[1]张园,周泽奇,王志贤,等.新型冠状病毒核酸、抗原和抗体联合检测的临床价值讨论[J].现代检验医学杂志,2020,35(05):99-102,109.[doi:10.3969/j.issn.1671-7414.2020.05.025]
　ZHANG Yuan,ZHOU Ze-qi,WANG Zhi-xian,et al.Discussion on the Clinical Value of Combined Detection of SARS-CoV-2 Nucleic Acid，Antigen and Antibody[J].Journal of Modern Laboratory Medicine,2020,35(05):99-102,109.[doi:10.3969/j.issn.1671-7414.2020.05.025]
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新型冠状病毒核酸、抗原和抗体联合检测的临床价值讨论()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第35卷
期数:
2020年05期
页码:
99-102,109
栏目:
新型冠状病毒肺炎检验专题
出版日期:
2020-11-01

文章信息/Info

Title:
Discussion on the Clinical Value of Combined Detection of SARS-CoV-2 Nucleic Acid，Antigen and Antibody
文章编号:
1671-7414（2020）05-099-05
作者:
张园1; 周泽奇1; 王志贤1; 粟艳1; 肖盟2; 3; 徐英春2; 3; 王贺1
1.“侵袭性真菌病机制研究与精准诊断”北京市重点实验室丹娜生物分中心，天津 300467；2. 中国医学科 学院北京协和医院检验科，北京100730；3.“侵袭性真菌病机制研究与精准诊断”北京市 重点实验室（BZ0447），北京100730
Author(s):
ZHANG Yuan1;  ZHOU Ze-qi1;  WANG Zhi-xian1;  SU Yan1;  XIAO Meng2; 3;  XU Ying-chun2; 3 ;  WANG He1
1.Dynamiker Sub-Center for Beijing Key Laboratory for Mechanisms Research and Precision Diagnosis of Invasive Fungal Disease, Tianjin 300467, China; 2.Department of Laboratory Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences,Beijing 100730, China; 3. Beijing Key Laboratory for Mechanisms Research and Precision Diagnosis of Invasive Fungal Diseases (BZ0447), Beijing 100730, China
关键词:
新型冠状病毒; 新型冠状病毒肺炎; 核酸; 抗原; 抗体; 联合检测
分类号:
R195
DOI:
10.3969/j.issn.1671-7414.2020.05.025
文献标志码:
A
摘要:
新型冠状病毒（SARS-CoV-2）核酸检测是金标准，抗原抗体检测是核酸检测的重要辅助手段。核酸与抗原检 测是患者早期感染的直接证据，但不能提示患者是否既往感染。抗体检测是患者感染的间接证据，IgM 阳性提示急性感 染，IgG 阳性提示病情中后期或既往感染。同时，抗体检测可作为评价疫苗与抗体治疗药物临床效果的重要指标。虽然 抗原检测可作为早期诊断的直接证据，但灵敏度不高，尚未获得认可。因此，核酸、抗原和抗体联合检测能提高临床检 测的敏感度和特异度，为复工、复产提供重要依据。
Abstract:
Novel coronavirus (SARS-CoV-2) nucleic acid detection is a gold standard. Antigen and antibody tests can be used as an aid for nucleic acid assay. Both nucleic acid and antigen detections are known as a direct evidence for the early infection, but they could not identify patients whether or not have a previous infection. Antibody testing is indirect evidence of patient infection. Positive IgM indicates acute infection, and IgG positive indicates previous infection. Simultaneously, 阿ntibody testing can be used as an important indicator to evaluate the clinical effects of vaccines and antibody therapeutics.Although antigen detection can be used as direct evidence for early diagnosis, the sensitivity is not high and has not yet been recognized. Therefore, the panel testing for nucleic acid/antigen/antibody can improve the sensitivity and specificity of clinical detection and provide an important basis for resuming work and resuming production.

