基于微阵列化学发光技术的新型冠状病毒(SARS-CoV-2)抗体检测试剂盒研制及应用  

Development and Application of SARS-CoV-2 Antibody Detection Kit Based on Microarray Chemiluminescence Technology

作　　者：陈琳 盛祝毅 方煜 汪玲 曾诚 Chen Lin;Sheng Zhuyi;Fang Yu;Wang Ling;Zeng Cheng(Yangzhou Customs,Yangzhou Jiangsu 225009;Northern Jiangsu People's Hospital in Yangzhou,Yangzhou Jiangsu 225009)

机构地区：[1]扬州海关,江苏扬州225009 [2]扬州苏北人民医院,江苏扬州225009

出　　处：《口岸卫生控制》2023年第1期36-42,共7页Port Health Control

基　　金：海关总署科研项目(2021HK132);南京海关科研项目(2021KJ26)。

摘　　要：目的建立新型冠状病毒(SARS-CoV-2)抗体检测方法。方法考核基于微阵列化学发光技术的新型冠状病毒(SARS-CoV-2)抗体检测试剂盒的检测性能,并对临床疑似病例血清样本进行采集,在实验室完成检测、确认。结果对本试剂盒进行性能分析显示其具有高灵敏性、高特异性和良好的重复性。通过对563例疑似样本的检测,发现抗体检出量的变化对被检测对象的感染状态具有一定的指示作用。结论作为对新冠病毒核酸检测的有力补充,基于微阵列化学发光技术的新型冠状病毒(SARS-CoV-2)抗体检测试剂盒能够同时定性检测血清样本中的新型冠状病毒(SARS-CoV-2)IgM和总抗体,可为入境人员检疫监测提供更全面的信息,有望对优化入境管理措施、减轻入境管理的工作负荷提供参考依据。Objective To establish a method for detecting antibodies to novel coronavirus(SARS-CoV-2).Methods The detection performance of the novel coronavirus(SARS-CoV-2)antibody detection kit based on microarray chemiluminescence technology was evaluated,and serum samples of clinical suspected cases were collected,and the detection and confirmation were completed in the laboratory.Results The performance analysis of the kit showed that it had high sensitivity,high specificity and good repeatability.Through the detection of 563 suspected samples,it was found that the change in the amount of anti-virus detection had a certain indication effect on the infection status of the tested object.Conclusion As a powerful complement to the detection of COVID-19 nucleic acid,the novel coronavirus(SARS-CoV-2)antibody detection kit based on microarray chemiluminescence technology can simultaneously and quantitatively detect the IgM and total antibody of novel coronavirus(SARS-CoV-2)in serum samples.It can provide more comprehensive information for quarantine monitoring of entry personnel,and is expected to provide reference basis for optimizing entry management measures and reducing the workload of entry management.

关 键 词：微阵列化学发光 SARS-CoV-2 抗体检测 入境管理 

分 类 号：R185[医药卫生—流行病学]