新型冠状病毒血清学抗体检测试剂盒现状分析

罗雪莲 闫梅英 吴媛 戴琰 程雁鹏 徐建国

罗雪莲, 闫梅英, 吴媛, 戴琰, 程雁鹏, 徐建国. 新型冠状病毒血清学抗体检测试剂盒现状分析[J]. 疾病监测, 2021, 36(1): 29-36. doi: 10.3784/jbjc.202011230392
引用本文: 罗雪莲, 闫梅英, 吴媛, 戴琰, 程雁鹏, 徐建国. 新型冠状病毒血清学抗体检测试剂盒现状分析[J]. 疾病监测, 2021, 36(1): 29-36. doi: 10.3784/jbjc.202011230392
Luo Xuelian, Yan Meiying, Wu Yuan, Dai Yan, Cheng Yanpeng, Xu Jianguo. Current status of antibody detection kits for SARS-CoV-2[J]. Disease Surveillance, 2021, 36(1): 29-36. doi: 10.3784/jbjc.202011230392
Citation: Luo Xuelian, Yan Meiying, Wu Yuan, Dai Yan, Cheng Yanpeng, Xu Jianguo. Current status of antibody detection kits for SARS-CoV-2[J]. Disease Surveillance, 2021, 36(1): 29-36. doi: 10.3784/jbjc.202011230392

新型冠状病毒血清学抗体检测试剂盒现状分析

doi: 10.3784/jbjc.202011230392
基金项目: 国家自然科学基金(No. 81802017)
详细信息
    作者简介:

    罗雪莲,女,湖北省荆门市人,博士,副研究员,主要从事新发病原体的分离鉴定及遗传进化研究,Email:luoxuelian@icdc.cn

    通讯作者:

    徐建国,Tel:010–58900701,Email:xujianguo@icdc.cn

  • 中图分类号: R211;R373

Current status of antibody detection kits for SARS-CoV-2

Funds: This study was supported by National Natural Science Foundation of China (No. 81802017)
More Information
  • 摘要: 血清特异性抗体检测是诊断新型冠状病毒(SARS-CoV-2)感染的重要工具。 然而在短时间内大量SARS-CoV-2血清学抗体检测试剂盒紧急上市,其准确性和有效性存在很大不确定性。 本研究对国内外SARS-CoV-2血清学抗体检测试剂盒现状做简要综述,为医院和疾控人员的使用提供参考。
  • 图  1  已批准新型冠状病毒抗体检测试剂盒的检测方法(A)及检测抗体类型(B)

    Figure  1.  Methods(A)and antibody types(B)of approved antibody detection kits for SARS-CoV-2

