Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis.
Identifieur interne : 000576 ( PubMed/Checkpoint ); précédent : 000575; suivant : 000577Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis.
Auteurs : Zhengtu Li [République populaire de Chine] ; Yongxiang Yi [République populaire de Chine] ; Xiaomei Luo [République populaire de Chine] ; Nian Xiong [République populaire de Chine] ; Yang Liu [République populaire de Chine] ; Shaoqiang Li [République populaire de Chine] ; Ruilin Sun [République populaire de Chine] ; Yanqun Wang [République populaire de Chine] ; Bicheng Hu [République populaire de Chine] ; Wei Chen [République populaire de Chine] ; Yongchen Zhang [République populaire de Chine] ; Jing Wang [République populaire de Chine] ; Baofu Huang [République populaire de Chine] ; Ye Lin [République populaire de Chine] ; Jiasheng Yang [République populaire de Chine] ; Wensheng Cai [République populaire de Chine] ; Xuefeng Wang [République populaire de Chine] ; Jing Cheng [République populaire de Chine] ; Zhiqiang Chen [République populaire de Chine] ; Kangjun Sun [République populaire de Chine] ; Weimin Pan [République populaire de Chine] ; Zhifei Zhan [République populaire de Chine] ; Liyan Chen [République populaire de Chine] ; Feng Ye [République populaire de Chine]Source :
- Journal of medical virology [ 1096-9071 ] ; 2020.
Abstract
The outbreak of the novel coronavirus disease (COVID-19) quickly spread all over China and to more than 20 other countries. Although the virus (severe acute respiratory syndrome coronavirus [SARS-Cov-2]) nucleic acid real-time polymerase chain reaction (PCR) test has become the standard method for diagnosis of SARS-CoV-2 infection, these real-time PCR test kits have many limitations. In addition, high false-negative rates were reported. There is an urgent need for an accurate and rapid test method to quickly identify a large number of infected patients and asymptomatic carriers to prevent virus transmission and assure timely treatment of patients. We have developed a rapid and simple point-of-care lateral flow immunoassay that can detect immunoglobulin M (IgM) and IgG antibodies simultaneously against SARS-CoV-2 virus in human blood within 15 minutes which can detect patients at different infection stages. With this test kit, we carried out clinical studies to validate its clinical efficacy uses. The clinical detection sensitivity and specificity of this test were measured using blood samples collected from 397 PCR confirmed COVID-19 patients and 128 negative patients at eight different clinical sites. The overall testing sensitivity was 88.66% and specificity was 90.63%. In addition, we evaluated clinical diagnosis results obtained from different types of venous and fingerstick blood samples. The results indicated great detection consistency among samples from fingerstick blood, serum and plasma of venous blood. The IgM-IgG combined assay has better utility and sensitivity compared with a single IgM or IgG test. It can be used for the rapid screening of SARS-CoV-2 carriers, symptomatic or asymptomatic, in hospitals, clinics, and test laboratories.
