2019年新型冠状病毒抗体胶体金检测方法的建立及临床性能评估/ 中华传染病杂志

中华传染病杂志 Pub Date : 2020-03-03 DOI:10.3760/CMA.J.CN311365-20200221-00101

Hui Li, Yongyin Li, Zhigao Zhang, Zhen Lu, Yi Wang, Guanfeng Lin, Taixue An, Xiumei Hu, Q. Lai, Xuan Yi, Zhihong Liu, Xiangming Zhai, Jian Sun, Yabing Guo, Jiatao Lu, Xiaoyong Zhang, Yingsong Wu, Jinlin Hou

{"title":"2019年新型冠状病毒抗体胶体金检测方法的建立及临床性能评估/ 中华传染病杂志","authors":"Hui Li, Yongyin Li, Zhigao Zhang, Zhen Lu, Yi Wang, Guanfeng Lin, Taixue An, Xiumei Hu, Q. Lai, Xuan Yi, Zhihong Liu, Xiangming Zhai, Jian Sun, Yabing Guo, Jiatao Lu, Xiaoyong Zhang, Yingsong Wu, Jinlin Hou","doi":"10.3760/CMA.J.CN311365-20200221-00101","DOIUrl":null,"url":null,"abstract":"Objective \nTo establish a colloidal gold technique assay for the rapid detection of immunoglobulin(Ig) M and IgG antibodies against 2019 novel coronavirus (2019-nCoV) and to evaluate its clinical performance. \n \n \nMethods \nA total of 278 patients who were treated at Wuhan Hankou Hospital and the People's Hospital of Honghu from February 12, 2020 to February 20, 2020 were collected. According to the diagnostic criteria, 89 patients were confirmed with 2019-nCoV nucleic acid positive diagnosis, and 189 were 2019-nCoV nucleic acid-negative suspected patients. A total of 273 medical examiners from Nanfang Hospital, Southern Medical University from 2015 to 2018 were selected as controls. The serum samples of patients were collected. 2019-nCoV nucleic proteins were obtained from prokaryotic expression vectors. Indirect IgM and IgG colloidal gold techniques were established by using recombinant N protein. 2019-nCoV nucleic acid detection by reverse transcription-polymerase chain reaction (RT-PCR) was used as control. Serum specimens were tested for 2019-nCoV IgM and IgG. The specificity and sensitivity of colloidal gold assay were analyzed. \n \n \nResults \nThe sensitivity and specificity of IgM detection reagents were 78.7% and 98.2%, respectively, those of IgG detection reagents were 73.0% and 99.3%, respectively, and those of IgM combined with IgG detection were 87.6% and 98.2%, respectively. For suspected patients with negative 2019-nCoV nucleic acid, the positive rates of IgM and IgG were 59.8% (113/189) and 52.9% (100/189), respectively, and the positive rate of IgM combined with IgG detection was 66.1% (125/189). \n \n \nConclusion \nThis reagent of 2019-nCoV antibodies detection (colloidal gold technique) fulfills the requirement for clinical application with high specificity and sensitivity, which can be served as a supplementary detection method for 2019-nCoV nucleic acid detection by RT-PCR. \n \n \nKey words: \nCoronavirus infection; Novel coronavirus; Gold colloid; Antibodies; Clinical performance","PeriodicalId":10127,"journal":{"name":"中华传染病杂志","volume":"24 2‐3","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2020-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"3","resultStr":"{\"title\":\"Establishment and clinical performance evaluation of 2019 novel coronavirus antibody colloidal gold detection method/ 中华传染病杂志\",\"authors\":\"Hui Li, Yongyin Li, Zhigao Zhang, Zhen Lu, Yi Wang, Guanfeng Lin, Taixue An, Xiumei Hu, Q. Lai, Xuan Yi, Zhihong Liu, Xiangming Zhai, Jian Sun, Yabing Guo, Jiatao Lu, Xiaoyong Zhang, Yingsong Wu, Jinlin Hou\",\"doi\":\"10.3760/CMA.J.CN311365-20200221-00101\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Objective \\nTo establish a colloidal gold technique assay for the rapid detection of immunoglobulin(Ig) M and IgG antibodies against 2019 novel coronavirus (2019-nCoV) and to evaluate its clinical performance. \\n \\n \\nMethods \\nA total of 278 patients who were treated at Wuhan Hankou Hospital and the People's Hospital of Honghu from February 12, 2020 to February 20, 2020 were collected. According to the diagnostic criteria, 89 patients were confirmed with 2019-nCoV nucleic acid positive diagnosis, and 189 were 2019-nCoV nucleic acid-negative suspected patients. A total of 273 medical examiners from Nanfang Hospital, Southern Medical University from 2015 to 2018 were selected as controls. The serum samples of patients were collected. 2019-nCoV nucleic proteins were obtained from prokaryotic expression vectors. Indirect IgM and IgG colloidal gold techniques were established by using recombinant N protein. 2019-nCoV nucleic acid detection by reverse transcription-polymerase chain reaction (RT-PCR) was used as control. Serum specimens were tested for 2019-nCoV IgM and IgG. The specificity and sensitivity of colloidal gold assay were analyzed. \\n \\n \\nResults \\nThe sensitivity and specificity of IgM detection reagents were 78.7% and 98.2%, respectively, those of IgG detection reagents were 73.0% and 99.3%, respectively, and those of IgM combined with IgG detection were 87.6% and 98.2%, respectively. For suspected patients with negative 2019-nCoV nucleic acid, the positive rates of IgM and IgG were 59.8% (113/189) and 52.9% (100/189), respectively, and the positive rate of IgM combined with IgG detection was 66.1% (125/189). \\n \\n \\nConclusion \\nThis reagent of 2019-nCoV antibodies detection (colloidal gold technique) fulfills the requirement for clinical application with high specificity and sensitivity, which can be served as a supplementary detection method for 2019-nCoV nucleic acid detection by RT-PCR. \\n \\n \\nKey words: \\nCoronavirus infection; Novel coronavirus; Gold colloid; Antibodies; Clinical performance\",\"PeriodicalId\":10127,\"journal\":{\"name\":\"中华传染病杂志\",\"volume\":\"24 2‐3\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2020-03-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"3\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"中华传染病杂志\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.3760/CMA.J.CN311365-20200221-00101\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"中华传染病杂志","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3760/CMA.J.CN311365-20200221-00101","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}

