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新型冠状病毒核酸检测方法及标准物质的研究进展

赵雨佳 廖湉毅 范培蕾 梁亮 赵海波 沈正生

赵雨佳,廖湉毅,范培蕾,等. 新型冠状病毒核酸检测方法及标准物质的研究进展[J]. 计量科学与技术,待出版. doi: 10.12338/j.issn.2096-9015.2020.0375
引用本文: 赵雨佳,廖湉毅,范培蕾,等. 新型冠状病毒核酸检测方法及标准物质的研究进展[J]. 计量科学与技术,待出版. doi: 10.12338/j.issn.2096-9015.2020.0375
ZHAO Yujia, LIAO Tianyi, FAN Peilei, LIANG Liang, ZHAO Haibo, Shen Zhengsheng. Perspective on 2019-nCoV Detection and Reference Materials[J]. Metrology Science and Technology. doi: 10.12338/j.issn.2096-9015.2020.0375
Citation: ZHAO Yujia, LIAO Tianyi, FAN Peilei, LIANG Liang, ZHAO Haibo, Shen Zhengsheng. Perspective on 2019-nCoV Detection and Reference Materials[J]. Metrology Science and Technology. doi: 10.12338/j.issn.2096-9015.2020.0375

新型冠状病毒核酸检测方法及标准物质的研究进展

doi: 10.12338/j.issn.2096-9015.2020.0375
基金项目: 国家重点研发计划(2019YFF0216703);第66批中国博士后科学基金(2019M660539)。
详细信息
    作者简介:

    赵雨佳(1989-),北京市计量检测科学研究院博士后,研究方向:核酸计量、病原微生物检测方法等,邮箱:zhaoyj@bjjl.cn;通讯作者:

    沈正生(1961-),北京市计量检测科学研究院教授级高工,研究方向:化学计量,邮箱:shenzs@bjjl.cn

Perspective on 2019-nCoV Detection and Reference Materials

  • 摘要: 新型冠状病毒(SARS-CoV-2)具有很强的传染能力,已造成全球大流行,对人类健康和社会的经济发展造成极大影响。快速、准确的检测新型冠状病毒对病情的确诊和疫情的防控尤为重要。我国国家市场监督管理总局已注册22种新型冠状病毒核酸检测试剂盒,能满足对高危人群的大规模筛查,有力保障疫情防控。同时,中国计量科学研究院研制的新型冠状病毒标准物质作为计量实体,进一步保障检测结果的准确性和溯源性。通过对国家食品药品监督管理局和国家标准物质资源共享平台公布的数据进行分析和梳理,结合国内外相关研究进展,就新型冠状病毒的检测方法、检测试剂盒及标准物质进行综述,以期为新型冠状病毒及其他传染性疾病的诊断和防控提供借鉴和参考思路。
  • 图  1  新型冠状病毒的核酸检测流程

    Figure  1.  The workflow of SARS-CoV-2 detection

    图  2  LAMP扩增示意图[22]

    Figure  2.  The schematic diagram of LAMP[22]

    表  1  CFDA注册的新型冠状病毒核酸检测试剂盒

    Table  1.   The registration 2019-nCoV detection kit of CFDA

    序号名称注册证编号适用范围
    1新型冠状病毒2019-nCoV核酸分析软件20203210062核酸检测分析软件
    2新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)20203400520ORF1ab和N基因
    3新型冠状病毒(2019-nCoV)核酸检测试剂盒(荧光PCR法)20203400299ORF1ab和N基因、E基因
    4新型冠状病毒2019-nCoV核酸检测试剂盒(双扩增法)20203400302ORF1ab和E基因
    5新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)20203400322ORF1ab基因、N基因
    6新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)20203400384ORF1ab和N基因
    7新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)20203400065ORF1ab和N基因
    8新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)20203400057ORF1ab和N基因、E基因
    9新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)20203400060ORF1ab基因
    10新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)20203400184ORF1ab、N基因和E基因
    11新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)20203400058ORF1ab和N基因
    12新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)20203400644ORF1ab和N 基因
    13新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)20203400064ORF1ab和N基因
    14新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)20203400063ORF1ab和N基因
    15新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)20203400537ORF1ab基因和N基因
    16新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)20203400179ORF1ab、N基因和E基因
    17新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)20203400535ORF1ab基因
    18新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)20203400212ORF1ab基因、N基因
    19新型冠状病毒2019-nCoV核酸检测试剂盒(RNA捕获探针法)20203400300ORF1ab基因
    20新型冠状病毒2019-nCoV核酸检测试剂盒(RNA恒温扩增-金探针层析法)20203400301ORF1ab和E基因
    21新型冠状病毒2019-nCoV核酸检测试剂盒(联合探针锚定聚合测序法)20203400059核酸序列
    22新型冠状病毒2019-nCoV核酸检测试剂盒(恒温扩增-实时荧光法)20203400241ORF1ab基因、N基因
    下载: 导出CSV

    表  2  新型冠状病毒的国家有证核酸标准物质

    Table  2.   The certified nucleic acid reference materials of SARS-CoV-2

    序号标物名称编号标准值定值方法
    1新型冠状病毒核酸标准物质(高浓度)GBW(E)091089E基因(7.05±0.54)×105 copy/μL数字PCR
    ORF1ab(1.10±0.12)×106 copy/μL
    N基因(8.38±0.76)×105 copy/μL
    2新型冠状病毒核酸标准物质(低浓度)GBW(E)091090E基因(7.63±0.66)×102 copy/μL数字PCR
    ORF1ab(1.24±0.19)×103 copy/μL
    N基因(9.8±1.2)×102 copy/μL
    3新型冠状病毒核糖核酸基因组标准物质GBW(E)091098E基因(1.29±0.26)×102 copy/μL数字PCR
    ORF1ab(9.5±1.8)×103 copy/μL
    N基因(2.05±0.31)×102 copy/μL
    4新型冠状病毒核糖核酸基因组标准物质GBW(E)091099E基因(1.06±0.11)×103 copy/μL数字PCR
    ORF1ab(8.96±0.61)×102 copy/μL
    N基因(1.73±0.13)×103 copy/μL
    5新型冠状病毒体外转录RNA标准物质GBW(E)091111E基因(2.0±0.3)×105 copy/μL数字PCR
    ORF1ab(1.2±0.2)×105 copy/μL
    N基因(1.0±0.1)×106 copy/μL
    6新型冠状病毒体外转录RNA标准物质GBW(E)091112E基因(2.0±0.3)×107 copy/μL数字PCR
    ORF1ab(1.2±0.2)×107 copy/μL
    N基因(1.0±0.1)×108 copy/μL
    7新型冠状病毒(2019-nCoV)假病毒核糖核酸标准物质NIM-RM5203E基因(4.6±0.9)×102 copy/μL数字PCR
    ORF1ab(6.5±1.2)×102 copy/μL
    N基因(4.3±0.9)×102 copy/μL
    下载: 导出CSV
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  • 网络出版日期:  2021-11-19

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