DOI: 10.1002/jmv.25727
PubMed: 32104917
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Chine</country><wicri:regionArea>The 1st Affiliated Hospital of Nanchang University, Nanchang</wicri:regionArea><placeName><settlement type="city">Nanchang</settlement><region type="province">Jiangxi</region></placeName></affiliation></author><author><name sortKey="Li, Shaoqiang" sort="Li, Shaoqiang" uniqKey="Li S" first="Shaoqiang" last="Li">Shaoqiang Li</name><affiliation wicri:level="3"><nlm:affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou</wicri:regionArea><placeName><settlement 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Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou</wicri:regionArea><placeName><settlement type="city">Jiangmen</settlement><region type="province">Guangdong</region></placeName></affiliation></author><author><name sortKey="Hu, Bicheng" sort="Hu, Bicheng" uniqKey="Hu B" first="Bicheng" last="Hu">Bicheng Hu</name><affiliation wicri:level="3"><nlm:affiliation>Wuhan No. 1 Hospital, Wuhan, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Wuhan No. 1 Hospital, Wuhan</wicri:regionArea><placeName><settlement type="city">Wuhan</settlement><region 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Nanjing</wicri:regionArea><wicri:noRegion>Nanjing</wicri:noRegion></affiliation></author><author><name sortKey="Lin, Ye" sort="Lin, Ye" uniqKey="Lin Y" first="Ye" last="Lin">Ye Lin</name><affiliation wicri:level="3"><nlm:affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou</wicri:regionArea><placeName><settlement type="city">Jiangmen</settlement><region type="province">Guangdong</region></placeName></affiliation></author><author><name sortKey="Yang, Jiasheng" sort="Yang, Jiasheng" uniqKey="Yang J" first="Jiasheng" last="Yang">Jiasheng Yang</name><affiliation wicri:level="1"><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou, Guangdong, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou, Guangdong</wicri:regionArea><wicri:noRegion>Guangdong</wicri:noRegion></affiliation></author><author><name sortKey="Cai, Wensheng" sort="Cai, Wensheng" uniqKey="Cai W" first="Wensheng" last="Cai">Wensheng Cai</name><affiliation wicri:level="1"><nlm:affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing</wicri:regionArea><wicri:noRegion>Nanjing</wicri:noRegion></affiliation></author><author><name sortKey="Wang, Xuefeng" sort="Wang, Xuefeng" uniqKey="Wang X" first="Xuefeng" last="Wang">Xuefeng Wang</name><affiliation wicri:level="1"><nlm:affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing</wicri:regionArea><wicri:noRegion>Nanjing</wicri:noRegion></affiliation></author><author><name sortKey="Cheng, Jing" sort="Cheng, Jing" uniqKey="Cheng J" first="Jing" last="Cheng">Jing Cheng</name><affiliation wicri:level="3"><nlm:affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou</wicri:regionArea><placeName><settlement type="city">Jiangmen</settlement><region type="province">Guangdong</region></placeName></affiliation></author><author><name sortKey="Chen, Zhiqiang" sort="Chen, Zhiqiang" uniqKey="Chen Z" first="Zhiqiang" last="Chen">Zhiqiang Chen</name><affiliation wicri:level="1"><nlm:affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing</wicri:regionArea><wicri:noRegion>Nanjing</wicri:noRegion></affiliation></author><author><name sortKey="Sun, Kangjun" sort="Sun, Kangjun" uniqKey="Sun K" first="Kangjun" last="Sun">Kangjun Sun</name><affiliation wicri:level="1"><nlm:affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing</wicri:regionArea><wicri:noRegion>Nanjing</wicri:noRegion></affiliation></author><author><name sortKey="Pan, Weimin" sort="Pan, Weimin" uniqKey="Pan W" first="Weimin" last="Pan">Weimin Pan</name><affiliation wicri:level="1"><nlm:affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing</wicri:regionArea><wicri:noRegion>Nanjing</wicri:noRegion></affiliation></author><author><name sortKey="Zhan, Zhifei" sort="Zhan, Zhifei" uniqKey="Zhan Z" first="Zhifei" last="Zhan">Zhifei Zhan</name><affiliation wicri:level="1"><nlm:affiliation>Hunan Provincial Center for Disease Control and Prevention, Changsha, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Hunan Provincial Center for Disease Control and Prevention, Changsha</wicri:regionArea><wicri:noRegion>Changsha</wicri:noRegion></affiliation></author><author><name