引用次数: 3

摘要

目的建立一种胶体金技术快速检测2019年新型冠状病毒（2019-nCoV）免疫球蛋白（Ig）M和IgG抗体的方法，并评估其临床性能。方法收集2020年2月12日至2020年2月20日在武汉市汉口医院和洪湖市人民医院就诊的患者共278例。根据诊断标准，89例患者确诊为2019-nCoV核酸阳性，189例为2019-nCoV核酸阴性疑似患者。选取南方医科大学南方医院2015年至2018年共273名体检人员作为对照。采集患者血清样本。从原核表达载体中获得2019-nCoV核蛋白。利用重组N蛋白建立了间接IgM和IgG胶体金技术。2019-nCoV核酸检测采用反转录聚合酶链反应（RT-PCR）作为对照。对血清标本进行了 2019-nCoV IgM 和 IgG 检测。分析了胶体金检测法的特异性和灵敏度。结果 IgM检测试剂的灵敏度和特异性分别为78.7%和98.2%，IgG检测试剂的灵敏度和特异性分别为73.0%和99.3%，IgM与IgG联合检测的灵敏度和特异性分别为87.6%和98.2%。对于2019-nCoV核酸阴性的疑似患者，IgM和IgG的阳性率分别为59.8%（113/189）和52.9%（100/189），IgM联合IgG检测的阳性率为66.1%（125/189）。结论该2019-nCoV抗体检测试剂（胶体金技术）符合临床应用要求，特异性强，灵敏度高，可作为RT-PCR检测2019-nCoV核酸的辅助检测方法。关键词冠状病毒感染新型冠状病毒胶体金抗体临床表现

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Establishment and clinical performance evaluation of 2019 novel coronavirus antibody colloidal gold detection method/ 中华传染病杂志

Objective To establish a colloidal gold technique assay for the rapid detection of immunoglobulin(Ig) M and IgG antibodies against 2019 novel coronavirus (2019-nCoV) and to evaluate its clinical performance. Methods A total of 278 patients who were treated at Wuhan Hankou Hospital and the People's Hospital of Honghu from February 12, 2020 to February 20, 2020 were collected. According to the diagnostic criteria, 89 patients were confirmed with 2019-nCoV nucleic acid positive diagnosis, and 189 were 2019-nCoV nucleic acid-negative suspected patients. A total of 273 medical examiners from Nanfang Hospital, Southern Medical University from 2015 to 2018 were selected as controls. The serum samples of patients were collected. 2019-nCoV nucleic proteins were obtained from prokaryotic expression vectors. Indirect IgM and IgG colloidal gold techniques were established by using recombinant N protein. 2019-nCoV nucleic acid detection by reverse transcription-polymerase chain reaction (RT-PCR) was used as control. Serum specimens were tested for 2019-nCoV IgM and IgG. The specificity and sensitivity of colloidal gold assay were analyzed. Results The sensitivity and specificity of IgM detection reagents were 78.7% and 98.2%, respectively, those of IgG detection reagents were 73.0% and 99.3%, respectively, and those of IgM combined with IgG detection were 87.6% and 98.2%, respectively. For suspected patients with negative 2019-nCoV nucleic acid, the positive rates of IgM and IgG were 59.8% (113/189) and 52.9% (100/189), respectively, and the positive rate of IgM combined with IgG detection was 66.1% (125/189). Conclusion This reagent of 2019-nCoV antibodies detection (colloidal gold technique) fulfills the requirement for clinical application with high specificity and sensitivity, which can be served as a supplementary detection method for 2019-nCoV nucleic acid detection by RT-PCR. Key words: Coronavirus infection; Novel coronavirus; Gold colloid; Antibodies; Clinical performance

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

中华传染病杂志

自引率

0.00%

发文量

5280

期刊介绍： The Chinese Journal of Infectious Diseases was founded in February 1983. It is an academic journal on infectious diseases supervised by the China Association for Science and Technology, sponsored by the Chinese Medical Association, and hosted by the Shanghai Medical Association. The journal targets infectious disease physicians as its main readers, taking into account physicians of other interdisciplinary disciplines, and timely reports on leading scientific research results and clinical diagnosis and treatment experience in the field of infectious diseases, as well as basic theoretical research that has a guiding role in the clinical practice of infectious diseases and is closely integrated with the actual clinical practice of infectious diseases. Columns include reviews (including editor-in-chief reviews), expert lectures, consensus and guidelines (including interpretations), monographs, short monographs, academic debates, epidemic news, international dynamics, case reports, reviews, lectures, meeting minutes, etc.