    表  1  美国食品药品监督管理局紧急批准的新型冠状病毒抗体检测试剂盒

    Table  1.   Antibody detection kits for SARS-CoV-2 authorized by FDA, US

    编号公司名称试剂盒名称靶向蛋白检测抗体类型/检测方法
    1Abbott Laboratories Inc.AdviseDx SARS-CoV-2 IgMSIgM, CMIA
    2Beckman Coulter, Inc.Access SARS-CoV-2 IgMSIgM, CLIA
    3Genalyte, Inc.Maverick SARS-CoV-2 Multi-Antigen
    Serology Panel v2
    S and NTotal Antibody, photonic ring immunoassay
    4Thermo Fisher ScientificOmniPATH COVID-19 Total Antibody
    ELISA Test
    STotal Antibody, ELISA
    5ZEUS Scientific, Inc.ZEUS ELISA SARS-CoV-2 IgG Test SystemSIgG, ELISA
    6DiaSorin, Inc.DiaSorin LIAISON SARS-CoV-2 IgM AssaySIgM, Indirect CLIA
    7NanoEntek America, Inc.FREND COVID-19 total AbNTotal Antibody, FIA
    8Nirmidas Biotech, Inc.Nirmidas COVID-19(SARS-CoV-2)
    IgM/IgG Antibody Detection Kit
    SIgM and IgG, Lateral Flow
    9Quotient Suisse SAMosaiQ COVID-19 Antibody MagazineSTotal Antibody, photometric immunoassay
    10Assure Tech.(Hangzhou Co., Ltd)Assure COVID-19 IgG/IgM
    Rapid Test Device
    S and NIgM and IgG, Lateral Flow
    11aJiangsu Well Biotech Co., Ltd.Orawell IgM/IgG Rapid TestSIgM and IgG, Lateral Flow
    12Abbott Laboratories Inc.SARS-CoV-2 IgG assaySIgG, CMIA
    13aShenzhen New Industries Biomedical Engineering Co., Ltd.MAGLUMI 2019-nCoV IgM/IgGS and NIgM and IgG, CLIA
    14BioCheck, Inc.BioCheck SARS-CoV-2 IgM Antibody Test KitSIgM, CLIA
    15BioCheck, Inc.BioCheck SARS-CoV-2 IgG Antibody Test KitSIgG, CLIA
    16Sugentech, Inc.SGTi-flex COVID-19 IgGS and NIgG, Lateral Flow
    17aHangzhou Biotest Biotech Co., Ltd.RightSign COVID-19 IgG/IgM Rapid Test CassetteSIgM and IgG Lateral Flow
    18TBG Biotechnology Corp.TBG SARS-CoV-2 IgG / IgM Rapid Test KitS and NIgM and IgG, Lateral Flow
    19University of Arizona Genetics Core for Clinical ServicesCOVID-19 ELISA pan-Ig Antibody TestSTotal Antibody, ELISA
    20Biocan Diagnostics Inc.Tell Me Fast Novel Coronavirus(COVID-19)IgG/IgM Antibody Test - Letter of AuthorizationS and NIgM and IgG/Lateral Flow
    21BioCheck, Inc.BioCheck SARS-CoV-2 IgG and IgM Combo TestSIgM and IgG/CLIA
    22Diazyme Laboratories, Inc.Diazyme DZ-Lite SARS-CoV-2 IgM CLIA KitS and NIgM/CLIA
    23aHangzhou Laihe Biotech Co., Ltd.LYHER Novel Coronavirus(2019-nCoV)IgM/IgG Antibody Combo Test Kit(Colloidal Gold)SIgM and IgG/Lateral Flow
    24Siemens Healthcare Diagnostics Inc.Dimension Vista SARS-CoV-2 Total antibody assay(COV2T)STotal Antibody/CLIA
    25Siemens Healthcare Diagnostics Inc.Dimension EXL SARS-CoV-2 Total antibody assay(CV2T)STotal Antibody/CLIA
    26bioMérieux SAVIDAS SARS-CoV-2 IgMSIgM/ELFA
    27bioMérieux SAVIDAS SARS-CoV-2 IgGSIgG/ELFA
    28aBeijing Wantai Biological Pharmacy Enterprise Co., Ltd.WANTAI SARS-CoV-2 Ab ELISASTotal Antibody/ELISA
    29Biohit Healthcare(Hefei)Co. Ltd.Biohit SARS-CoV-2 IgM/IgG Antibody Test KitNIgM and IgG/Lateral Flow
    30Siemens Healthcare Diagnostics Inc.Atellica IM SARS-CoV-2 IgG(COV2G)SIgG/ELISA
    31Siemens Healthcare Diagnostics Inc.ADVIA Centaur SARS-CoV-2 IgG(COV2G)SIgG/ELISA
    32aXiamen Biotime Biotechnology Co., Ltd.BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative TestSIgM and IgG/Lateral Flow
    33Access Bio, Inc.CareStart COVID-19 IgM/IgGS and NIgM and IgG/Lateral Flow
    34DiaSorin Inc.LIAISON SARS-CoV-2 S1/S2 IgGSIgG/CLIA
    35Bio-Rad Laboratories, Inc.Platelia SARS-CoV-2 Total Ab assayNTotal Antibody/ELISA
    36Roche DiagnosticsElecsys Anti-SARS-CoV-2NTotal Antibody/ECLIA
    37Megna Health, Inc.Rapid COVID-19 IgM/IgG Combo Test KitNIgM and IgG/Lateral Flow
    38Luminex CorporationxMAP SARS-CoV-2 Multi-Antigen IgG AssayS and NIgG/FMIA
    39Salofa OySienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test CassetteSIgM and IgG/Lateral Flow
    40aBeijing Wantai Biological Pharmacy Enterprise Co., Ltd.WANTAI SARS-CoV-2 Ab Rapid TestSTotal Antibody/Lateral Flow
    41Diazyme Laboratories, Inc.Diazyme DZ-Lite SARS-CoV-2 IgG CLIA KitS and NIgG/CLIA
    42InBios International, Inc.SCoV-2 Detect IgM ELISASIgM/ELISA
    43Beckman Coulter, Inc.Access SARS-CoV-2 IgGSIgG/CLIA
    44Babson Diagnostics, Inc.Babson Diagnostics aC19G1SIgG/CLIA
    45Emory Medical LaboratoriesSARS-CoV-2 RBD IgG testSIgG/ELISA
    46Cellex Inc.qSARS-CoV-2 IgG/IgM Rapid TestS and NIgM and IgG/Lateral Flow
    47InBios International, Inc.SCoV-2 Detect IgG ELISASIgG/ ELISA
    48Vibrant America Clinical LabsVibrant COVID-19 Ab AssayS and NIgM and IgG/CLIA
    49Healgen Scientific LLCCOVID-19 IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma)SIgM and IgG/Lateral Flow
    50Siemens Healthcare Diagnostics Inc.Atellica IM SARS-CoV-2 Total(COV2T)STotal Antibody/CLIA
    51Siemens Healthcare Diagnostics Inc.ADVIA Centaur SARS-CoV-2 Total(COV2T)STotal Antibody/CLIA
    52EUROIMMUN US Inc.Anti-SARS-CoV-2 ELISA(IgG)SIgG/ELISA
    53Wadsworth left, New York State Department of HealthNew York SARS-CoV Microsphere Immunoassay for Antibody DetectionNTotal Antibody/FMIA
    54Ortho Clinical Diagnostics, Inc.VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent PackSTotal Antibody/CLIA
    55Ortho-Clinical Diagnostics, Inc.VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent PackSIgG/CLIA
    56Mount Sinai LaboratoryCOVID-19 ELISA IgG Antibody TestSIgG/ELISA
      注:a. 中国公司研发生产的试剂盒;CMIA. chemiluminescent microparticle immunoassay; CLIA. chemiluminescent immunoassays; ELISA. enzyme-linked immunosorbent assay; FIA. fluorescent immunoassay; ELFA. enzyme-linked fluorescence assay; ECLIA. electrochemiluminescence immunoassay; FMIA. fluorescent microsphere immunoassay
    下载: 导出CSV