sortKey="Chen, Liyan" sort="Chen, Liyan" uniqKey="Chen L" first="Liyan" last="Chen">Liyan Chen</name><affiliation wicri:level="3"><nlm:affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou</wicri:regionArea><placeName><settlement type="city">Jiangmen</settlement><region type="province">Guangdong</region></placeName></affiliation></author><author><name sortKey="Ye, Feng" sort="Ye, Feng" uniqKey="Ye F" first="Feng" last="Ye">Feng Ye</name><affiliation wicri:level="3"><nlm:affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou</wicri:regionArea><placeName><settlement type="city">Jiangmen</settlement><region 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last="Li">Zhengtu Li</name><affiliation wicri:level="3"><nlm:affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou</wicri:regionArea><placeName><settlement type="city">Jiangmen</settlement><region type="province">Guangdong</region></placeName></affiliation></author><author><name sortKey="Yi, Yongxiang" sort="Yi, Yongxiang" uniqKey="Yi Y" first="Yongxiang" last="Yi">Yongxiang Yi</name><affiliation wicri:level="1"><nlm:affiliation>The 2nd Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>The 2nd Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing</wicri:regionArea><wicri:noRegion>Nanjing</wicri:noRegion></affiliation></author><author><name sortKey="Luo, Xiaomei" sort="Luo, Xiaomei" uniqKey="Luo X" first="Xiaomei" last="Luo">Xiaomei Luo</name><affiliation wicri:level="1"><nlm:affiliation>Chongqing Public Health Medical Center, Chongqing, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Chongqing Public Health Medical Center, Chongqing</wicri:regionArea><wicri:noRegion>Chongqing</wicri:noRegion></affiliation></author><author><name sortKey="Xiong, Nian" sort="Xiong, Nian" uniqKey="Xiong N" first="Nian" last="Xiong">Nian Xiong</name><affiliation wicri:level="3"><nlm:affiliation>Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan</wicri:regionArea><placeName><settlement type="city">Wuhan</settlement><region type="région">Hubei</region></placeName></affiliation></author><author><name sortKey="Liu, Yang" sort="Liu, Yang" uniqKey="Liu Y" first="Yang" last="Liu">Yang Liu</name><affiliation wicri:level="3"><nlm:affiliation>The 1st Affiliated Hospital of Nanchang University, Nanchang, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>The 1st Affiliated Hospital of Nanchang University, Nanchang</wicri:regionArea><placeName><settlement type="city">Nanchang</settlement><region type="province">Jiangxi</region></placeName></affiliation></author><author><name sortKey="Li, Shaoqiang" sort="Li, Shaoqiang" uniqKey="Li S" first="Shaoqiang" last="Li">Shaoqiang Li</name><affiliation wicri:level="3"><nlm:affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou</wicri:regionArea><placeName><settlement type="city">Jiangmen</settlement><region type="province">Guangdong</region></placeName></affiliation></author><author><name sortKey="Sun, Ruilin" sort="Sun, Ruilin" uniqKey="Sun R" first="Ruilin" last="Sun">Ruilin Sun</name><affiliation wicri:level="1"><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou, Guangdong, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou, Guangdong</wicri:regionArea><wicri:noRegion>Guangdong</wicri:noRegion></affiliation></author><author><name sortKey="Wang, Yanqun" sort="Wang, Yanqun" uniqKey="Wang Y" first="Yanqun" last="Wang">Yanqun Wang</name><affiliation wicri:level="3"><nlm:affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou</wicri:regionArea><placeName><settlement type="city">Jiangmen</settlement><region type="province">Guangdong</region></placeName></affiliation></author><author><name sortKey="Hu, Bicheng" sort="Hu, Bicheng" uniqKey="Hu B" first="Bicheng" last="Hu">Bicheng Hu</name><affiliation wicri:level="3"><nlm:affiliation>Wuhan No. 1 Hospital, Wuhan, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Wuhan No. 1 Hospital, Wuhan</wicri:regionArea><placeName><settlement type="city">Wuhan</settlement><region type="région">Hubei</region></placeName></affiliation></author><author><name sortKey="Chen, Wei" sort="Chen, Wei" uniqKey="Chen W" first="Wei" last="Chen">Wei Chen</name><affiliation wicri:level="1"><nlm:affiliation>The 