摘要
新型冠状病毒(SARS-CoV-2)感染暴发流行已成为全球公共卫生事件,急需快速有效的现场诊断试剂。为探讨SARS-CoV-2病毒IgM/IgG抗体胶体金免疫层析法检测效果及临床应用价值,本研究选取304例新冠肺炎临床诊断病例、114例SARS-CoV-2核酸检测阴性的正常人(138)及其他发热伴呼吸道症状病例(64),采用胶体金法对采自上述病例的血浆或血清标本进行IgM和IgG抗体检测,并选取部分病例进行了全血和血浆或血清标本的检测同源性比较,进一步对304例临床诊断病例的病毒核酸、IgM/IgG抗体的时间分布进行了分析。结果显示,304临床诊断病例中,SARS-CoV-2核酸检测阳性病例为105例,胶体金法检测SARS-CoV-2 IgM和IgG抗体的敏感性分别为76.2%(80/105)和86.6%(91/105),IgM/IgG抗体阳性总体符合率为96.1%(101/105);核酸、抗体均为阴性者为73例;其余126例临床诊断病例中,IgM阳性率为69.2%(87/126),IgG阳性率为98.3%(125/126),IgM/IgG总体符合率为100%(126/126)。健康人和其他发热病人中,IgM和IgG检测特异性分别为99%(200/202)和98%(198/202)。同源全血与血浆或血清标本抗体检测结果的总符合率为99%,显示两者具有高度一致性。本研究提示,胶体金法检测SARS-CoV-2抗体有较好的敏感性及特异性,可用于临床辅助诊断和流行病学调查等,具有较广泛的应用场景,在新冠肺炎疫情防控中具有一定的应用价值。
The pandemic of the novel coronavirus(SARS-CoV-2)infection has seriously threated global public health,a rapid and easily operated method for coronavirus disease 2019(COVID-19)diagnosis is needed. To evaluate the clinical application efficacy of the colloidal gold rapid test kit for detection of the IgM/IgG antibodies to SARS-CoV-2,a total of 304 clinical diagnosed cases,138 healthy donors of which 114 showed SARS-CoV-2 viral RNA negative and 64 other patients with fever and respiratory symptoms were selected for the study. The plasma or serum samples were tested for both IgM and IgG with the kit. Comparison of the detection coincidence with samples from whole blood and plasma or serum were also performed. Furthermore,the time distribution of SARS-CoV-2 viral RNA and IgM/IgG antibodies detections were analyzed. Results showed that,of the 304 clinical diagnosed cases,105 cases were positive for viral RNA detection,among which the detection sensitivity of IgM and IgG antibodies against SARS-CoV-2 by colloidal gold rapid assay was 76.2%(80/105)and 86.6%(91/105),respectively,and the overall coincidence rate of IgM/IgG antibody was 96.1%(101/105). 73 cases were negative for both nucleic acid and antibody detection. Of the remaining 126 clinical diagnosed cases,the positive rate of IgM and IgG was 69.2%(87/126)and 98.3%(125/126),respectively,and the overall coincidence rate of IgM/IgG antibody was 100%(126/126). In detections in healthy and other fever patients,the specificity of IgM and IgG was 99%(200/202)and 98%(198/202),respectively,and the total coincidence rate of antibody detection results of homologous whole blood and plasma samples was 99%,indicating a high consistency. In this study,the detection assay of SARS-CoV-2 antibodies using colloidal gold method showed satisfactory detection effect. It could be used in tandem with the clinical diagnosis and for epidemiological investigation,which could be applied in a wide range of scenarios and play a valuable role in prevention and control of SARS-CoV-2 pandemic.
作者
张稳健
吕欣
黄驰
卫明
李顺清
彭华丽
彭问文
吴勇进
马杰
盖中涛
杨楷
ZHANG Wenjian;LYU Xin;HUANG Chi;WEI Ming;LI Shunqing;PENG Huali;PENG Wenwen;WU Yongjin;MA Jie;GAI Zhongtao;YANG Kai(Hubei Provincial Hospital of Integrated Chinese&Western Medicine,Wuhan 430015,China;Qilu Children's Hospital of Shandong University,Jinan 250022,China)
出处
《病毒学报》
CAS
CSCD
北大核心
2020年第3期348-354,共7页
Chinese Journal of Virology
基金
科技部项目“新型冠状病毒(2019‐nCoV)快速检测产品研发”。