    表  2  中国国家药品监督管理局批准的新型冠状病毒抗体检测试剂盒

    Table  2.   Antibody detection kits for SARS-CoV-2 authorized by National Medical Products Administration, China

    编号公司名称试剂盒名称检测抗体类型/检测方法注册编号
    1珠海经济特区海泰生物制药有限公司新型冠状病毒N-蛋白检测试剂盒IgG/酶联免疫吸附法国械注准20173401143
    2博奥赛斯(天津)生物科技有限公司新型冠状病毒(2019-nCoV)IgM抗体检测试剂盒IgM/化学发光免疫分析法国械注准20203400499
    3博奥赛斯(天津)生物科技有限公司新型冠状病毒(2019-nCoV)IgG抗体检测试剂盒IgG/化学发光免疫分析法国械注准20203400498
    4北京新兴四寰生物技术有限公司新型冠状病毒(2019-nCoV)IgM抗体检测试剂盒IgM/胶体金法国械注准20203400457
    5珠海丽珠试剂股份有限公司新型冠状病毒(2019-nCoV)IgM/IgG抗体检测试剂盒IgG/IgM/胶体金法国械注准20203400240
    6上海芯超生物科技有限公司新型冠状病毒(2019-nCoV)
    抗体检测试剂盒
    胶体金法国械注准20203400367
    7广州万孚生物技术股份有限公司新型冠状病毒(2019-nCoV)
    抗体检测试剂盒
    胶体金法国械注准20203400176
    8英诺特(唐山)生物技术有限公司新型冠状病毒(2019-nCoV)
    IgM/IgG抗体检测试剂盒
    IgM/IgG/胶体金法国械注准20203400177
    9南京诺唯赞医疗科技有限公司新型冠状病毒(2019-nCoV)
    IgM / IgG抗体检测试剂盒
    IgM/IgG/胶体金法国械注准20203400239
    10广东和信健康科技有限公司新型冠状病毒(2019-nCoV)IgM抗体检测试剂盒IgM/胶体金法国械注准20203400199
    11迈克生物股份有限公司新型冠状病毒(2019-nCoV)IgM抗体检测试剂盒IgM/化学发光免疫分析法国械注准20203400497
    12迈克生物股份有限公司新型冠状病毒(2019-nCoV)IgG抗体检测试剂盒IgG/化学发光免疫分析法国械注准20203400496
    13北京热景生物技术股份有限公司新型冠状病毒(2019-nCoV)
    抗体检测试剂盒
    上转发光免疫层析法国械注准20203400523
    14郑州安图生物工程股份有限公司新型冠状病毒(2019-nCoV)IgM抗体检测试剂盒IgM/磁微粒化学发光免疫分析法国械注准20203400494
    15郑州安图生物工程股份有限公司新型冠状病毒(2019-nCoV)IgG抗体检测试剂盒IgG/磁微粒化学发光免疫分析法国械注准20203400495
    16丹娜(天津)生物科技有限公司新型冠状病毒(2019-nCoV)IgG抗体检测试剂盒IgG/磁微粒化学发光免疫分析法国械注准20203400365
    17丹娜(天津)生物科技有限公司新型冠状病毒(2019-nCoV)IgM抗体检测试剂盒IgM/磁微粒化学发光免疫分析法国械注准20203400366
    18博奥赛斯(重庆)生物科技有限公司新型冠状病毒(2019-nCoV)IgM抗体检测试剂盒IgM/磁微粒化学发光免疫分析法国械注准20203400182
    19博奥赛斯(重庆)生物科技有限公司新型冠状病毒(2019-nCoV)IgG抗体检测试剂盒IgG/磁微粒化学发光免疫分析法国械注准20203400183
    20北京金豪制药股份有限公司新型冠状病毒(2019-nCoV)IgM/IgG抗体检测试剂盒IgM/IgG量子点荧光免疫层析法国械注准20203400536
    21北京华大吉比爱生物技术有限公司新型冠状病毒(2019-nCoV)IgM/IgG抗体检测试剂盒IgM/IgG酶联免疫吸附法国械注准20203400567
    22厦门万泰凯瑞生物技术有限公司新型冠状病毒(2019-nCoV)
    抗体检测试剂盒
    磁微粒化学发光免疫分析法国械注准20203400198
    下载: 导出CSV
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  • 收稿日期:  2020-11-23
  • 网络出版日期:  2020-01-12
  • 刊出日期:  2021-02-08

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