1st Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>The 1st Affiliated Hospital of Xi'an Jiaotong University, Xi'an</wicri:regionArea><wicri:noRegion>Xi'an</wicri:noRegion></affiliation></author><author><name sortKey="Zhang, Yongchen" sort="Zhang, Yongchen" uniqKey="Zhang Y" first="Yongchen" last="Zhang">Yongchen Zhang</name><affiliation wicri:level="1"><nlm:affiliation>The 2nd Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>The 2nd Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing</wicri:regionArea><wicri:noRegion>Nanjing</wicri:noRegion></affiliation></author><author><name sortKey="Wang, Jing" sort="Wang, Jing" uniqKey="Wang J" first="Jing" last="Wang">Jing Wang</name><affiliation wicri:level="1"><nlm:affiliation>Chongqing Public Health Medical Center, Chongqing, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Chongqing Public Health Medical Center, Chongqing</wicri:regionArea><wicri:noRegion>Chongqing</wicri:noRegion></affiliation></author><author><name sortKey="Huang, Baofu" sort="Huang, Baofu" uniqKey="Huang B" first="Baofu" last="Huang">Baofu Huang</name><affiliation wicri:level="1"><nlm:affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing</wicri:regionArea><wicri:noRegion>Nanjing</wicri:noRegion></affiliation></author><author><name sortKey="Lin, Ye" sort="Lin, Ye" uniqKey="Lin Y" first="Ye" last="Lin">Ye Lin</name><affiliation wicri:level="3"><nlm:affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou</wicri:regionArea><placeName><settlement type="city">Jiangmen</settlement><region type="province">Guangdong</region></placeName></affiliation></author><author><name sortKey="Yang, Jiasheng" sort="Yang, Jiasheng" uniqKey="Yang J" first="Jiasheng" last="Yang">Jiasheng Yang</name><affiliation wicri:level="1"><nlm:affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou, Guangdong, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou, Guangdong</wicri:regionArea><wicri:noRegion>Guangdong</wicri:noRegion></affiliation></author><author><name sortKey="Cai, Wensheng" sort="Cai, Wensheng" uniqKey="Cai W" first="Wensheng" last="Cai">Wensheng Cai</name><affiliation wicri:level="1"><nlm:affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing</wicri:regionArea><wicri:noRegion>Nanjing</wicri:noRegion></affiliation></author><author><name sortKey="Wang, Xuefeng" sort="Wang, Xuefeng" uniqKey="Wang X" first="Xuefeng" last="Wang">Xuefeng Wang</name><affiliation wicri:level="1"><nlm:affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing</wicri:regionArea><wicri:noRegion>Nanjing</wicri:noRegion></affiliation></author><author><name sortKey="Cheng, Jing" sort="Cheng, Jing" uniqKey="Cheng J" first="Jing" last="Cheng">Jing Cheng</name><affiliation wicri:level="3"><nlm:affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou</wicri:regionArea><placeName><settlement type="city">Jiangmen</settlement><region type="province">Guangdong</region></placeName></affiliation></author><author><name sortKey="Chen, Zhiqiang" sort="Chen, Zhiqiang" uniqKey="Chen Z" first="Zhiqiang" last="Chen">Zhiqiang Chen</name><affiliation wicri:level="1"><nlm:affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing</wicri:regionArea><wicri:noRegion>Nanjing</wicri:noRegion></affiliation></author><author><name sortKey="Sun, Kangjun" sort="Sun, Kangjun" uniqKey="Sun K" first="Kangjun" last="Sun">Kangjun Sun</name><affiliation wicri:level="1"><nlm:affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing</wicri:regionArea><wicri:noRegion>Nanjing</wicri:noRegion></affiliation></author><author><name sortKey="Pan, Weimin" sort="Pan, Weimin" uniqKey="Pan W" first="Weimin" last="Pan">Weimin Pan</name><affiliation wicri:level="1"><nlm:affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing</wicri:regionArea><wicri:noRegion>Nanjing</wicri:noRegion></affiliation></author><author><name sortKey="Zhan, Zhifei" sort="Zhan, Zhifei" uniqKey="Zhan Z" first="Zhifei" last="Zhan">Zhifei Zhan</name><affiliation wicri:level="1"><nlm:affiliation>Hunan Provincial Center for Disease Control and Prevention, Changsha, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>Hunan Provincial Center for Disease Control and Prevention, Changsha</wicri:regionArea><wicri:noRegion>Changsha</wicri:noRegion></affiliation></author><author><name