[1]胡纪文,王恩运,阚丽娟,等.三种化学发光法检测新型冠状病毒(SARS-CoV-2)抗体试剂盒的临床应用评价[J].现代检验医学杂志,2020,35(04):100-105.[doi:10.3969/j.issn.1671-7414.2020.04.025]
 HU Ji-wen,WANG En-yun,KAN Li-juan,et al.Evaluation of Clinical Application of Three Chemiluminescence Detection Kits for Detection of Novel Coronavirus (SARS-CoV-2) Antibody[J].Journal of Modern Laboratory Medicine,2020,35(04):100-105.[doi:10.3969/j.issn.1671-7414.2020.04.025]
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三种化学发光法检测新型冠状病毒(SARS-CoV-2)抗体试剂盒的临床应用评价()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第35卷
期数:
2020年04期
页码:
100-105
栏目:
新型冠状病毒肺炎检验专题
出版日期:
2020-09-05

文章信息/Info

Title:
Evaluation of Clinical Application of Three Chemiluminescence Detection Kits for Detection of Novel Coronavirus (SARS-CoV-2) Antibody
文章编号:
1671-7414(2020)04-100-06
作者:
胡纪文王恩运阚丽娟豆小文赖柚霞徐 莎姜瑞伟张秀明
( 深圳市罗湖医院集团医学检验中心,广东深圳 518001)
Author(s):
HU Ji-wen WANG En-yun KAN Li-juan DOU Xiao-wen LAI You-xia XU Sha JIANG Rui-wei ZHANG Xiu-ming
(Medical Labouatory Center, Shenzhen Luohu Hospital Group, Guangdong Shenzhen 518001,China)
关键词:
新型冠状病毒化学发光免疫分析法抗体检测性能评价
分类号:
R373.19;R446
DOI:
10.3969/j.issn.1671-7414.2020.04.025
文献标志码:
A
摘要:
目的 评价三种新型冠状病毒(SARS-CoV-2)抗体化学发光试剂盒的检测性能,研究SARS-CoV-2 抗体检测的临床应用价值。方法 采用37 例临床确诊新型冠状病毒肺炎(COVID-19)患者恢复期血清样本和100 例对照患者血清样本,对三个不同厂家的化学发光新型冠状病毒抗体检测试剂盒进行评估。绘制ROC 曲线分析三种试剂的检测性能。利用Kappa 统计分析三种试剂的检测一致性。结果 对于IgM 抗体检测,试剂A 和试剂B 具有非常好的检测性能,尤其是试剂B 性能最优,临床敏感度为56.76%,临床特异度为99%;对于IgG 抗体检测,三种试剂均具有非常好的检测性能,三种试剂的临床特异度均为97.00%,而试剂C 的临床敏感度最高,为97.29%。对于IgM 抗体检测,试剂A 与试剂B 检测结果具有中度一致性(Kappa=0.508,P<0.05),试剂C 与试剂B 检测结果仅具有微弱一致性(Kappa=0.065,P ≥ 0.05);对于IgG 抗体检测,试剂A 与试剂C 检测结果具有高度一致性(Kappa=0.654,P<0.05),试剂A 与试剂B 检测结果为弱一致性(Kappa=0.102,P ≥ 0.05)。结论 三种化学发光法SARS-CoV-2 IgM 和IgG 抗体检测试剂盒均具有一定的临床敏感度和特异度,但各厂家产品的检出一致性相差较大,因此产品性能的标准化和工艺标准化亟待解决。

参考文献/References:

[1] ZHU Na, ZHANG Dingyu, WANG Wenling, et al. Anovel coronavirus from patients with pneumonia inChina, 2019[J]. the New England Journal of Medicine,2020, 382(8): 727-733.
[2] 中华人民共和国国家卫生健康委员会. (国卫办医函〔2020〕184 号): 关于印发新型冠状病毒感染的肺炎诊疗方案(试行第七版)的通知 [EB/OL].(2020-03-04). http://www.nhc.gov.cn/xcs/zhengcwj/202003/46c9294a7dfe4cef80dc7f5912eb1989.shtml. National Health Commission of the People’s Republicof China .Medical Letter of the State Health Office[2020] No. 187: Notification on the issuance ofCOVID-19 medical program (trial seventh edition) [EB/OL].(2020-03-04). http://www.nhc.gov.cn/xcs/zhengcwj/202003/46c9294a7dfe4cef80dc7f5912eb1989.shtml.
[3] GORBALENYA A E,BAKER S C, BARIC R S,et al. Severe acute respiratory syndrome-related coronavirus:The species and its viruses – a statement of theCoronavirus Study Group[J]. bioRxiv (2020-02-07)DOI: https://doi.org/10.1101/2020.02.07.937862.
[4] 李晖,李咏茵,张志高,等.2019 新型冠状病毒抗体胶体金检测方法的建立与临床性能评价[J].中华传染病杂志, 2020, 38(3): 139-144. LI Hui, LI Yongyin, ZHANG Zhigao, et al .Establishment and clinical performance evaluationof 2019 novel coronavirus antibody colloidal golddetection method[J]. Chinese Journal of InfectiousDiseases, 2020, 38(3): 139-144.
[5] 高原,陈川,王晶.2019 新型冠状病毒的抗原抗体检测[J]. 计量学报, 2020, 41(5):513-517. GAO Yuang, CHEN Chuan, WANG Jing. Antigenand antibody detection of SARS-CoV-2[J]. ActaMetrologica Sinica, 2020,41(5): 513-517.
[6] 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. Preliminarystudy of serum 2019-nCoV IgM and IgG antibodiesin the diagnosis of COVID-19 [J]. Chin J Lab Med,2020,43(4): 352-357.
[7] QING Enya,HANTAK M,PERLMAN S,et al. Distinctroles for sialoside and protein receptors in coronavirusinfection [J]. mBio,2020, 11(1):e02764-19.
[8] AHMED S F, QUADEER A A, MCKAY M R.Preliminary identification of potential vaccine targetsfor the COVID-19 coronavirus (SARS-CoV-2) basedon SARS-CoV immunological studies[J]. Viruses,2020, 12(3): E254.
[9] 貌盼勇,朱雷,王佑春,等.SARS-CoV 特异性抗体产生规律的初步研究[J]. 中华流行病学杂志,2004, 25(10): 856-858. MAO Panyong, ZHU Lei, WANG Yuochun, et al.Study on the response of specific antibodies againstSARS-CoV in patients infected with SARS[J]. ChineseJournal of Epidemiology, 2004, 25(10): 856-858.
[10] 邹明园,吴国球.抗原交叉反应对新型冠状病毒血清特异性抗体检测的影响[J]. 临床检验杂志, 2020,38(3): 161-163. ZOU Mingyuan, WU Guoqiu. Effect of novelcoronavirus cross-reaction on serum specifi antibodydetection [J]. Chinese Journal of Clinical LaboratoryScience, 2020, 38(3): 161-163.
[11] 莫茜,秦炜,傅启华,等. 正确认识新型冠状病毒核酸检测的影响因素[J]. 中华检验医学杂志, 2020,43(3): 213-216. MO Qian, QIN Wei, FU Qihua, et al. Understandingthe influence factors in viral nucleic acid test of 2019novel coronavirus[J]. Chinese Journal of LaboratoryMedicine ,2020,43(3):213-216.
[12] 张瑞,李金明,张媛.如何减少新型冠状病毒核酸检测的假阴性[J].中华医学杂志, 2020, 100(11):801-804. ZHANG Rui, LI Jinming. The way to reduce the falsenegative results of 2019 novel coronavirus nucleic aciddetection [J]. National Medical Journal of China,2020, 100(11): 801-804.
[13] 郑培明,崔发财,张福明,等.新型冠状病毒IgM和IgG 抗体不同检测方法在新型冠状病毒感染中的临床应用评价[J]. 检验医学, 2020, 35(4): 291-294. ZHENG Peiming,CUI Facai,ZHANG Fuming,etal. Clinical evaluation of different detection methods ofSARS-CoV-2 IgM and IgG antibodies in the COVID-19diagnosis [J]. Laboratory Medicine,2020,35 (4):291-294.

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备注/Memo

备注/Memo:
收稿日期:2020-06-12修回日期:2020-06-30基金项目:国家自然科学基金面上项目(81872076);深圳市医疗卫生三名工程项目(SZSM201601062) 。作者简介:胡纪文(1967-)男,学士,主任技师,研究方向:临床免疫、免疫学检验方法与质量控制,E-mail:shenzhenaw@163.com。通讯作者:张秀明(1964-)男,硕士,主任技师,研究方向:临床生化、临床实验室标准化,E-mail: zxm0760@163.com。
更新日期/Last Update: 2020-10-08