[1]王 丹,于海立,张露方,等.国产新型冠状病毒抗体胶体金法检测试剂盒在低流行区应用的诊断效果评价[J].现代检验医学杂志,2021,36(03):103-107.[doi:10.3969/j.issn.1671-7414.2021.03.024]
 WANG Dan,YU Hai-li,ZHANG Lu-fang,et al.Evaluation of Two Different Domestic Colloidal Gold Assay Kit forNew Coronavirus Antibody in Low Endemic Areas[J].Journal of Modern Laboratory Medicine,2021,36(03):103-107.[doi:10.3969/j.issn.1671-7414.2021.03.024]
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国产新型冠状病毒抗体胶体金法检测试剂盒在低流行区应用的诊断效果评价()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第36卷
期数:
2021年03期
页码:
103-107
栏目:
新型冠状病毒肺炎检验专题
出版日期:
2021-05-31

文章信息/Info

Title:
Evaluation of Two Different Domestic Colloidal Gold Assay Kit forNew Coronavirus Antibody in Low Endemic Areas
文章编号:
1671-7414(2021)03-103-05
作者:
王 丹于海立张露方
(航空总医院检验科,北京 100012)
Author(s):
WANG Dan YU Hai-li ZHANG Lu-fang QIN Ying HE Chun-yan QU fen
(Department of Clinical Laboratory,Aviation General Hospital,Beijing 100012,China)
关键词:
新型冠状病毒IgM 抗体IgG 抗体胶体金法效果评价
分类号:
R373.19;R446
DOI:
10.3969/j.issn.1671-7414.2021.03.024
文献标志码:
A
摘要:
目的 探讨评价两种不同的国产新型冠状病毒抗体胶体金法检测试剂盒的 2019-nCoV 免疫球蛋白 M 抗体(抗 -IgM)和免疫球蛋白 G 抗体(抗 -IgG)检测试剂在低流行区北京地区的应用与诊断效果,指导临床合理应用。方法 选取新型冠状病毒肺炎(COVID-19)确诊患者 29 例和非感染筛查人群 19 411 例的血清,采用胶体金免疫层析法,评价国产珠海丽珠及唐山英诺特的 2019-nCoV 抗体检测试剂盒的的灵敏度、特异度、假阳性率等性能指标。结果 英诺特 2019-nCoV 灵敏度稍高于丽珠 2019-nCoV,灵敏度分别为 58.62%,55.17%;抗体全阴组的标本采集时间明显小于抗体阳性各组(P < 0.05);低流行区两种试剂复合报告抗体假阳性率 0.16%,2019-nCoV IgG 假阳性率英诺特高于丽珠;同一品牌的 2019-nCoV IgM 假阳性率显著高于 IgG(英诺特 χ2=14.756 09,P=0.000 0;丽珠 χ2=27.492 62,P=0.000 0)。结论 2019-nCoV 抗体检测快速、简单易操作、特异度高,可作为新冠的快速筛查指标;两种试剂盒的特异度、正确率和阴性预测值较好,出现阳性结果时应用另一种试剂盒进行复测,可减少通报临床的假阳性率;新冠抗体阳性报告的应用与分析应结合流行区及临床综合判断。

参考文献/References:

[1] World Health Organization.(2020). Clinicalmanagement of severe acute respiratory infectionwhen novel coronavirus (nCoV) infection is suspected:interim guidance[OL]. https://www.who.int/iris/handle/10665/330854.
[2] ZHONG N S , ZHENG B J , LI Y M , et al. Epidemiology and cause of severe acute respiratory syndrome(SARS) in Guangdong, People’s Republic of China, inFebruary, 2003[J]. Lancet,2003, 362(9393):1353-1358.
[3] WONG Gary, LIU Wenjun, LIU Yingxia, et al. MERS,SARS, and Ebola: the role of super-spreaders in infectious disease[J]. Cell Host Microbe 2015,18(4):398-401.
[4] ZHU Na , ZHANG Dingyu , WANG Wenling , et al.A Novel Coronavirus from Patients with Pneumoniain China, 2019[J]. New England Journal of Medicine,2020, 382(8):727-733.
[5] LIU Rui,HAN Huan,LIU Fang,et al. Positiverate of RT-PCR detection of SARS-CoV-2 infection in4 880 cases from one hospital in Wuhan, China, fromJan to Feb 2020[J]. Clin Chim Acta, 2020,505:172-175.
[6] WANG Wenling, XU Yanli, GAO Ruqin, et al. Detection of SARS-CoV-2 in different types of clinical specimens[J]. the Journal of the American Medical, 2020,323(18):1843-1844.
[7] 中华人民共和国国家卫生健康委员会(国卫办医函 184):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.184:Notification on the issuance ofCOVID-19 medical programctrial seventh edition[EB/OL] (2020-03-04). http:/www.nhc.gov.cn/xcs/zhengcwj/202003/46c9294a7dfe4cef80dc7f5912eb1989.shtml.
[8] NIE Jianhui, LI Qianqian, WU Jiajing, et al. Establishment and validation of a pseudovirus neutralizationassay for SARS-CoV-2[J]. Emerging Microbes and Infections, 2020, 9(1):680-686.
[9] LI Qun, GUAN Xuhua, WU Peng, et al. Earlytransmission dynamics in Wuhan, China, of NovelCoronavirus-infected pneumonia[J]. The New EnglandJournal of Medicine, 2020,382(13):1199-1207.
[10] 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]. Journal of Medical Virology, 2020,92(9):1518-1524.
[11] TO K W , TSANG T Y , LEUNG W S, et al. Temporalprofiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infectionby SARS-CoV-2: an observational cohort study[J]. TheLancet Infectious Diseases, 2020, 20(5):565-574.
[12] XU D , ZHANG Z , JIN L , et al. Persistent shedding ofviable SARS-CoV in urine and stool of SARS patientsduring the convalescent phase[J]. European Journal ofClinical Microbiology and Infectious Diseases, 2005,24(3):165-171.
[13] 张稳健 , 吕欣 , 黄驰 , 等 . 胶体金免疫层析法检测新型冠状病毒 IgM/IgG 抗体的临床评价与应用 [J]. 病毒学报 ,2020,36(3):348-354. ZHANG Wenjian, L? Xin, HUANG Chi, et al. Clinicalevaluation and application of detection of IgM and IgGantibodies against-SARS-CoV-2 using a colloidal goldimmunochromatography assay[J]. Chinese Journal ofVirology,2020,36(3):348-354.
[14] 童伟 , 陈登奕 , 陈俊文 , 等 .2019-nCoV 总抗体两种免疫学检测方法的应用评价 [J]. 现代检验医学杂志 ,2020,35(2):80-82. TONG Wei, CHEN Dengyi, CHEN Junwen, et al.Application evaluation of two immunological detectionmethods of 2019-NCoV specific antibodies[J]. Journal of Modern Laboratory Medicine,2020,35(2):80-82.
[15] GUO Li,REN Lili,YANG Siyuan,et al. Profilingearly humoral response to diagnose novel coronavirusdisease (COVID-19)[J].Clinical Infectious Diseases,2020,71(15):778-785.
[16] YAN Ying, CHANG Le, WANG Lunan. Laboratorytesting of SARS‐CoV, MERS‐CoV, and SARS‐CoV‐2 (2019‐nCoV): Current status, challenges,and countermeasures[J]. Reviews in Medical Virology,2020, 30(3):e2106.
[17] 李雪寒 , 赵 瑾 , 潘运宝 , 等 . 新型冠状病毒特异性抗体检测现状及应用思考 [J]. 中华检验医学杂志 ,2020,43(7):691-696. LI Xuehan, ZHAO Jin, PAN Yunbao, et al. Statusquoand review of clinical application of antibody detectionfor 2019-nCoV[J]. Chinese Journal of LaboratoryMedicine,2020,43(7):691-696.