参考文献/References:

[1] ORAN D P, TOPOL E J. Getting a handle on asymptomatic SARS-CoV-2 infection[EB/OL]. [ 2020- 04-24].https://www.scripps.edu/science-and-medicine/ translational-institute/about/news/sarc-cov-2-infection/ index.html.
[2] BAI Yan, YAO Lingsheng, WEI Tao, et al. Presumed asymptomatic carrier transmission of COVID-19 [J]. JAMA, 2020.DOI:10.1001/jama.2020.2565.
[3] CORMAN VICTOR M, LANDT O, KAISER M, et al. Detection of 2019 novel coronavirus (2019- nCoV) by real-time RT-PCR[J]. Euro Surveill, 2020,25(3):2000045.
[4] 中华人民共和国国家卫生健康委员会. 国卫办疾控 函（2020）80 号：新型冠状病毒感染的肺炎实验室 检测技术指南( 第三版)[EB/OL].(2020-01-28)http:// www.nhc.gov.cn/xcs/zhengcwj/202001/f492c9153ea94 37bb587ce2ffcbee1fa/files/39e7578d85964dbe8111773 6dd789d8f.pdf. General Office for National Health Commission and National Administration of Traditional Chinese Medicine. CDC Letter(2020)NO 80：2019 novel coronavirus (2019-nCoV) Infection Laboratory Testing Technical Guide[EB/OL].(2020-01-28)http://www.nhc.gov.cn/xcs/ zhengcwj/202001/f492c9153ea9437bb587ce2ffcbee1fa/fil es/39e7578d85964dbe81117736dd789d8f.pdf.
[5] 中华医学会检验学分会. 新型冠状病毒肺炎病毒 核酸检测专家共识[J/OL]. 中华医学杂志,2020,100 （13）:968-973. Laboratory Medicine Branch of Chinese Medical Association. Expert consensus on NUCLEic acid testing for COVID-19 virus[J/OL]. National Medical Journal of China, 2020,100（13）: 968-973.
[6] 马红霞, 潘静静, 李懿, 等. 实时荧光RT-PCR 方法 检测新型冠状病毒核酸结果分析 [J]. 中华微生物学 和免疫学杂志,2020,40 (4): 245-249. MA Hongxia, PAN Jingjing, LI Yi, et al. Real-time RT-PCR for the detection of SARS-CoV-2 nucleic acid [J] . Chin J Microbiol Immunol, 2020,40(4): 245-249.
[7] 王晟, 刘兴态, 秦军, 等. 738 例新型冠状病毒肺炎 病例密切接触者核酸筛查结果分析[J]. 中国感染控 制杂志，2020,19（4）: 297-300. WANG Sheng，LIU Xingtai，QIN Jun，et al.Nucleic acid screening results of 738 close contacts of coronavirus disease 2019[J].Chinese Journal of Infection Control， 2020,19（4）: 297-300.
[8] 苑伟, 陈相军, 黄应德, 等. 某大型综合医院发热门 诊1 770 例发热患者临床资料分析[J]. 中国感染控 制杂志, 2020,19(3): 277-280. YUAN Wei，CHEN Xiangjun，HUANG Yingde，et al.Clinical data of 1 770 patients with fever in the fever clinic of a large general hospital [J].Chinese Journal of Infection Control, 2020,19(3): 277-280.
[9] 李彩玉, 陈梦媛, 张师音, 等. 新型冠状病毒核酸检 测“假阴性”原因分析及控制要点[J]. 厦门大学学 报( 自然科学版) , 2020 , 59 ( 3 ): 310-316. LI Caiyu , CHEN Mengyuan , ZHANG Shiyin , et al. Cause analysis and control points of false negative nucleic acid test for severe acute respiratory syndrome coronavirus 2 [J]. Journal of Xiamen University （Nat Sci）, 2020 , 59 ( 3 ): 310-316.
[10] LI Xiaowei, GENG Manman, PENG Yizhao et al. Molecular immune pathogenesis and diagnosis of COVID-19[J] Journal of Pharmaceutical Analysis, 2020, 10（2）:102-108.
[11] YANG Yang, YANG Minghui, SHEN Chenguang, et al. Evaluating the accuracy of differentrespiratory specimens in the laboratory diagnosis and monitoring the viralshedding of 2019-nCoV infections [J]. medRxiv, 2020. DOI: https://doi.org/10.1101/2020.0 2.11.20021493.
[12] ZHAO Juanjuan, YUAN Quan, WANG Haiyan, et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019 [J]. Clin Infect Dis, 2020. DOI:10.1093/cid/ciaa344.