sortKey="Chen, Liyan" sort="Chen, Liyan" uniqKey="Chen L" first="Liyan" last="Chen">Liyan Chen</name><affiliation wicri:level="3"><nlm:affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou</wicri:regionArea><placeName><settlement type="city">Jiangmen</settlement><region type="province">Guangdong</region></placeName></affiliation></author><author><name sortKey="Ye, Feng" sort="Ye, Feng" uniqKey="Ye F" first="Feng" last="Ye">Feng Ye</name><affiliation wicri:level="3"><nlm:affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</nlm:affiliation><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou</wicri:regionArea><placeName><settlement type="city">Jiangmen</settlement><region type="province">Guangdong</region></placeName></affiliation></author></analytic><series><title level="j">Journal of medical virology</title><idno type="eISSN">1096-9071</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The outbreak of the novel coronavirus disease (COVID-19) quickly spread all over China and to more than 20 other countries. Although the virus (severe acute respiratory syndrome coronavirus [SARS-Cov-2]) nucleic acid real-time polymerase chain reaction (PCR) test has become the standard method for diagnosis of SARS-CoV-2 infection, these real-time PCR test kits have many limitations. In addition, high false-negative rates were reported. There is an urgent need for an accurate and rapid test method to quickly identify a large number of infected patients and asymptomatic carriers to prevent virus transmission and assure timely treatment of patients. We have developed a rapid and simple point-of-care lateral flow immunoassay that can detect immunoglobulin M (IgM) and IgG antibodies simultaneously against SARS-CoV-2 virus in human blood within 15 minutes which can detect patients at different infection stages. With this test kit, we carried out clinical studies to validate its clinical efficacy uses. The clinical detection sensitivity and specificity of this test were measured using blood samples collected from 397 PCR confirmed COVID-19 patients and 128 negative patients at eight different clinical sites. The overall testing sensitivity was 88.66% and specificity was 90.63%. In addition, we evaluated clinical diagnosis results obtained from different types of venous and fingerstick blood samples. The results indicated great detection consistency among samples from fingerstick blood, serum and plasma of venous blood. The IgM-IgG combined assay has better utility and sensitivity compared with a single IgM or IgG test. It can be used for the rapid screening of SARS-CoV-2 carriers, symptomatic or asymptomatic, in hospitals, clinics, and test laboratories.</div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">32104917</PMID><DateRevised><Year>2020</Year><Month>04</Month><Day>13</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1096-9071</ISSN><JournalIssue CitedMedium="Internet"><PubDate><Year>2020</Year><Month>Feb</Month><Day>27</Day></PubDate></JournalIssue><Title>Journal of medical virology</Title><ISOAbbreviation>J. Med. Virol.</ISOAbbreviation></Journal><ArticleTitle>Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis.</ArticleTitle><ELocationID EIdType="doi" ValidYN="Y">10.1002/jmv.25727</ELocationID><Abstract><AbstractText>The outbreak of the novel coronavirus disease (COVID-19) quickly spread all over China and to more than 20 other countries. Although the virus (severe acute respiratory syndrome coronavirus [SARS-Cov-2]) nucleic acid real-time polymerase chain reaction (PCR) test has become the standard method for diagnosis of SARS-CoV-2 infection, these real-time PCR test kits have many limitations. In addition, high false-negative rates were reported. There is an urgent need for an accurate and rapid test method to quickly identify a large number of infected patients and asymptomatic carriers to prevent virus transmission and assure timely treatment of patients. We have developed a rapid and simple point-of-care lateral flow immunoassay that can detect immunoglobulin M (IgM) and IgG antibodies simultaneously against SARS-CoV-2 virus in human blood within 15 minutes which can detect patients at different infection stages. With this test kit, we carried out clinical studies to validate its clinical efficacy uses. The clinical