发计划北京市科技计划

2023YFC30415002023YFC08724002023YFC 3041400-5Z231100004823002

2024

国际病毒学杂志
中华医学会,北京市疾病预防控制中心

国际病毒学杂志

CSTPCD北大核心
影响因子:1.826
ISSN:1673-4092
年,卷(期):2024.31(2)
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