[18] HANSON K E , CALIENDO A M , ARIAS C A , etal. Infectious diseases society of america guidelineson the diagnosis of COVID-19:serologic testing[J].Clinical Infectious Diseases. http://doi.org/10.1093/cid/ciab048.2020.
[19] POST N,EDDY D,HUNTLEY, C,et al. Antibodyresponse to SARS-CoV-2 infection in humans:A systematic review[J]. PLoS One. 2020,15(12):e0244126.
[20] BOND K,NICHOLSON S,LIM S M,et al. Evaluation of serological tests for SARS-CoV-2: Implicationsfor serology testing in a low-prevalence setting[J].TheJournal of Infectious Diseases. 2020,222(8):1280-1288.
[21] World Health Orgnaization. Laboratory testing for 2019novel coronavirus (2019-nCoV) in suspected humancases interim guidance[S].Geneva: World HealthOrganization, 2020.
[22] NG K W,FAULKNER N,CORNISH G H,et al. Preexisting and de novo humoral immunity to SARSCoV-2 in humans[J].Science.2020,370(6522): 1339-1343.
[23] WANG Yunshan,SHEN Hong,SUN Shanhui,et al. Analysis of false positive associated with antibody tests for SARS-CoV in SLE patients[J].ActaBiologiae Experimentalis Sinica.2003,36(4):314-317.
[24] SHAO Xiuping, GUO Xiaojie, ESPER F, et al.Seroepidemiology of group I human coronaviruses inchildren[J]. Journal of Clinical Virology, 2007, 40 (3):207-213.
[25] CHAN K H , CHAN J F W , TSE H , et al. Cross-reactive antibodies in convalescent SARS patients’ seraagainst the emerging novel human coronavirus EMC(2012) by both immunofluorescent and neutralizingantibody tests[J]. Journal of Infection, 2013, 67(2):130-140.
[26] DIJKMAN R , JEBBINK M F , GAUNT E , et al. Thedominance of human coronavirus OC43 and NL63infections in infants[J]. Journal of Clinical Virology,2012, 53(2):135-139.
[27] SUN Z F , MENG X J . Antigenic cross-reactivitybetween the nucleocapsid protein of severe acuterespiratory syndrome (SARS) coronavirus andpolyclonal antisera of antigenic group I animalcoronaviruses: implication for SARS diagnosis[J].Journal of Clinical Microbiology, 2004, 42(5):2351-2352.
[28] WOO P C,LAU S K,WONG B H,et al. False-positive results in a recombinant severe acute respiratorysyndrome-associated coronavirus ( SARS-CoV) nucleocapsid enzymelinked immunosorbent assay dueto HCoV-OC43 and HCoV-229E rectified by westernblotting with recombinant SARS-CoV spike polypeptide[J].Journal of Clinical Microbiology,2004,42( 12) :5885-5888.
[29] 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. The effect of antigeniccross reaction on the detection of serum specificantibody of novel coronavirus [J]. Chinese Journal ofClinical Laboratory Science, 2020,38(3):161-163.
[30] 王远芳 , 邓杰伦 , 敖科萍 , 等 . 三种 SARS-CoV-2 抗体胶体金试剂诊断效能评价及假阳性控制策略探讨[J]. 中国呼吸与危重监护杂志 , 2020,19(3):214-218. WANG Yuanfang, DENG Jielun, AO Keping, et al.Evaluation of three colloidal gold reagents for SARSCoV-2-antibody and the control strategy of falsepositive[J]. Chinese Journal of Respiratory and CriticalCare Medicine, 2020, 19(3):214-218.
[31] ZHAO Juanjuan,YUAN Quan,WANG Haiyan, et al.Antibody responses to SARS-CoV-2 in patients withnovel coronavirus disease 2019[J]. Clinical InfectiousDiseases.2020,71(16):2027-2034.
[32] 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(3):99-102,109. ZHANG Yuan, ZHOU Zeqi, WANG Zhixian, et al.Discussion on the clinical value of combined detectionof SARS-CoV-2 nucleic acid,antigen and antibody[J].Journal of Modern Laboratory Medicine, 2020,35(5):99-102,109.

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备注/Memo

备注/Memo:
作者简介:王丹(1981-),女,硕士,副主任技师,研究方向:临床检验实验室质量指标,E-mail:wd9618@126.com。
通讯作者:曲芬,女,硕士,主任医师,研究方向:临床微生物检测技术及耐药机制研究,E-mail:qf302@163.com。
更新日期/Last Update: 1900-01-01