detection sensitivity and specificity of this test were measured using blood samples collected from 397 PCR confirmed COVID-19 patients and 128 negative patients at eight different clinical sites. The overall testing sensitivity was 88.66% and specificity was 90.63%. In addition, we evaluated clinical diagnosis results obtained from different types of venous and fingerstick blood samples. The results indicated great detection consistency among samples from fingerstick blood, serum and plasma of venous blood. The IgM-IgG combined assay has better utility and sensitivity compared with a single IgM or IgG test. It can be used for the rapid screening of SARS-CoV-2 carriers, symptomatic or asymptomatic, in hospitals, clinics, and test laboratories.</AbstractText><CopyrightInformation>© 2020 The Authors. Journal of Medical Virology Published by Wiley Periodicals, Inc.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Li</LastName><ForeName>Zhengtu</ForeName><Initials>Z</Initials><AffiliationInfo><Affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yi</LastName><ForeName>Yongxiang</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>The 2nd Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Luo</LastName><ForeName>Xiaomei</ForeName><Initials>X</Initials><AffiliationInfo><Affiliation>Chongqing Public Health Medical Center, Chongqing, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Xiong</LastName><ForeName>Nian</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Liu</LastName><ForeName>Yang</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>The 1st Affiliated Hospital of Nanchang University, Nanchang, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Li</LastName><ForeName>Shaoqiang</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sun</LastName><ForeName>Ruilin</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou, Guangdong, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wang</LastName><ForeName>Yanqun</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hu</LastName><ForeName>Bicheng</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Wuhan No. 1 Hospital, Wuhan, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chen</LastName><ForeName>Wei</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>The 1st Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zhang</LastName><ForeName>Yongchen</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>The 2nd Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wang</LastName><ForeName>Jing</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Chongqing Public Health Medical Center, Chongqing, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Huang</LastName><ForeName>Baofu</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lin</LastName><ForeName>Ye</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yang</LastName><ForeName>Jiasheng</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Pulmonary and Critical Care Medicine, Guangdong Second Provincial General Hospital, Guangzhou, Guangdong, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cai</LastName><ForeName>Wensheng</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wang</LastName><ForeName>Xuefeng</ForeName><Initials>X</Initials><Identifier Source="ORCID">http://orcid.org/0000-0001-8854-275X</Identifier><AffiliationInfo><Affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cheng</LastName><ForeName>Jing</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chen</LastName><ForeName>Zhiqiang</ForeName><Initials>Z</Initials><AffiliationInfo><Affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sun</LastName><ForeName>Kangjun</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pan</LastName><ForeName>Weimin</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Jiangsu Medomics Medical Technology Co., Ltd, Nanjing, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zhan</LastName><ForeName>Zhifei</ForeName><Initials>Z</Initials><AffiliationInfo><Affiliation>Hunan Provincial Center for Disease Control and Prevention, Changsha, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chen</LastName><ForeName>Liyan</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ye</LastName><ForeName>Feng</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>02</Month><Day>27</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>J