[13] LI Zhengtu，YI Yongxiang，LUO Xiaomei, et al. Development and clinical application of A rapid IgMIgG combined antibody test for SARS-CoV-2 Infection Diagnosis[J]. J Med Virol, 2020, 92（9）: 25727.
[14] ZHANG Bicheng, ZHOU Xiaoyang, ZHU Chengliang, et al. Immune phenotyping based on the neutrophil-to-lymphocyte ratio and IgG level predicts disease severity and outcome for patients with COVID-19[J]. medRxiv, 2020, 7:157.
[15] HALSTEAD S B, MAHALINGAM S, MAROVICH M A, et al. Intrinsic antibody-dependent enhancement of microbial infection in macrophages: disease regulation by immune complexes [J]. Lancet Infect Dis,. 2010, 10(10):712-722.
[16] LIDBURY B A, MAHALINGAM S. Specific ablation of antiviral gene expression in macrophages by antibody-dependent enhancement of Ross River virus infection [J]. J Virol, 2000, 74(18):8376-8381.
[17] WANG Bin, WANG Li, KONG Xianggen, et al. Long-term coexistence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with antibody response in coronavirus disease 2019 (COVID-19) patients[J]. medRxiv, 2020 .DOI: https://doi.org/10.1101/2020.04.13.20040980.
[18] WU Fan, WANG Aojie, LIU Mei, et al.Neutralizing antibody responses to SARS-CoV-2 in a COVID-19 recovered patient cohort and their implications [J]. medRxiv, 2020. DOI: https://doi.org/10.1101/2020.03.30.20047365.
[19] 徐万洲, 李娟, 何晓云, 等. 血清2019 新型冠状病毒 IgM 和IgG 抗体联合检测在新型冠状病毒感染中的 诊断价值 [J/OL]. 中华检验医学杂志,2020,43(2020-02- 27).DOI: 10.3760/cma.j.cn114452-20200223-00109. XU Wanzhou , LI Juan, HE Xiaoyun, et al. The diagnostic value of joint detection of serum IgMand IgG antibodies to 2019-nCoV in 2019-nCoV infection[J/OL].Chin J Lab Med, 2020,43(2020-02-27). DOI: 10.3760/cma.j.cn114452-20200223-00109.
[20] 李闻，郑宝璐，于爱萍，等. 新型冠状病毒IgM/ IgG 抗体病程监测中的临床意义[J] 临床检验杂志， 2020,38（6）：401-404. LI Wen,ZHENG Baolu,Yu Aiping,etal,Clinical significance of SARS-Cov-z IgM/IgG antibodies in monitoring of COVID-19[J].Chinese Journal of Clinical Laboratory Science,2020,38(6):401-404.
[21] World Health Organization. Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases[EB/OL].(2020-01-14).https://www.who.int/ publications/i/item/laboratory-testing-for-2019-novelcoronavirus- in-suspected-human-cases-20200117.
[22] 黄亚兰, 孟君, 孙颖, 等. 新型冠状病毒肺炎患者住 院时间和病程的影响因素分析[J/OL]. 热带医学杂 志，2020. http://kns.cnki.net/kcms/detail/44.1503.r.20 200403.1532.002.html. HUANG Yalan, MENG Jun, SUN Ying ,et al. Influencing factors of virus clearance of COVID-19 patients[J/ OL].Journal of Tropical Medicine，2020. http://kns. cnki.net/kcms/detail/44.1503.r.20200403.1532.002. html .
[23] 李萍, 李志勇, 赵四林, 等. 血清2019-nCoV IgM 和 IgG 抗体用于诊断新型冠状病毒肺炎的初探 [J] . 中 华检验医学杂志,2020,43 (4): 352-357. LI Ping, LI Zhiyong, ZHAO Silin, et al. Preliminary study of serum 2019-nCoV IgM and IgG antibodies in the diagnosis of COVID-19 [J] .Chin J Lab Med, 2020,43(4): 352-357.

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备注/Memo

备注/Memo:
基金项目： 1. 国家科技重大专项“艾滋病和病毒性肝炎等重大传染病防治”课题（编号2020ZX101015）；2. 天津市重大科技专项“新型 冠状病毒感染应急防治”课题（编号20ZXGBSY00040）；3. 天津市科技计划“侵袭性真菌病新型体外诊断试剂及POCT 自动化 检验分析仪的研发”课题（编号：2020ZX101015）；4. 中国博士后科学基金“基于假病毒技术的新型冠状病毒中和抗体检测模 型的建立及临床应用价值”课题（编号2020T1300011ZX）。
作者简介：张园（1978-），
更新日期/Last Update: 2020-10-30