Med Virol</MedlineTA><NlmUniqueID>7705876</NlmUniqueID><ISSNLinking>0146-6615</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">COVID-19</Keyword><Keyword MajorTopicYN="N">SARS-CoV-2 virus infection</Keyword><Keyword MajorTopicYN="N">fingerstick blood</Keyword><Keyword MajorTopicYN="N">lateral flow immunoassay</Keyword><Keyword MajorTopicYN="N">point-of-care testing</Keyword><Keyword MajorTopicYN="N">rapid IgM-IgG combined test</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>02</Month><Day>24</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>02</Month><Day>26</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>2</Month><Day>28</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>2</Month><Day>28</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>2</Month><Day>28</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>aheadofprint</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">32104917</ArticleId><ArticleId IdType="doi">10.1002/jmv.25727</ArticleId></ArticleIdList><ReferenceList><Title>REFERENCES</Title><Reference><Citation>WHO. 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PLOS Pathog. 2017;13(11):e1006684.</Citation></Reference></ReferenceList></PubmedData></pubmed><affiliations><list><country><li>République populaire de Chine</li></country><region><li>Guangdong</li><li>Hubei</li><li>Jiangxi</li></region><settlement><li>Jiangmen</li><li>Nanchang</li><li>Wuhan</li></settlement></list><tree><country name="République populaire de Chine"><region name="Guangdong"><name sortKey="Li, Zhengtu" sort="Li, Zhengtu" uniqKey="Li Z" first="Zhengtu" last="Li">Zhengtu Li</name></region><name sortKey="Cai, Wensheng" sort="Cai, Wensheng" uniqKey="Cai W" first="Wensheng" last="Cai">Wensheng Cai</name><name sortKey="Chen, Liyan" sort="Chen, Liyan" uniqKey="Chen L" first="Liyan" last="Chen">Liyan Chen</name><name sortKey="Chen, Wei" sort="Chen, Wei" uniqKey="Chen W" first="Wei" last="Chen">Wei Chen</name><name sortKey="Chen, Zhiqiang" sort="Chen, Zhiqiang" uniqKey="Chen Z" first="Zhiqiang" last="Chen">Zhiqiang Chen</name><name sortKey="Cheng, Jing" sort="Cheng, Jing" uniqKey="Cheng J" first="Jing" last="Cheng">Jing Cheng</name><name sortKey="Hu, Bicheng" sort="Hu, Bicheng" uniqKey="Hu B" first="Bicheng" last="Hu">Bicheng Hu</name><name sortKey="Huang, Baofu" sort="Huang, Baofu" uniqKey="Huang B" first="Baofu" last="Huang">Baofu Huang</name><name sortKey="Li, Shaoqiang" sort="Li, Shaoqiang" uniqKey="Li S" first="Shaoqiang" last="Li">Shaoqiang Li</name><name sortKey="Lin, Ye" sort="Lin, Ye" uniqKey="Lin Y" first="Ye" last="Lin">Ye Lin</name><name sortKey="Liu, Yang" sort="Liu, Yang" uniqKey="Liu Y" first="Yang" last="Liu">Yang Liu</name><name sortKey="Luo, Xiaomei" sort="Luo, Xiaomei" uniqKey="Luo X" first="Xiaomei" last="Luo">Xiaomei Luo</name><name sortKey="Pan, Weimin" sort="Pan, Weimin" uniqKey="Pan W" first="Weimin" last="Pan">Weimin Pan</name><name sortKey="Sun, Kangjun" sort="Sun, Kangjun" uniqKey="Sun K" first="Kangjun" last="Sun">Kangjun Sun</name><name sortKey="Sun, Ruilin" sort="Sun, Ruilin" uniqKey="Sun R" first="Ruilin" last="Sun">Ruilin Sun</name><name sortKey="Wang, Jing" sort="Wang, Jing" uniqKey="Wang J" first="Jing" last="Wang">Jing Wang</name><name sortKey="Wang, Xuefeng" sort="Wang, Xuefeng" uniqKey="Wang X" first="Xuefeng" last="Wang">Xuefeng Wang</name><name sortKey="Wang, Yanqun" sort="Wang, Yanqun" uniqKey="Wang Y" first="Yanqun" last="Wang">Yanqun Wang</name><name sortKey="Xiong, Nian" sort="Xiong, Nian" uniqKey="Xiong N" first="Nian" last="Xiong">Nian Xiong</name><name sortKey="Yang, Jiasheng" sort="Yang, Jiasheng" uniqKey="Yang J" first="Jiasheng" last="Yang">Jiasheng Yang</name><name sortKey="Ye, Feng" sort="Ye, Feng" uniqKey="Ye F" first="Feng" last="Ye">Feng Ye</name><name sortKey="Yi, Yongxiang" sort="Yi, Yongxiang" uniqKey="Yi Y" first="Yongxiang" last="Yi">Yongxiang Yi</name><name sortKey="Zhan, Zhifei" sort="Zhan, Zhifei" uniqKey="Zhan Z" first="Zhifei" last="Zhan">Zhifei Zhan</name><name sortKey="Zhang, Yongchen" sort="Zhang, Yongchen" uniqKey="Zhang Y" first="Yongchen" last="Zhang">Yongchen Zhang</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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